The legal system of metrological activity in Spain is regulated by Law 3/1985 of 18 March of Metrology, as amended by the Royal Decree of Law 1296/1986 of 28 June, amending Law 3/1985, of March 18, Metrology, and EEC metrological control is established. Under this legal framework, a number of Community directives have been transposed concerning various types of measuring instruments, drawn up in the framework of Council Directive 71 /316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to the the laws of the Member States on the provisions common to measuring instruments and methods of metrological control.

Law 3/1985, of March 18, of Metrology, was developed, in relation to the metrological control of the State of instruments, apparatus, means and systems of measurement, by the Royal Decrees 1616/1985, of September 11, by the establishing the metrological control carried out by the State Administration; 1617/1985 of 11 September establishing the procedure for the clearance of officially approved metrological verification laboratories; 1618/1985 of 11 September 1985 establishing the Register of Metrological Control, repealed by Royal Decree 914/2002 of 6 September and Royal Decree 597/1988 of 10 June 1988 regulating the EEC Metrological Control.

On the other hand, the Constitutional Court in its judgments of 13 May and 12 December 1991 issued two rulings on the application of unconstitutionality raised by the Autonomous Community of Catalonia and on various positive conflicts of competence also raised by the autonomous communities of Catalonia, the Basque Country and Andalusia against the abovementioned metrological legislation, declaring that it is for the autonomous communities mentioned above. ownership of the executive powers provided for in the Royal Decrees 1616/1985, 1617/1985, and 1618/1985, all of them of September 11, and Royal Decree 597/1988, of June 10.

The growth and development of the single European market and the ongoing evolution of the technology of measuring instruments has advised the need to adapt existing European legislation on such instruments, adaptation which has been reflected in Directive 2004 /22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments, the transposition of which is carried out by this royal decree into Spanish national law.

The Council of the European Union approved a new operating system in the technical field, which encompasses most of the metrological controls carried out under the old approach in legal metrological control, known as a "global approach", which drastically changes the control systems exercised by the Member States on measuring instruments and which has been reflected in various Council provisions and already implemented in the Directive 90 /384/EEC of 20 June on the approximation of the laws of the Member States relating to the non-automatic weighing instruments.

The directive being transposed, based on the principles of the "new approach" (Council Resolution of 7 May 1985), on the overall approach (Council Resolution of 21 December 1989) and on the Council Decision 90 /683/EEC, as amended and replaced by Decision 93 /465/EEC concerning conformity assessment modules, provides appropriate solutions to ensure a high level of metrological protection, facilitates the harmonisation of legislation National and European specific to the measuring instruments, it provides for evaluation procedures modular type, some of them based on the application of quality management systems and allows and encourages greater involvement and involvement of industry and the private sector.

At the national level and in accordance with the judgments of the Constitutional Court in the past, the ownership of the executive powers in the field of State metrological control is the responsibility of the communities. The rules contained in this rule are attributed to them, determining that it is up to the competent public administration, in its territorial scope, to comply with and enforce this legislation.

Therefore, bearing in mind that this rule is transposed by this directive, the principles that make up the relations between the countries of the European Union, such as that of mutual recognition, must also be observed. recognition that derives from the provisions of Articles 28 and 30 of the Treaty of Amsterdam. In the same way that this principle must be respected in this Community area, it must of course be maintained in the Spanish state area and therefore between the autonomous communities that make up it.

In line with the above, the regulation set out in this royal decree is in line with the content of Directive 2004 /22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments, in such a way that the stages of the metrological control of the State referred to in Article 7 (a) and (b) of Law No 3/1985 of 18 March of Metrology correspond to the procedure laid down in the Directive as an assessment of the conformity and which affect, as long as no new classes of instruments are incorporated, those covered by the annexes V a XIV. At the same time, as regards the instruments not covered by the Directive and subject to the metrological control of the State through various provisions, a similar procedure is laid down in those stages.

The State metrological control phases referred to in Section 2.c (d) and (e) of the Metrology Act's seventh article are developed in this royal decree and apply to all regulated instruments.

For all this, this rule aims, while adapting Spanish legislation to that of the European Union, to regulate it in accordance with the aforementioned judgments of the Constitutional Court and to incorporate into national legislation principles of the new approach directives.

This provision has been submitted to the procedure for information on technical standards and regulations, provided for in Directive 98 /34/EC of the European Parliament and of the Council of 22 June, as amended by the Directive 98 /48/EC of 20 July, as well as Royal Decree 1337/1999 of 31 July, which incorporates both directives into the Spanish legal order.

In its virtue, on the proposal of the Minister of Tourism and Trade, with the prior approval of the Minister of Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers, in its July 21, 2006 meeting.

DISPONGO:

CHAPTER I

Object and definitions

Article 1. Object.

This royal decree aims at the development of Chapter III of Law 3/1985, of 18 March, of Metrology, in accordance with the provisions of Directive 2004 /22/EC of the European Parliament and of the Council on the instruments of measure, also proceeding to develop Chapter V of that law.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

(a) "Certificate of conformity" means a document issued by a notified body or a metrological control body, in relation to a measuring instrument which proves that it is in conformity with the essential, metrological and technical, as set out in the specific regulation applicable to it.

(b) "periodic certificate of verification" means a document issued by an authorised metrological verification body, in relation to a measuring instrument which proves that it is in conformity with the requirements laid down in the specific regulations that apply to you.

(c) "Marketing" means making available for the first time in the European Union an instrument intended for a final user for consideration, or free of charge.

(d) "State metrological control" means a set of administrative and technical actions aimed at checking measuring instruments and their metrological requirements for reasons of public interest, health and safety public policy, public order, environmental protection, consumer protection, collection of taxes and charges, calculation of duties, charges, administrative penalties, conduct of judicial expertise, establishment of guarantees basic for fair trade, and all those which can be determined on a basis regulatory.

(e) "Designation" means authorization by the competent Public Administration, recognizing a body or natural or legal person, to carry out the specific tasks of the notified bodies, of control metrological or authorised metrological verification.

(f) "Distributor" means any natural or legal person acting on his own behalf or by delegation, based on a contractual relationship with the person responsible for the conformity of a measuring instrument and putting it into service.

g) "Policy Paper": a document containing technical specifications adopted by the International Organisation for Legal Metrology (OIML), which has been identified by the Committee on measuring instruments, established in the Directive 2004 /22/EC, and the references of which have been published in the C series of the Official Journal of the European Union.

(h) "Manufacturer" means any natural or legal person responsible for the conformity of a measuring instrument with the provisions of this royal decree, either for the purposes of placing on the market in his own name or for placing on the market for such purposes; own purposes.

(i) "Importer" means any natural or legal person established within the European Union who is responsible for the conformity of an instrument of measurement with the provisions of this royal decree, which he or she puts on the market or in service, for the purposes of marketing or for its own purposes, a measuring instrument where the manufacturer is not established in the European Union.

j) "Measurement instrument" means any device or system with measurement functions.

k) "Additional metrology marking" means a mark which certifies the specific conformity of a measuring instrument with the essential requirements laid down in the European directives for a new approach and metrological character.

(l) "CE marking" means a set of letters and symbols attesting to the conformity of a product, checked with the assessment procedures laid down, with the European Union directives applicable to it.

m) "national marking" means a set of letters and symbols attesting to the conformity of a product, checked with the assessment procedures established, with national specific regulations.

n) "Harmonised standard": a technical specification adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI) or either jointly by two or all of these bodies, at the request of the European Commission, in accordance with Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down an information procedure in the field of technical standards and regulations and of the rules governing the services of the information society and drawn up in accordance with the general guidelines agreed between the Commission and the European standardisation organisations.

n) "Notification" means the act of the competent public authorities calling on the Administrative Cooperation Agency to bring to the attention of the Commission and of the Member States of the European Union, as well as of the other competent Spanish public administrations, the designation of a notified body.

o) "metrological control body" means an entity, public or private, designated by a Spanish competent public authority for the conduct of the tests in accordance with a national specific regulation and issue of the relevant certificates or conformities in relation to the State's metrological control in the marketing and commissioning stage.

p) "notified body" means a public or private entity acting in conformity assessment procedures, designated as such, by the competent public administrations at the level of the European Union.

q) "Authorised metrological verification body" means an entity, public or private, designated by a Spanish competent public authority, for the performance and issuance of appropriate certification certificates (d) of the seventh article of Law 3/1985, of 18 March, of Metrology.

r) "Precinct" means any material or electronic element or elements that prevent access to certain parts of the instrument or system of measurement and if it occurs in an unauthorized manner, and the violation thereof.

s) "Püesta en servicio": the first use by the end user, in the European Union, of a measuring instrument for the purposes that was conceived.

t) "National specific regulation": specific legislation applicable to an instrument in the exclusive field of Spanish territory, in development of Law 3/1985, of 18 March, of Metrology.

u) "authorised repairer" means any natural or legal person responsible for the repair or modification of a measuring instrument, registered in the Register of Metrological Control by a competent public administration, in accordance with as set out in Chapter V.

v) "authorised representative" means the natural or legal person established in the European Union and to which a manufacturer authorises, in writing, to act on his behalf for the purposes of the application of this royal decree.

w) "Essential requirements": those requirements for the performance of mandatory performance and not design specifications, which provide a high level of metrological protection in order to enable the affected parties to have confidence in the measurement result.

x) "metrological and technical requirements": those relating to the design, operating parameters and administrative controls established by regulation or regulation, general or specific, at national level, for each type of instrument.

and) "Subset": physical device referred to as such in the specific regulation applicable to it, operating independently and in accordance with a measuring instrument together with other sub-assemblies or instruments of measure with which it is compatible.

z) "Verification after repair or modification": the set of administrative, visual and technical examinations that can be performed in a laboratory or in the place of use, which are intended to check and confirm that a The instrument of measurement in service maintains, after a repair or modification requiring the breaking of seals, the metrological characteristics that apply to it, in particular as regards the maximum permissible errors, as well as which works in accordance with its design and is in accordance with its specific rules and, where applicable, the approved design or model.

aa) "periodic verification" means the set of administrative, visual and technical examinations which may be carried out in a laboratory or in the place of use, which are intended to check and confirm that a measuring instrument in the service has maintained since its last verification the metrological characteristics that apply to it, in particular as regards the maximum permissible errors, as well as that it works according to its design and is in conformity with its regulations specifies, and where appropriate, the approved design or model.

CHAPTER II

State metrological control. Marketing and commissioning phase

Article 3. Scope of application.

1. This Chapter, in accordance with the provisions of Article 7 (2) (a) and (b) of Law 3/1985, of 18 March, of Metrology, and the Directive of the European Parliament and of the Council 2004 /22/EC on measuring instruments, establishes and regulates the marketing and putting into service phase applicable to the measuring instruments subject to specific regulatory control of the State.

2. In accordance with Article 7 (1) and (3) of Law No 3/1985 of 18 March 1985 on Metrology, instruments, apparatus, means and systems of measurement which are used for weighing, measuring or counting and which are used in applications for action for reasons of public interest, public health and safety, public order, environmental protection, consumer and user protection, collection of taxes and charges, calculation of tariffs, charges, penalties (a) administrative procedures, the establishment of judicial expertise, the establishment of basic guarantees for a fair trade and all those which can be determined on a regulatory basis, shall be subject to State metrological control, where it is established, or established, by specific regulation.

3. Measuring instruments, the use of which is different from the applications specified in the previous point, may be marketed and put into service freely in accordance with the specific conditions laid down for such cases in Article 8.4.

4. The metrological control phase of the State developed in this Chapter shall apply to measuring instruments prior to their putting into service, on the basis of the conformity assessment procedures laid down in Article 6 and developed in Annex III.

5. The provisions of this royal decree will also apply to subsets for which particular requirements are laid down in the specific regulations for each type of instrument. The measuring instruments and their sub-assemblies may be evaluated for the purpose of establishing their conformity independently.

Article 4. Competence and enforcement.

1. The Autonomous Communities shall be responsible for the compliance with the provisions of this Chapter with regard to State metrological control.

2. The activities related to the conformity assessment procedures determined for the implementation of the metrological control of the State at the level of the European Union provided for in this Chapter shall be carried out by the bodies. notified, taking into account the provisions of this royal decree, the applicable specific regulations and the technical and coordination guidelines emanating from the Commission of the European Union and the High Council of Metrology, where appropriate.

3. The activities related to conformity assessment procedures for the implementation of the State metrological control provided for in this Chapter in application of a national specific regulation, i.e. the instruments for (a) where there is no harmonised European regulation by a directive, they shall be carried out by the departments of the competent public authorities or, where appropriate, by any metrological control body recognised in the State, taking into account the established in this royal decree, the specific rules applicable and the technical and coordination guidelines emanating from the Higher Council of Metrology.

Article 5. Essential, metrological and technical requirements.

1. The essential, metrological and technical requirements, which must be met by the measuring instruments submitted to the State's metrological control, shall be as laid down in Annexes IV to XIV, or in the case of those laid down in regulation national specific.

2. The conformity of a measuring instrument with the essential, metrological and technical requirements shall be carried out in accordance with the conformity assessment procedures laid down in Article 6 and as determined for each instrument. with a specific character.

3. Where the competent public authorities consider that the instruments submitted to the State metrological control phase, as provided for in this Chapter, which incorporate the CE marking, or the national marking, do not comply with the requirements essential, metrological and technical, laid down in the specific regulation which is applicable to it, even if they have been correctly installed and used for the purposes for which they are intended, shall take the appropriate measures to ensure that are withdrawn from the market or are prohibited or restricted to use, notifying them of responsible for the marking and reporting to the Administrative Cooperation Agency, indicating both the reasons and justifications for the reasons for its decision.

4. The Administrative Cooperation Agency shall initiate the information procedure laid down in the safeguard clause of Article 19 of Directive 2004/22 EC or, in the case of application of a national specific regulation, communicate it to the Commission. to the other competent public administrations.

Article 6. Assessment of compliance.

1. The assessment of the conformity of a measuring instrument with the essential requirements for the harmonised application of EC and, where appropriate, metrological and technical implementation of a specific national regulation, shall be carried out in accordance with the of the compliance officer of the measuring instrument or its representative, one or more of the assessment procedures referred to in paragraph 2 of this Article and determined in the specific regulation of the instrument. The applicant for the conformity assessment shall provide the technical documentation for the specific instruments or groups of instruments as determined in their specific regulation and as set out in Article 9.

2. The modules used for conformity assessment, as set out in Annex III, are as follows:

a) Module A, compliance statement based on internal manufacturing control.

(b) Module A1, declaration of conformity based on internal manufacturing control plus tests performed on the product by an organism.

c) Module B, model exam.

d) Module C, declaration of compliance with the model based on internal manufacturing control.

e) Module C1, declaration of conformity with the model based on internal manufacturing control plus the tests performed on the product by an organism.

f) Module D, declaration of conformity to the model based on the quality assurance of the manufacturing process.

g) Module D1, compliance statement based on quality assurance of the manufacturing process.

h) Module E, declaration of conformity with the model based on the quality assurance of the inspection and testing of the finished product.

i) Module E1, declaration of conformity based on quality assurance of inspection and on tests performed on finished product.

j) Module F, declaration of compliance with the model based on product verification.

k) Module F, compliance statement based on product verification.

I) Module G, compliance statement based on unit verification.

m) Module H, compliance statement based on total quality assurance.

n) Module H1, compliance statement based on the total quality assurance plus the design exam.

3. The documents issued and the correspondence maintained by the notified bodies and the metrological control bodies with establishment in Spain relating to the conformity assessment shall be drawn up in accordance with the provisions of the Article 36 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

Article 7. Conformity marking.

1. The conformity of a measuring instrument with the provisions contained in this royal decree and with which it is determined in its specific regulation shall be recorded by the existence of an EC marking and the additional marking of the metrology or national marking, depending on the scope applicable in each case, as set out in Annex I.

2. The manufacturer or importer shall place or under his responsibility the corresponding marking of conformity, which may be affixed during the manufacturing process if justified for technical or production reasons.

3. The placing on a measuring instrument of an EC marking and additional marking of metrology or, where appropriate, a national marking, which may be misleading in terms of its meanings and forms, is prohibited. Any other marking may be affixed to a measuring instrument provided that the visibility and readability of the conformity marking which may correspond to it is not reduced.

4. Where a measuring instrument is subject to regulations transposing into national law other directives relating to other aspects which require a CE marking, the presumption of conformity with the requirements of this Directive shall be indicated in the such regulations. In such a case, in the documentation, brochures or instructions required by those regulations accompanying the measuring instrument, the references of the publication of those regulations and the directives they transpose must be incorporated.

5. Where it is determined that an EC marking and additional marking of metrology or a national marking has been affixed unduly, irrespective of the possible sanction to which it may give rise, the manufacturer or his authorised representative or, where appropriate, the a person who places the instrument on the market or distributes the instrument, shall be obliged to comply with the provisions on conformity marking and to end non-compliance.

In the event that the above non-compliance persists, appropriate measures shall be taken to ensure that they are withdrawn from the market or prohibited for use in accordance with the procedures in force. The Agency for Administrative Cooperation shall be informed, with reasoned and reasoned indication of the reasons for its decision. The Administrative Cooperation Agency shall initiate the information procedure laid down in the safeguard clause in Article 19 of Directive 2004 /22/EC or in the case of the application of a national specific regulation. to the other competent public administrations.

Article 8. Marketing and commissioning.

1. The measuring instruments which are the subject of this royal decree may be placed on the market and put into service in accordance with the provisions laid down therein and those laid down in the relevant specific regulation and which, consequently, incorporate, as appropriate, the CE marking and the additional metrology marking or national marking.

2. For the purpose of putting into service a measuring instrument, the requirements of climatic conditions and class of accuracy to be determined in the specific regulations applicable to them shall be met. In relation to the classes of accuracy, it shall be possible to use measuring instruments of an accuracy class higher than that stipulated in the specific regulation, if applicable, at the choice of its owner.

3. The display of measuring instruments is permitted at trade fairs, exhibitions, demonstrations, etc., which have not been subject to the provisions of this royal decree and its corresponding specific regulation, provided that indicate by a visible sign their non-compliance and their non-availability to be placed on the market or put into service.

4. The measuring instruments, used for applications other than those laid down in Article 3.2, may be placed on the market and put into service, without being applicable to the instruments laid down in this royal decree, provided that The manufacturer's mark or name, the relevant metrological characteristics of the instrument for use, as well as the legend 'Not subjected to metrological control', shall be visible in a visible, easily legible and indelible form.

Article 9. Technical documentation.

1. The technical documentation shall make it possible for the design, manufacture and operation of the measuring instrument to be easily interpretable and enable the assessment of its conformity with regard to the requirements applicable to it in its corresponding general and specific regulation.

2. This technical documentation shall be sufficiently detailed to ensure the definition of the metrological characteristics of the measuring instrument, the reproducibility of the metrological results of the instruments manufactured, when they are appropriately adjusted, using the appropriate means and the integrity of the instrument.

3. The technical documentation shall include, to the extent relevant, for the assessment and identification of the model or instrument:

1) A general description of the instrument;

2) Schemas of conceptual and manufacturing design and drawings of components, subsets, circuits, etc.;

3) manufacturing processes that ensure the consistency of production;

4) When applicable, a description of the electronic devices with drawings, diagrams, logic flow diagrams and general software information, which explain their characteristics and operation;

5) The descriptions and explanations necessary for the understanding of points (2), (3) and (4), including the operation of the instrument;

6) A list of the standards or normative documents or both referred to in Article 10, applied in full or in part;

7) Descriptions of the solutions adopted to meet the essential requirements where the standards or normative documents referred to in Article 10 have not been applied;

8) Results of design calculations, exams, etc.;

9) Where necessary, the results of the relevant tests showing that the model or instruments are in conformity with the requirements to be determined in the specific regulation applicable to them nominal operating conditions declared and with the specified environmental disturbances, as well as the durability specifications in the case of gas, water and thermal energy meters, as well as for systems for measurement continuous and dynamic quantities of liquids other than water;

10) Model exam certificates or design exam certificates for instruments that contain parts identical to those of the design.

4. The manufacturer shall specify whether the application of seals and marks and the place of installation of the first seals have been provided. Its characteristics, number and location shall be the subject of approval by the body carrying out the conformity assessment.

5. The manufacturer shall indicate, where appropriate, the conditions of compatibility with physical and functional connections between two appliances, sub-assemblies or separate systems.

Article 10. Harmonised standards and normative documents.

1. Compliance with essential requirements shall be presumed to be determined in accordance with the applicable specific regulations of the measuring instruments which comply with the characteristics laid down in national rules implementing rules. harmonised European references for which references have been published in the C series of the Official Journal of the European Union.

2. Where a measuring instrument partially meets the requirements of the national standards referred to in the preceding subparagraph, partial conformity shall also be presumed with those requirements which the instrument complies with.

3. Compliance with the essential requirements to be determined in accordance with the applicable specific regulations for measuring instruments that satisfy relevant parts of the normative documents and lists shall be presumed. identified by the Committee on measuring instruments of Directive 2004 /22/EC and the references of which have been published in the C series of the Official Journal of the European Union.

4. Where a measuring instrument complies only in part with the regulatory document referred to in paragraph 3 of this Article, compliance with the essential requirements corresponding to the regulatory elements shall be presumed to be comply.

5. The manufacturer may choose to adopt any technical solution that satisfies the essential requirements. In addition, in order to be able to benefit from the presumption of conformity, it shall properly and correctly apply the defined solutions either in the relevant harmonised European standards or in the relevant parts of the regulatory documents and lists referred to in paragraphs 1 and 3 of this Article.

6. Compliance with the tests which are established shall be presumed if they have been carried out in accordance with a programme in accordance with the relevant documents referred to in paragraphs 1 to 5 of this Article and their results guarantee the compliance with the essential requirements.

CHAPTER III

State metrological control. Instrument phase in service

Article 11. Scope of application and regulated verifications.

1. This Chapter, in accordance with the provisions of Article 7 (2) (c), (2) (d) and (2) and (e) of Law 3/1985 of 18 March 1985, develops the metrological control of the State of the measuring instruments in service.

2. In accordance with Article 7 (1) and (3) of Law No 3/1985 of 18 March 1985 on Metrology, the instruments being used for measuring applications for reasons of public interest, health and safety public policy, public order, environmental protection, consumer protection, collection of taxes and charges, calculation of duties, charges, administrative penalties, conduct of judicial expertise, establishment of guarantees basic for fair trade, and all those which can be determined on a basis Regulations and have been put into service on the basis of the provisions of Chapter II, shall be subject to the stages of the metrological control of the State governed by this Chapter in accordance with the applicable specific regulations.

3. For the purposes of the application of the provisions of this Chapter, the instruments of measurement in service, subject to the metrological control of the State by specific regulation, shall be subject to verification after repair or modification, periodic verification and surveillance and inspection, as appropriate, in accordance with paragraph 2 (c) and (d) of Article 7 of Law 3/1985 of 18 March of Metrology.

Article 12. Metrological and technical requirements and verification procedures.

1. The essential, metrological and technical requirements that an instrument must continue to comply with from putting into service shall be those laid down by specific regulation.

2. The conformity of a measuring instrument with the applicable essential, metrological and technical requirements shall be carried out in accordance with the verification procedures laid down in its specific regulations which shall include: metrological, technical and administrative requirements to be met, the procedures to be used, the period of validity of the verification, documents to be issued and maintained and any other aspects which, depending on the characteristics of the instrument, deemed necessary.

Article 13. Competence and enforcement.

1. The Autonomous Communities shall be responsible for compliance with the provisions of this Chapter with regard to State metrological control.

2. The metrological control phase of the regulated State in this chapter shall be carried out, except in the case determined in Article 14.3, by the competent public administration where the measuring instrument is located for the intended purpose. of their use, taking into account what is established in this royal decree, the specific regulations for each type of measuring instrument and the technical and coordination guidelines emanating from the Superior Council of Metrology.

3. The competent public authorities may designate authorised metrological verification bodies which shall be responsible for the implementation of the activities related to the verification procedures, in application of the national specific regulations referred to in stages 2 (c) and 2 (d) referred to in Article 11.3 of this Royal Decree.

Article 14. Bound subjects.

1. Those who use or hold, for the purposes of property, leasing or other similar financial arrangements, an instrument of measure in service for the purposes referred to in Article 11.2, shall be required to apply for such verification. in the situations or periods for which it is laid down in its specific regulation. By ministerial order the subject must be determined in each case.

2. The application for verification in each case shall be submitted to the competent public administration where the measuring instrument is installed.

3. In the case of measuring instruments with a roaming use, the application shall be submitted to the competent public administration where the taxable address of the subject is situated.

Article 15. Authorized repairers.

1. The repair or modification of the measuring instruments subject to metrological control of the State shall be carried out by a person or entity registered as a repairer in the Register of Metrological Control in accordance with the provisions of Chapter V and technical requirements to be laid down in the applicable specific regulation.

2. Persons or entities which have repaired or modified a measuring instrument, having checked their correct operation and which the results of their measurements are within the maximum permissible errors, shall be placed in the once again the seals which they have had to lift for intervention and shall complete the documents to be determined in the specific regulations.

Article 16. Conformity marking.

1. After the metrological control of the State covered by this Chapter, the conformity of the measuring instrument shall be recorded in order to perform its function by attaching a label to a visible place of the instrument verified or of the installation which support, which shall meet the characteristics and requirements set out in Annex I to this Royal Decree. The corresponding certificate of verification shall also be issued.

2. Where a measuring instrument does not exceed the metrological control phase which is the subject of this chapter, it shall be put out of service until the deficiency which has led to the failure to overcome is remedied. In the event that such a deficiency is not remedied, appropriate measures shall be taken to ensure that it is definitively withdrawn from the service. This shall be recorded by means of a disable label of use, the characteristics of which are indicated in Annex I, located in a visible place of the instrument,

Article 17. Surveillance and Inspection.

1. The surveillance and inspection referred to in Article 7 (2) (e) of Law 3/1985 of 18 March of Metrology shall be aimed at verifying that, in the manufacture, placing on the market, putting into service and use of a measuring instrument, have complied with the requirements laid down in this royal decree and in the applicable specific regulations.

2. In the field of their powers, public administrations shall take appropriate measures to prevent the measuring instruments subject to the metrological control of the State which do not comply with the provisions laid down in this royal decree and in their specific regulations, are placed on the market or put into service as appropriate. Public administrations shall also ensure that the adjustment of the average error of the instruments in service is at zero value.

3. Surveillance and inspection activities are initiated on a formal basis, on a complaint basis, by collaboration agreements as part of an inspection plan or as part of campaigns at European, state or regional level, and include the following: The following aspects: existence and compliance of the established conformity marking for the placing in service and use; existence and status of the seals; correspondence with the original designs of the instrument or in its case with the authorised modifications; compliance with the metrological and operational requirements; and correction of the installation to the intended purpose.

4. Each surveillance or inspection action shall be recorded in a report or in a report, in accordance with the regulations of the competent public authorities, which may serve as a basis for the processing of the appropriate sanctioning procedure and the content of which shall be presumed to be certain, unless otherwise proved. It shall include, inter alia, the identification data of the inspected natural or legal person, the reasons for the inspection, the measuring instruments on which the inspection took place, the phases of the metrological control affected as well as all deficiencies and inobservances that have been detected during the inspection.

5. For the purposes of their knowledge by the other Administrative Cooperation Bodies of the Member States of the European Union and of the competent national public administrations, they shall, through the Cooperation Agency, They shall report on the inspection programmes they intend to carry out and their results.

6. Manufacturers, or those responsible for the marketing of an instrument, as well as the holders of instruments in service under metrological control of the State, are obliged to provide the inspector with their cooperation and all the precise means for the exercise of its functions and in particular to provide and permit the reproduction of all information, data and documents on the instruments inspected and metrological controls carried out, allowing the carry out the appropriate sampling or testing and study as well as practice any other legally admitted test. Failure to comply with the obligation laid down in this paragraph shall constitute an infringement on metrological matters.

7. The competent public authorities shall provide the natural or legal persons subject to inspection with the necessary information for the proper exercise of their rights.

CHAPTER IV

Acting agencies and technical and administrative cooperation

Article 18. Administrative Cooperation Body.

1. The Spanish Metrology Centre is the Agency for Administrative Cooperation for the exchange of information with the partner bodies designated for this purpose by the other Member States of the European Union and with the European Commission. as with the competent public administrations, in relation to the procedures for the assessment of conformity and market surveillance of instruments subject to State metrological control.

In particular, it will be exchanged:

Information on the test results and the degree of compliance with the applicable provisions of the measuring instruments examined.

Certificates of EC model and EC examinations of design, with annexes issued by Spanish notified bodies, as well as additional modifications or revocations in relation to certificates issued.

Approvals of quality management systems issued by notified bodies, as well as information regarding their refusal or revocation.

Assessment reports prepared by notified bodies at the request of public administrations.

2. The Administrative Cooperation Agency shall make available to public administrations with competence in metrology the information it receives from its European counterparts, which shall, in turn, inform the notified bodies and the metrological control they have designated.

3. The Administrative Cooperation Agency shall make available to public administrations with competence in metrology the information relating to the actions carried out by each of them in accordance with the rules of procedure. national specific. For these purposes, the authorities concerned shall inform the Administrative Cooperation Agency of their actions. In particular they shall be exchanged:

Registrations, authorisations, modifications and revocations of notified bodies, metrological control bodies, authorised metrological verification bodies and authorised repairers.

Information on the test results and the degree of compliance with the applicable provisions of the measuring instruments examined.

Model and design exam certificates, additional modifications, or revocations.

Approvals of quality management systems issued, as well as information regarding the refusal or revocation of such systems.

Compliance assessment reports prepared by metrological control bodies at the request of the public administrations.

Reports of surveillance and inspection actions carried out on measuring instruments in the different stages of marketing, commissioning and use.

Article 19. Notified bodies, metrological control and metrological verification bodies.

1. Public administrations in their field of competence are responsible for the designation of the notified bodies and for metrological control which they consider necessary to carry out the action on the measuring instruments. to assess their compliance with the essential, metrological and technical requirements which they apply to them in accordance with their specific rules, to the effect of which, taking into account the guidelines laid down by the Superior Council of Metrology and once verified the fulfillment of the requirements stipulated in the Annex II shall issue a corresponding Resolution of the designation of the body, establishing its composition, the activities to be carried out in the field of State metrological control and the instruments in which it can act, informing the Administrative Cooperation Body.

2. Public administrations in their field of competence are responsible for the designation of the authorised metrological verification bodies which they consider necessary to carry out the action on the measuring instruments in the service relating to the steps of metrological control referred to in Article 7 (c) and (d) of Law 3/1985, of Metrology, to which effect, after verification of compliance with the requirements laid down in Annex II, it shall issue the corresponding Resolution of designation of the body, establishing its composition, activities to be carried out in the field of metrological control of the State and the instruments in which it can act, informing the Agency of Administrative Cooperation.

3. The compatibility of activities as a notified body or of metrological control and as an authorised metrological verification body shall be presumed in the event that the activities are carried out directly by an Administration or Agency. public. In other cases, it shall be carried out in such a way that there is no conflict of interest due to the customer or the product under metrological control. The competent Spanish authorities shall ensure compliance with this criterion.

4. Notified bodies, metrological control bodies and metrological verification bodies shall not be allowed to subcontract tasks to other related agents in the manner described in the previous paragraph. Nor shall they subcontract tasks to repairers of instruments subject to metrological control.

5. Documents and certificates relating to metrological checks carried out by notified bodies designated by any competent authority of the European Union are valid at any place and before any authority thereof.

6. The documents and certificates relating to the metrological checks carried out by the metrological control bodies for the stage referred to in Chapter II and the authorised metrological verification bodies for the regulated phase in the Chapter III, shall be valid throughout the territory of the State.

7. The Superior Council of Metrology, in accordance with the provisions of Article 11 of Law 3/1985, of 18 March, of Metrology, shall advise and coordinate the designation and surveillance of the notified bodies, of metrological control, and Metrological verification authorized.

8. Notified bodies, metrological control and metrological verification bodies, must demonstrate and continuously satisfy the requirements set out in Annex II and shall keep the competent public administration informed. which has designated you, of any modification that may affect compliance with the required requirements.

9. All bodies are obliged to keep the authority they have appointed them informed of their activities, and in particular those which have led to the refusal or revocation of the documents issued. They shall also submit annually a detailed report of their activities to the public administration which they have appointed.

10. If a notified body, of metrological control or metrological verification, no longer meets any of the conditions required for its designation, the competent public administration which has appointed it shall, after hearing the body, revoking resolution of its designation.

11. The Administrative Cooperation Agency, through the Secretariat of State for the European Union, shall process the resolutions for the designation of the notified bodies, for the purpose of assigning them the number of the European Commission. Likewise, the decision to revoke a notified body shall also be communicated to the Administrative Cooperation Agency, which shall inform the Commission and the rest of the decision by the Secretariat of State for the European Union. of the Member States.

12. Where a notified body or a metrological control body ceases to act for any reason in the conformity assessment procedures for which it has been designated, all the documents relating to the procedures of the conformity assessment shall be transferred to the Administration which designated it for a possible assignment of its custody to another body. This circumstance shall be communicated by the competent public administration to the Administrative Cooperation Agency.

13. The resolution of designation or revocation of a metrological or authorised metrological verification body shall be communicated to the Administrative Cooperation Agency.

CHAPTER V

Metrological control record

Article 20. Object.

This chapter comes to the development of the Metrological Control Register established in Article 8 of Law 3/1985, of March 18, of Metrology, as a single register of national scope, whose data will be centralized in the Spanish Center of Metrology, as the Agency of Administrative Cooperation established in this royal decree, from which the said register will depend. The management of this register is the responsibility of the competent public authorities.

Article 21. Content and purposes.

1. The Metrological Control Register must include the following information:

(a) Data relating to natural or legal persons acting in the field of State metrological control, as provided for in Article 8 (1) of Law 3/1985, of 18 March, of Metrology, as amended Article 176 of Law 13/1996, of December 30, of Fiscal, Administrative and Social Order Measures.

(b) Data relating to entities that may be designated as notified bodies, metrological control and metrological verification in Spanish territory for the performance of their activities in the framework of the metrological control of the State.

(c) Data relating to the results of the activities related to the conformity assessment procedures referred to in Chapter II.

(d) Data relating to the results of the surveillance and inspection activities regulated in this royal decree.

e) Those to be determined by the Higher Council of Metrology.

2. This register is regulated for the purpose of:

(a) Incorporate, maintain, safeguard the data relating to the actions which, in application of this royal decree, carry out the public administrations and the acting agencies within the framework that corresponds to them, between those related to Article 6, as well as the provisions set out in Article 17.5.

b) To provide the public authorities with the information necessary to carry out a coordinated activity of State metrological control.

c) Give publicity to facts and acts affecting the State's metrological control.

Article 22. Registration.

1. Natural or legal persons who manufacture, import, market, or lease instruments of measurement subject to the State's metrological control shall be registered, by the appropriate public administration, in the Register of Control. Metrological when requesting any substantive operation of a metrological character from among those regulated in Chapter II.

2. The notified bodies shall be entered in the Register of Metrological Control, designated by the competent public authorities as notified bodies, of metrological control and authorised metrological verification for the actions specified in the Chapters II and III of this royal decree.

3. Natural or legal persons who propose to repair measuring instruments subject to the State's metrological control, must apply for registration in the Register of Metrological Control with the competent services of the Autonomous Community in which has its registered office fixed.

Article 23. Application for registration.

1. The natural or legal persons referred to in Article 22.1, for the purposes of their registration in the Metrological Control Register, shall provide the following information:

(a) The name of the applicant, or the name or social name if he is a legal person.

b) Number of the national identity document or tax identification code.

c) The address of the applicant or the entity, if any.

d) Place of location of their facilities for the exercise of the activity recorded.

e) Fundamental characteristics of the measuring instruments that manufactures, imports, or markets, with an indication of the activity for which you want to be enrolled.

The following documents must be provided as attachments:

Authenticated photocopy of the identification document or tax identification code.

Photocopy of public deed or certificate of Commercial Registration or equivalent document that accredits the legal personality of the applicant.

2. Natural or legal persons not resident in a country belonging to the European Union or not a signatory to the Agreement on the European Economic Area, in addition to the data referred to in the preceding paragraph, shall also provide the registered office of residence. or activity on the territory of the European Union.

3. Public or private entities referred to in Article 22.2 shall be registered by the public authorities which appoint them, and shall obtain the following basic data from them:

a) Denomination or social reason.

b) The identification number assigned for the actions.

c) Tax identification code.

d) The entity's registered address.

e) Place of location of their facilities for the exercise of the registered activity.

f) Scope of the designation.

4. The natural or legal persons referred to in Article 22.3 shall record the following data in their application for registration in the Metrological Control Register:

(a) The name of the applicant, or the name or social name if he is a legal person.

b) Number of the national identity document or tax identification code.

c) The address of the applicant or the entity, if any.

d) Place of location of their facilities for the exercise of the activity recorded.

The following documents must be provided as attachments:

Authenticated photocopy of the NIF or CIF.

Photocopy of a public deed or a Commercial Registration certificate that accredits the legal personality of the applicant.

Detailed relationship of the staff engaged in the activity to be enrolled in your company, indicating first name, surname, national identity card number, qualification and experience.

The relationship of technical means available, duly accredited, to carry out the repairs that, if any, will be the ones that determine the specific regulations that apply to it.

Article 24. Identification of the inscriptions.

Any entry in the Metrological Control Register from among those provided for in Article 22 shall be assigned an alphanumeric identification, in the form set out in Annex XV.

Article 25. Certificate and validity of the registration.

1. The competent public administration shall issue an attestation of the registration in the cases referred to in Article 22.1 where it is requested by the registered office.

2. The competent public administration shall issue a certificate certifying that the bodies referred to in Article 22.2 have been registered in the Register.

3. In the case of the measuring instrument repairers, the public administration competent for registration in the Metrological Control Register shall issue a certificate certifying that it shall incorporate an annex including the whole of the information on the seals to be used on the sealing of the repaired instruments, with express indication of the shape, seal material and inscriptions of those instruments.

4. The registration certificates in the Metrological Control Register shall be valid for five years from the date of their issuance. The renewal of this must be requested by the person concerned before the public administration which made the registration one month before the date of its expiration, which will be understood as expired, communicating it to the person concerned. The renovation will be done for periods of five years.

Article 26. Data incorporation in the Metrological Control Registry.

For the purposes of incorporation into the Metrological Control Register, the competent public authorities shall send to the Spanish Metrology Centre the particulars of the inscriptions referred to in Articles 22 and 23.

Article 27. Modifying data.

Changes or changes in the circumstances documented for registration in the Metrological Control Register shall be communicated to the public administration that made the registration so that determine the origin or not of its incorporation, communicating it, to the Spanish Metrology Center in order to keep the Metrological Control Registry up to date.

For each subsequent registration, an additional registration certificate will be issued with the same assigned registration number, which will be added to the ordinal that will correspond to it, as long as the economic operator do not extend your activity to another sector.

Article 28. Cancellation of registration.

When the competent public administration finds that there has been distortion, inaccurate reporting or modification of the data and circumstances that served as a basis for registration in the Metrological Control Register, shall cancel it, by communicating it to the Spanish Metrology Centre, in order to keep the register up to date, without prejudice to the penalty to be given as provided for in Chapter VI.

Article 29. Advertising.

The data of the persons and entities registered in the Metrological Control Register, as well as the number of registered registration and the activity for which the registration has been obtained, shall be considered. public.

The Spanish Metrology Centre, in coordination with the competent public administrations, will take the necessary measures to ensure the compatibility of the computer systems and applications for the management of the Metrological control, so that the collection, transmission of data and advertising of the inscriptions are carried out with the greatest administrative efficiency.

CHAPTER VI

Violations and Sanctions Regime

Article 30. Object.

This chapter develops the sanctioning regime as determined in Chapter V of Law 3/1985, of March 18, of Metrology.

Article 31. Violations.

According to the provisions of Chapter V of Law 3/1985, of March 18, Metrology constitutes an infringement of the provisions of this royal decree, the acts or omissions that are determined in Articles 33, 34 and 35.

Article 32. Qualification and sanction of infringements.

The violations of the provisions of this royal decree will be classified as mild, serious and very serious in the light of the health risk criteria, the market position of the infringer, the degree of intentionality, the severity of the the social disruption produced, generalisation of the infringement and recidivism.

The minor infractions will be punished with a fine of up to 3,005.06 euros; the serious ones with a fine of 3,005.07 to 12,020,24 euros and the very serious ones with a fine of 12,020,25 to 60,101,21 euros.

The fines exceeding 12,020,24 euros will be agreed upon in the Council of Ministers, the lower of which will be imposed by the Minister of Industry, Tourism and Commerce.

Article 33. Minor infractions.

These are minor violations:

1. The person responsible for the instrument of documents which is legally required to do so shall not be responsible for the instrument or the instrument of legally enforceable identification or possession of such documents as is difficult to be visible or legible on the part of the consumers or users of the services of that person and of the officials or officials in the exercise of an action by the competent public administration.

2. Amend or breach non-essential conditions or requirements which resulted in the granting of the necessary administrative authorisations or ratings to support the manufacture, marketing, repair, modification, or use of the measuring instruments.

Article 34. Serious infringements.

These are serious violations:

1. Obstruction of the action of the agents or officials responsible for the inspection of metrological control activities and the unjustified refusal or resistance to display or provide the same instruments, documents or data as those claim in the exercise of their inspector function.

2. To place on the market or use instruments which, while subject to specific regulation of the State's metrological control in the stages specified in Chapters II and III, have not exceeded those stages, with the exception of those referred to in the Article 8.3.

3. Keep an instrument in service, without the regulations established.

4. The use of a measuring instrument when its errors exceed regulatory limits.

5. Use units of measure different from those laid down in the second article of Law 3/1985, of March 18, of Metrology and provisions that develop it.

6. Failure to comply with the requirements set out in Annex II, concerning notified bodies, metrological control and metrological verification and non-information to the competent public authority designated by it, of any modification that might affect them.

7. Lack of the patterns that have been established as mandatory, or possess them without the traceability required to guarantee their reliability and refuse, without justified cause, to provide them to those users who request to make regulatory use of them.

8. Failure to comply with obligations relating to the Metrological Control Register developed in Chapter V of this Royal Decree.

9. Improper affixing of CE marking and additional marking of metrology or a national marking, as well as the use of markings or labels with non-regulatory designs or which lead to confusion.

10. It is considered a serious infringement of the recidivism in the light of the minor fault for which it was sanctioned within the two years preceding the commission of the same.

Article 35. Very serious infringements.

These are very serious violations:

1. Carry out activities from among those regulated by this royal decree on measuring instruments submitted to the State's metrological control, without having obtained the corresponding administrative appointments and ratings.

2. To put into service the instruments which, having failed the various stages of metrological control of the State, have been put out of service, or their use has been prohibited, as long as the defects that gave rise to the adoption are not remedied. of the measures referred to.

3. Continue to perform the activities of a designation, recognition, or administrative enablement after it has been revoked.

4. Perform any manipulation on devices of the instrument, in order to fraudulently modify the result of the measurement.

5. It is considered a very serious infringement of the reoffending in serious misconduct for which it would have been sanctioned within the two years preceding the commission of the same.

TRANSIENT PROVISIONS

First. Term of validity of model approvals.

By way of derogation from Article 8, it shall be permitted, in respect of those measuring tasks for which the use of a legally controlled measuring instrument is required, for the placing on the market and putting into service of measuring instruments which comply with the rules applicable before 30 October 2006, until the expiry of the validity of the model approval of the measuring instruments in question or, in the case of an indefinite validity model approval, for a period not exceeding 10 years from 30 October 2006.

Second. Primitive verifications of instruments with model approval.

The instruments that would have obtained the model approval provided for in Royal Decree 1616/1985 of 11 September, prior to the entry into force of this royal decree may continue to be put into service, prior to submission to the original verification by the officially approved metrological verification laboratories, which were acting in accordance with the provisions of Royal Decree 1617/1985 of 11 September at the latest up to 30% of the October 2016.

Third. Period of adaptation of the services, entities and laboratories that were carrying out the verification control phases after repair or modification and periodic verification.

The services, entities and laboratories that were carrying out the activities related to the State metrological control phases that are determined in paragraph 2.c) and d) of the seventh article of Law 3/1985, of Metrology, they must be adapted to the provisions of this royal decree by 30 October 2008.

Fourth. Validity of the entries in the Metrological Control Register.

The natural or legal persons registered in the Register of Metrological Control at the entry into force of this royal decree, may continue to use the assigned registration number, for a maximum period of five years years, proceeding within that period to update the registration.

Fifth. Regulation applicable to instruments of measure subject to national specific legislation.

As long as the rules governing the activities relating to the metrological control stages laid down in paragraph 2 (c) and (d) of Law No 3/1985 of 18 March, of Metrology, are not adopted for the instruments referred to in Article 11.3 of this royal decree, shall continue to apply the provisions of the national specific regulations in force at the time of the entry into force of this royal decree.

REPEAL PROVISION

Unica. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they oppose the provisions of this royal decree, and in particular the following:

1. Royal Decree 1596/1982 of 18 June 1982 approving the Regulation for the approval of taquicronometric meters referred to as 'taximeters' (Directive 77 /95/EEC).

2. Royal Decree 875/1984 of 28 March 1984 approving the Regulation for the approval and early verification of induction meters for direct use (class 2) in direct connection, new, at simple tariff or multiple tariff, intended for the measurement of the active energy in single-phase and polyphasic frequency 50 Hz (Directive 76 /891/EEC).

3. Royal Decree 1616/1985 of 11 September establishing the Metrological Control carried out by the State Administration.

4. Royal Decree 1617/1985 of 11 September 1985 laying down the procedure for the clearance of officially approved metrological verification laboratories.

5. Royal Decree 914/2002 of 6 September for which the Register of Metrological Control is regulated.

6. Order of 27 January 1975 approving the Metrological Standard for medical syringes with glass bodies.

7. Order of the Presidency of the Government of 15 September 1980 for the approval of the Spanish Metrological Standard concerning "Medical syringes of plastic material to be used only once".

8. Order of 6 July 1988, for which the Metrological Standard for load cells is approved.

9. Order of 26 December 1988 for the control of gas volume meters (Directive 71 /318/EEC).

10. Order of 26 December 1988 for the control of volumetric meters of liquids other than water and their complementary devices (Directive 71 /319/EEC, 71 /348/EEC).

11. Order of 28 December 1988 for the treatment of cold water meters (Directive 75 /33/EEC) as regards the counters defined in Annex V to this Royal Decree.

12. Order of 28 December 1988 on the arrangements for the measurement of liquids other than water (Directive 77 /313/EEC).

13. Order of 28 December 1988 for the regulation of automatic weighting (Directive 78 /1031/EEC).

14. Order of 30 December 1988 for the measures to be taken into account (Directive 73 /362/EEC).

15. Order of 30 December 1988 for the regulation of instruments for the weighing of continuous totalisation (Directive 75 /410/EEC)

16. Order of 30 December 1988 for the control of hot water meters (Directive 79 /830/EEC).

17. Order of the Ministry of Public Works and Urbanism of 30 December 1988 on clinical mercury thermometers in glass and with maximum device.

18. Annex V to the Order of 22 December 1994 determining the conditions of the non-automatic weighing instruments.

19. Order of 15 April 1998 for the purpose of regulating the State's metrological control over instruments intended to measure emissions of exhaust gases from vehicles equipped with spark-ignition engines ('petrol ') in terms of its metrological control phases of model approval and primitive verification.

20. Order of 18 February 2000 regulating the State's metrological control over static active energy meters in alternating current, Classes 1 and 2, as regards the metrological controls of model approval and verification primitive.

21. Order FOM/1100/2002 of 8 May for the control of the State's metrological control over electric induction meters, class 2, in direct connection, at a simple rate or multiple tariffs, for the measurement of electrical energy active in monofasic and polyphase frequency 50 Hz electric current intensity, in its verification phases after repair or modification and periodic verification.

FINAL PROVISIONS

First. Competence title.

This royal decree is issued under the provisions of Article 149.1.12. of the Constitution, which gives the State exclusive competence to dictate the legislation on weights and measures.

Second. Enabling development and modification.

The Minister of Industry, Tourism and Trade is enabled to dictate how many provisions are necessary for the implementation and development of the provisions of this royal decree.

The necessary modifications to the technical contents of the Annexes, in order to keep them adapted to the progress of the technique and the Community and international standards in the field of metrology can be carried out by order of the Minister for Industry, Tourism and Trade.

Third. Entry into force.

This royal decree will enter into force on October 30, 2006.

Given in Palma de Mallorca, July 21, 2006.

JOHN CARLOS R.

The Minister of Industry, Tourism and Trade,

JOSE MONTILLA AGUILERA

ANNEX I

Identification of Marked and Metrological Control Record

Compliance Marked

1. The CE marking, as referred to in Article 7, shall consist of the EC symbol in accordance with the design laid down in point 1.B (d) of the Annex to Council Decision 93 /465/EEC of 22 July 1993. It shall be at least 5 mm high, according to the following model:

2. In the event of a reduction or increase in the CE marking, the proportions of the logo shall be retained.

3. The additional metrology marking shall consist of the letter M and the last two digits of the year in which it was applied, framed in a rectangle. The height of the rectangle shall be equal to the height of the CE marking. The additional metrology marking shall be immediately followed by the CE marking.

4. The national marking referred to in Article 7 shall consist of the letter m with a tilde above and the last two digits of the year in which it was applied, on a white background, framed in a rectangle and shall be at least 5 mm high.

5. Where required by the conformity assessment procedure, the identification number of the body concerned shall be located below the CE marking and the additional metrology marking or national marking, as appropriate.

6. When a measuring instrument consists of a group of devices operating together, which does not have the condition of subsets, the marking shall be placed on the main device of the instrument. However, when the main device is not visible, the marking of the most easily visible subset must also be carried out.

7. If, for reasons of size or sensitivity of the measuring instrument, it is not possible to apply the CE marking and the additional metrology marking or the national conformity marking, it shall be placed on the packaging, if any and the documentation required in the provisions of its specific regulation.

8. The conformity marking, as well as the identification number of the body carrying out the conformity assessment procedure, shall be indelible and the support on which they are printed shall be self-destruct if withdrawn. All marking shall be visible or easily accessible.

Verification label after repair or modification and periodic verification

9. Any measuring instrument that has passed a verification, in any of its modalities, shall bear a label that accredits it, the characteristics, format and content of which shall be as follows:

10. In the lower right side of the label, by drilling the corresponding boxes, the months and years to which the checks carried out are valid are indicated.

11. The label will be made with a material resistant to external agents, both atmospheric and abrasive and to the impacts. It will be of an adhesive type and self-destructive to the detachment. It will have rectangular shape and its dimensions will be 60 x 70 millimeters, having to maintain the proportions for other sizes.

12. When a measuring instrument consists of a group of devices operating together, which does not have the condition of subsets, the marking shall be placed on the main device of the instrument.

13. If for reasons of size or sensitivity of the measuring instrument it is not possible to apply the label, it shall be placed on the periphery of its installation and on the relevant documentation required by the provisions of its specific regulation.

Disable label for the service

14. Any measuring instrument that has not passed a verification, in any of its modalities, shall be affixed in a visible place to a disablement label for the service whose characteristics, format and content, shall be following:

The text "METROLOGICAL CONTROL", the text of the instrument type and the rating of "SERVICE OUT" will be in capital letter in black on red background. It shall also include the name of the verifying entity, its identification number and the date on which the check was carried out that resulted in the disablement for the service.

15. The label will be made with a material resistant to external agents, both atmospheric and abrasive and to the impacts. It shall be of an adhesive type and self-destructive to detachment. It shall have a rectangular shape and its dimensions shall be appropriate to the instrument in question and its visibility.

Identification of Metrological Control Record Enrollments

16. For the purposes of identifying the inscriptions of the Metrological Control Register as set out in Article 24, the following code tables are indicated:

Table 1: Identification codes for public administrations.

	Code
Spanish Center Metrology	00
Country Autonomous Community	01
Autonomous Community of Catalonia	02
Autonomous Community of Galicia	03
Autonomous Community of Andalusia	04
Autonomous Community	05
	06
06 La Rioja Autonomous Community	07
Region Autonomous Community
Community	09
Aragon	10
11	11	11	11	11	11	11	11	11
13
Community Extremadura Autonomous	14
Community of Madrid	15	Community
Castile and Lion Community	17

	Mass, force, and weigh.
E	Electricity.
G	Gases.
A	Water.
H
		D	Dimensional.
V	Volumetry.
C	Termometry and Calorimetry.
T	Time and
	Prepackaged.
1	Special instruments.

ANNEX II

Notified bodies, metrological control and verification of metrological verification

1. General requirements of the bodies and their staff appointed by the competent public authorities to act in the field covered by this Royal Decree:

(a) The body, its director and its staff involved in the tasks of the procedures of the marketing stages, and putting into service or phases of instruments in service, shall not be the designers, manufacturers, suppliers, installers or users of the measuring instruments which they check, nor shall they be authorised representatives of any of them. They shall also not be directly involved in the design, manufacture, marketing or maintenance of such instruments, nor may they represent parties involved in such activities. However, the criteria set out above shall in no way preclude the exchange of technical information between themselves and the body with a view to the assessment of conformity or the carrying out of the metrological controls of the instrument phase in service.

(b) The body, its director and its staff involved in the tasks of the procedures of the marketing and commissioning stages or in-service instruments shall be free from any pressure, (a) action and incentive, in particular economic order, which may affect their opinion or the results of their conformity assessment and control tasks, in particular by persons or groups of persons with interest in the the results of the evaluations.

c) The conformity assessment shall be carried out with the highest degree of professional integrity and with the necessary technical competence in the field of metrology. If the body subcontracts specific tasks, these tasks may not be those for evaluation or validation of results and shall ensure that the subcontractor concerned meets the requirements of this Royal Decree. The body shall keep at the disposal of the competent public authority which designated it, the relevant documents demonstrating the qualifications and work carried out by that subcontractor under this Royal Decree.

(d) The body shall be capable of carrying out all the tasks of the procedures of the stages of marketing and putting into service or phases of the instruments in service for which it has been designated, whether those tasks it is carried out by the body itself as if it is carried out on its behalf and under its responsibility. It will have at its disposal the necessary personnel and will have access to the necessary facilities to carry out the technical and administrative tasks properly involved in these procedures.

e) The staff of the body must have: adequate technical and professional training which includes all the tasks of the procedures of the marketing and commissioning stages or phases of instruments in the service, for which the body has been designated; satisfactory knowledge of the rules relating to the tasks it carries out and an adequate experience of them to directly assess the conformity of essential requirements, as well as the necessary expertise to draw up certificates, records and reports showing that The tasks were effectively performed.

(f) The impartiality of the body, its director and its staff must be guaranteed. The remuneration of the body will not depend on the results of the tasks performed. The remuneration of the director and staff of the body shall not depend on the number of tasks performed or the outcome of those tasks.

g) The body must have contracted a liability insurance covering the relevant circumstances of the activities carried out in the field of this Royal Decree, unless the liability is assumed by the body itself. Public administration under national law.

(h) The director and staff of the body shall be required to maintain professional secrecy with regard to any information obtained in the exercise of their duties under this Royal Decree, except for Competent Public Administration that has designated it.

(i) The body shall operate under an effective quality management system, appropriate to the procedure for the assessment of conformity or metrological control of instruments in service for which it is designated and which may come determined in specific regulations or in their case in guides of the Council of Metrology, the Commission or the Organization for Cooperation in the Legal Metrology of Western Europe (WELMEC).

(j) The agency is obliged to cooperate and to facilitate access to its facilities and archives to the Public Administration which designated it or the representatives designated by it for the performance of its surveillance activity, to provide all data, documents and information necessary to assess the correct performance of the procedures for which it has been designated. Failure to comply with these obligations shall result in the revocation of their designation.

k) The agency must commit itself to cooperate with the Public Administrations in the development and implementation of this Royal Decree. This includes the possible assistance to national or European working groups and the monitoring of possible technical guidelines to be developed by the Metrology Board.

(l) A body that carries out approval activities for quality management systems of manufacturers, must have expert personnel in audits of such systems, relating to the field of metrology and technology the instruments in question.

2. Specific requirements:

In addition, the personnel of the notified bodies, the metrological control bodies and the authorised metrological verification bodies involved in the metrological control activities must prove to be in possession of knowledge about:

(a) The specific regulations of the instruments subject to metrological control of the State, within the scope of this Royal Decree for which it is designated.

b) The applicable electromagnetic compatibility policy.

c) The general policy on subsets and particular clauses contained in the specific regulations involved.

d) The general policy on conformity assessment, as well as the nature of the different conformity assessment procedures.

e) The marking and inscriptions.

f) The designation, notification, and authorization procedure.

g) The tasks performed by the competent public administrations and the notified bodies themselves, metrological control bodies or authorised metrological verification bodies.

h) The application of this Royal Decree.

i) Harmonised standards, normative documents, national standards, guides, available and considered in the various activities of the body.

ANNEX III

Compliance assessment procedures

Generalities

The modules used for conformity assessment, which are developed in this annex, are used both at European and national level and in order to harmonise the terminology to be used independently of the Referred to and interpreted appropriately; the following is the meaning to be assigned to different terms.

1. Body: it shall comprise both the notified and the metrological control, depending on the European or national level, respectively, in which they act.

2. Applicable metrological regulation: it shall include the essential requirements set out in Annexes IV to XIV concerning the measuring instruments included in this Royal Decree, at European level, as well as the national specific regulation of those instruments. other instruments not covered by the annexes but subject to State metrological control.

3. Conformity marking: the CE marking plus the additional marking of metrology in the European legislative field shall be understood and shall be carried out by those instruments with specific Annexes to this Royal Decree which satisfy the essential requirements, as the national marking to be carried out by those other instruments not included in the Annexes, subject to State metrological control, which have national specific regulations and which satisfy them.

4. Model examination certificate: it shall include both the EC model examination certificate issued by a notified body in the European legislative field, and the model examination certificate issued by the control body in the field national exclusive legislative.

5. Design examination certificate: it shall include both the EC design certificate of the model issuing a notified body in the European legislative field, and the design examination certificate issued by the control body in the field national exclusive legislative.

MODULE A

Statement of compliance based on internal manufacturing control

1. The declaration of conformity based on internal manufacturing control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out below and ensures and declares that the measuring instruments in question satisfy the relevant requirements of the applicable metrological regulation.

Technical documentation

2. The manufacturer shall draw up the technical documentation in accordance with Article 9. This documentation shall allow the conformity of the instrument with the relevant requirements of the applicable metrological regulation to be assessed. It shall include, to the extent appropriate for such assessment, the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the competent public authorities for a period expiring 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured with the relevant requirements of the applicable metrological regulation.

Written Declaration of Compliance

5.1 The manufacturer shall apply the conformity marking to each measuring instrument that satisfies the relevant requirements of the applicable metrological regulation.

5.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

Authorized Representative

6. The manufacturer's obligations under points 3 and 5.2 may be fulfilled by his authorised representative on his behalf and under his responsibility.

When the manufacturer is not established in the European Union, or when he has no authorised representative, the obligations contained in points 3 and 5.2 shall be the responsibility of the person placing the instrument on the market.

MODULE A1

Statement of conformity based on internal manufacturing control plus tests performed on the product by an organism

1. The declaration of conformity based on the internal manufacturing control plus the tests carried out on the product by an organism is the conformity assessment procedure whereby the manufacturer fulfils the obligations which he or she determine in this module and ensures and declares that the measuring instruments in question satisfy the relevant requirements of the applicable metrological regulation.

Technical documentation

2. The manufacturer shall draw up the technical documentation in accordance with Article 9. This documentation shall allow the conformity of the instrument with the relevant requirements of metrological regulation to be assessed. It shall include, in so far as it is relevant to such assessment, the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the competent public authorities for a period expiring 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured with the relevant requirements laid down in the metrological regulation.

Product control

5. A body chosen by the manufacturer shall carry out or carry out checks on the product at the appropriate intervals to be determined by the manufacturer, in order to verify the quality of the internal production controls, taking into account, inter alia, the technological complexity of the instruments and the volume of production. A sample of the finished product, selected by the body prior to its placing on the market, shall be examined and appropriate tests shall be carried out in accordance with those described in the relevant document or documents referred to in Article 10; or equivalent tests, in order to verify the conformity of the instruments with the relevant requirements of the applicable metrological regulation. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

If a relevant number of sampling instruments does not reach an acceptable level of quality, the body shall take appropriate action.

Written Declaration of Compliance

6.1 The manufacturer shall apply to each measuring instrument that satisfies the relevant requirements, established in the metrological regulation, the conformity marking and under the responsibility of the acting body referred to in the Point 5, the identification number of that body.

6.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

Authorized Representative

7. The manufacturer's obligations under points 3 and 6.2 may be fulfilled by his authorised representative on his behalf and under his responsibility.

Where the manufacturer is not established in the European Union or when he is not authorised to be authorised representative, the obligations contained in points 3 and 6.2 shall be the responsibility of the person placing the instrument on the market.

MODULE B

Model Review

1. The model examination is part of a conformity assessment procedure whereby a body examines the technical design of a measuring instrument and ensures and declares that the technical design meets the relevant requirements of the applicable metrological regulation.

2. The model test can be done in any of the following ways. The body decides the appropriate mode and the necessary sample instruments:

(a) examination of a sample of the complete measuring instrument that is representative of the instrument to be manufactured;

b) examination of samples of one or more essential parts of the measuring instrument, which are representative of the product to be manufactured, plus assessment of the adequacy of the technical design of the other parts of the instrument measure by examination of the technical documentation and supporting documentation referred to in point 3;

(c) assessment of the adequacy of the technical design of the measuring instrument, without examining a sample of the instrument, by examining the technical documentation and supporting documentation referred to in point 3.

3. The application for the model examination shall be submitted by the manufacturer to a body of his choice. The request will include:

(a) The name and address of the manufacturer and, if the application is submitted by the authorised representative, also the name and address of the authorised representative.

b) Written statement that the same application has not been filed with any other body.

(c) The technical documentation described in Article 9. This documentation shall allow the conformity of the instrument with the relevant requirements laid down in the metrological regulation to be assessed. It shall include, in so far as it is relevant to such assessment, the design, manufacture and operation of the instrument.

(d) The samples, representative of the intended product, as required by the body.

e) The supporting documentation concerning the adequacy of the technical design of those parts of the measuring instrument for which it is not necessary to present samples. This supporting documentation shall mention any relevant regulatory document that has been applied, in particular where the relevant regulatory documents referred to in Article 10 have not been fully implemented, and shall also include: necessary, the results of the tests carried out by the competent laboratory of the manufacturer, or by another laboratory performing the tests on their behalf and under their responsibility.

4. The body shall:

As for the samples:

4.1 Examine the technical documentation, check that the samples have been manufactured in accordance with this documentation and identify the elements that have been designed in accordance with the relevant provisions of the appropriate regulatory documents referred to in Article 10, as well as the elements that have been designed without applying the relevant provisions of those regulatory documents.

4.2 To carry out, or have them carried out, the appropriate examinations and tests to check whether, when the manufacturer has chosen to apply the solutions corresponding to the said normative documents, his application has been correct.

4.3 To carry out, or have them carried out, the appropriate examinations and tests to check whether, when the manufacturer has chosen not to apply the solutions corresponding to the said normative documents, the solutions adopted by the manufacturer complies with the relevant requirements set out in the applicable metrological regulation.

4.4 Agree with the applicant where the examinations and tests should be carried out.

As for the other parts of the measuring instrument:

4.5 Examine the technical documentation and supporting documentation to assess the adequacy of the technical design of the other parts of the measuring instrument.

As for the manufacturing process:

4.6 Examine the technical documentation to ensure that the manufacturer has adequate means to ensure homogeneous manufacturing.

5.1 The body shall draw up an assessment report to take into account the activities carried out in accordance with paragraph 4 and its results. Without prejudice to point 1.h of Annex II, the body shall publish the content of this report only, in whole or in part, with the agreement of the manufacturer.

5.2 Where the technical design complies with the metrological regulatory requirements applicable to the measuring instrument, the body shall provide the manufacturer with a model examination certificate, depending on the European legislative field or national. The certificate shall contain the name and address of the manufacturer and, where appropriate, his authorised representative, the conclusions of the examination, the conditions of validity and the data necessary for the identification of the instrument. One or more Annexes may be attached to the certificate.

The certificate and its annexes shall contain all relevant information for the assessment of conformity and control in service. In particular, in order to allow the conformity assessment of the instruments manufactured with the model examined with regard to the reproducibility of their metrological results, when properly adjusted using the means appropriate, the content will include:

a) The metrological characteristics of the instrument model.

(b) The measures required to ensure the integrity of the instruments, such as sealing, identification of the software and others.

c) Information on other elements necessary for the identification of the instruments and to check their external visual conformity with the model.

d) Where appropriate, any specific information required to verify the characteristics of the manufactured instruments.

e) In the case of a subset, all information necessary to ensure compatibility with other subsets or measuring instruments.

The certificate shall be valid for 10 years from the date of its issuance, and may be renewed for periods of equal duration thereafter.

5.3 The body shall draw up an assessment report and keep it at the disposal of the competent public administration which has designated it.

6. The manufacturer shall inform the body which maintains the technical documentation relating to the model examination certificate of any modification of the instrument which may affect the conformity of the instrument with the essential requirements or the certificate validity conditions. Such modifications require additional approval in addition to the original model examination certificate.

7. Each body shall immediately inform the competent Public Administration which has designated it of:

a) Model exam certificates and attached attachments.

b) The additional and modifications of the certificates already issued.

Each body shall immediately inform the competent Public Administration that it has designated it for the removal of a model examination certificate.

The body must keep the technical file with the documentation submitted by the manufacturer until the validity of the certificate expires.

8. The manufacturer shall keep a copy of the model examination certificate, its annexes and its additional documents together with the technical documentation, for a period expiring 10 years after the last measuring instrument has been manufactured.

9. The authorised representative of the manufacturer may submit the application referred to in point 3 and fulfil the obligations referred to in points 6 and 8. Where the manufacturer is not established in the European Union and where he does not have an authorised representative, the obligation to provide the technical documentation at the request of the manufacturer shall be the responsibility of the person designated by the manufacturer.

MODULE C

Statement of compliance with the internal manufacturing control based model

1. The declaration of conformity with the model based on internal manufacturing control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module and ensures and declares that the measuring instruments in question are in conformity with the model described in the model examination certificate and satisfy the relevant requirements of the applicable metrological regulation.

Manufacturing

2. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured with the model described in the model examination certificate and with the relevant requirements of the applicable metrological regulation.

Written Compliance Statement

3.1 The manufacturer shall affix the conformity marking to each measuring instrument that is in conformity with the model described in the model examination certificate and which satisfies the relevant requirements of the metrological regulation applicable.

3.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

Authorized Representative

4. The manufacturer's obligations under point 3.2 may be fulfilled by his authorised representative on his behalf and under his responsibility.

Where the manufacturer is not established in the European Union or when he has no authorised representative, the obligations under point 3.2 shall be the responsibility of the person who places the instrument on the market.

MODULE C1

Statement of conformity with the internal manufacturing control based model plus the tests performed on the product by an organism

1. The declaration of conformity with the model based on the internal manufacturing control, plus the tests carried out on the product by an organism, is the part of the conformity assessment procedure whereby the manufacturer complies with the obligations set out in this module and ensures and declares that the measuring instruments in question are in conformity with the model described in the model examination certificate and satisfy the relevant requirements of the applicable metrological regulation.

Manufacturing

2. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured with the model described in the model examination certificate and with the relevant requirements of the applicable metrological regulation.

Product control

3. A body, chosen by the manufacturer, shall carry out or carry out the checks on the product at appropriate intervals to be determined by the manufacturer, in order to verify the quality of the internal controls of the product, taking into account, inter alia, the technological complexity of the instruments and the volume of production. An appropriate sample of the finished product, taken by the body before placing on the market, shall be examined and appropriate tests shall be carried out in accordance with those described in the relevant document or documents referred to in Article 10 or equivalent tests, to check the conformity of the product with the type described in the model examination certificate and with the relevant requirements of the applicable metrological regulation. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

If a relevant number of sampling instruments does not reach an acceptable level of quality, the body shall take appropriate action.

Written Declaration of Compliance

4.1 The manufacturer shall apply the conformity marking, in accordance with the applicable legislative field and under the responsibility of the body referred to in point 3, the identification number of that body to each instrument of a measure that is in accordance with the model described in the model examination certificate and which satisfies the relevant requirements of the applicable metrological regulation.

4.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

Authorized Representative

5. The manufacturer's obligations under point 4.2 may be fulfilled by his authorised representative on his behalf and under his responsibility.

When the manufacturer is not established in the European Union, or when he has no authorised representative, the obligations under point 4.2 shall be the responsibility of the person who places the instrument on the market.

MODULE D

Statement of compliance with the model based on the quality assurance of the manufacturing process

1. The declaration of conformity with the model, based on the quality assurance of the manufacturing process, is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the This module ensures and declares that the measuring instruments in question are in conformity with the model described in the model examination certificate and satisfy the relevant requirements of the applicable metrological regulation.

Manufacturing

2. The manufacturer shall operate under an approved system of manufacturing quality management, inspection of the finished product and verification of the measuring instrument in question, in accordance with point 3 and shall be subject to monitoring as set out in point 4.

Quality Management System

3.1 The manufacturer shall submit an application for the assessment of his quality management system to a body of his/her choice.

The request will include:

a) All relevant information for the intended instrument category.

b) The documentation relating to the quality management system.

c) The technical documentation for the approved model and a copy of the model exam certificate.

3.2 The quality management system shall ensure the conformity of the instruments with the model described in the model examination certificate and with the requirements of the applicable metrological regulation.

All regulatory elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written provisions, procedures and instructions. This documentation of the quality management system shall allow for a consistent interpretation of the quality management programmes, plans, manuals and records.

It will include in particular an appropriate description of:

(a) The quality objectives and organizational structure, responsibilities and competencies of the management in terms of the quality of the product.

b) The techniques of manufacturing, quality assurance and quality assurance, and the processes and systematic actions to be used.

(c) The examinations and tests to be carried out before, during and after manufacture, and the frequency thereof.

(d) The documents relating to quality management, such as inspection reports and data on tests, calibration data and rating reports of the staff involved.

e) The means to monitor the achievement of the quality of the product that is required and the effective functioning of the quality management system.

3.3 The body shall evaluate the quality management system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume that the system complies with those requirements if it complies with the relevant specifications of the national standard implementing the relevant harmonised standard, from the time its references have been published.

In addition to the experience in quality management systems, the team that will audit these will include people who have the appropriate expertise in the field of metrology and the technology of the instrument and knowledge of the relevant requirements of the applicable metrological regulation. The assessment procedure shall include an inspection visit to the premises of the manufacturer.

The decision will be notified to the manufacturer. The notification shall include the findings of the inspection and the reasoned decision concerning the assessment of the system.

3.4 The manufacturer shall undertake to fulfil the obligations arising from the approved quality management system and to maintain it in a manner that remains adequate and effective.

3.5 The manufacturer shall keep the body that has approved the quality management system informed of any planned update of the quality management system.

The body will assess the proposed modifications and decide whether the modified quality management system will continue to satisfy the requirements mentioned in point 3.2 or whether it is necessary to re-examine it; decision to the manufacturer which shall include the conclusions of the examination and the reasoned decision on the proposed modification of the system.

Monitoring under the responsibility of the notified body

4.1 The purpose of the monitoring is to ensure that the manufacturer duly complies with the obligations arising from the approved quality management system.

4.2 For inspection purposes, the manufacturer shall allow the body to enter manufacturing, inspection, testing and storage sites and shall provide it with all the necessary information, in particular:

a) The documentation of the quality management system.

(b) The documents relating to quality management, such as inspection reports and test data, calibration data and rating reports of the staff involved.

4.3 The body will carry out regular audits to ensure that the manufacturer maintains and applies the quality management system and will provide an audit report to the manufacturer.

4.4 The body may also make unexpected visits to the manufacturer. During such visits, the body may, if necessary, carry out, or carry out, tests on the product in order to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report of the visit and, if tests have been carried out, a report thereof.

Written Declaration of Compliance

5.1 The manufacturer shall affix the conformity marking and under the responsibility of the body referred to in point 3.1, the identification number of the organism to each measuring instrument according to the model described in the model examination certificate and which satisfies the relevant requirements of the applicable metrological regulation.

5.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

6. The manufacturer shall, for a period expiring 10 years after the last instrument has been manufactured, keep available to the competent public authorities:

(a) The documentation referred to in the second paragraph of point 3.1.

b) The update referred to in point 3.5, as approved.

(c) The decisions and reports of the body referred to in points 3.5, 4.3 and 4.4.

7. Each body shall periodically make available to the competent public authority which has designated it the list of approvals of quality management systems, issued or rejected, and shall immediately inform such Management of the withdrawal of an approval to a quality management system.

Authorized Representative

8. The manufacturer's obligations under points 3.1, 3.5, 5.2 and 6 may be fulfilled by his authorised representative on his behalf and under his responsibility.

MODULE D1

Statement of compliance based on quality assurance of the manufacturing process

1. The declaration of conformity based on the quality assurance of the manufacturing process is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module, and ensures and declares that the measuring instruments in question satisfy the relevant requirements of the specific application regulation.

Technical documentation

2. The manufacturer shall draw up the technical documentation in accordance with Article 9. This documentation shall permit the assessment of the conformity of the instrument with the relevant metrological regulatory requirements and shall include, to the extent relevant for such assessment, the design and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the competent public authorities for a period expiring 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall operate under an approved system of manufacturing quality management, inspection of the finished product and verification of the measuring instrument in question in accordance with point 5 and shall be subject to monitoring as set out in point 6.

Quality Management System

5.1 The manufacturer shall submit an application for the assessment of his quality management system to a body of his choice.

The request will include:

a) All relevant information for the intended instrument category.

b) The documentation relating to the quality management system.

(c) The technical documentation referred to in point 2.

5.2 The quality management system shall ensure the conformity of the instruments with the relevant requirements of the applicable metrological regulation.

All regulatory elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written provisions, procedures and instructions. This documentation of the quality management system shall allow for a consistent interpretation of the quality management programmes, plans, manuals and records.

It will include in particular an appropriate description of:

(a) The quality objectives and organizational structure, responsibilities and competencies of the management in terms of the quality of the product.

b) The manufacturing techniques, quality assurance and quality assurance, processes and systematic actions to be used.

(c) The examinations and tests to be carried out before, during and after manufacture, and the frequency thereof.

(d) The documents relating to quality management, such as inspection reports and data on tests, calibration data, rating reports of the staff involved and others.

e) The means to monitor the achievement of the quality of the product that is required and the effective functioning of the quality management system.

5.3 The body shall evaluate the quality management system to determine whether it satisfies the requirements referred to in point 5.2. It shall presume the compliance of the system with those requirements if it complies with the relevant specifications of the national standard implementing the relevant harmonised standard, from the time its references have been published.

In addition to the experience in quality management systems, the audit team shall include persons who have the appropriate expertise in the field of metrology and the technology of the instrument and knowledge of the relevant requirements of the applicable metrological regulation. The assessment procedure shall include an inspection visit to the premises of the manufacturer. The decision taken shall be notified to the manufacturer, including the findings of the inspection and the reasoned decision concerning the assessment.

5.4 The manufacturer shall undertake to fulfil the obligations arising from the approved quality management system and to maintain it in a manner that remains adequate and effective.

5.5 The manufacturer shall keep the body that has approved the quality management system regularly informed of any planned update of the quality management system.

The body will assess the proposed modifications and decide whether the modified quality management system will continue to meet the requirements mentioned in point 5.2 or whether it is necessary to re-examine it.

You will notify the manufacturer of your decision. The notification shall include the conclusions of the examination and the reasoned decision on the proposed amendment.

Monitoring under the responsibility of the body

6.1 The purpose of the monitoring is to ensure that the manufacturer duly complies with the obligations arising from the approved quality management system.

6.2 For inspection purposes, the manufacturer shall allow the body to enter manufacturing, inspection, testing and storage sites and shall provide it with all the necessary information, in particular:

a) The documentation of the quality management system.

b) The technical documentation referred to in point 2.

(c) Documents relating to quality management, such as inspection reports and test data, calibration data, staff rating reports involved, etc.

6.3 The body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality management system and shall provide a report of the quality management system to the manufacturer.

6.4 The body may also make unexpected visits to the manufacturer. During such visits the body may, if necessary, carry out, or carry out, tests on the product to check the proper functioning of the quality management system, providing the manufacturer with a report of the visit. and, if tests have been performed, a report of them.

Written Declaration of Compliance

7.1 The manufacturer shall affix the conformity marking and, under the responsibility of the body referred to in point 5.1, the identification number of the latter to each measuring instrument that satisfies the relevant requirements of the the applicable metrological regulation.

7.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

8. The manufacturer shall, for a period expiring 10 years after the last instrument has been manufactured, keep available to the competent public authorities:

(a) The documentation referred to in the second paragraph of point 5.1.

b) The update referred to in point 5.5, as approved.

(c) The decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.

9. Each body shall periodically make available to the competent public authority which has designated it the list of approvals of quality management systems, issued or rejected, and shall immediately inform such Management of the withdrawal of an approval to a quality management system.

Authorized Representative

10. The manufacturer's obligations under points 3, 5.1, 5.5, 7.2 and 8 may be fulfilled by his authorised representative on his behalf and under his responsibility.

MODULE E

Statement of compliance with the model based on quality assurance of inspection and testing of the finished product

1. The declaration of conformity with the model based on the quality assurance of the inspection and testing of the finished product is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the determine in this module and ensures and declares that the measuring instruments in question are in conformity with the model described in the model examination certificate and satisfy the relevant requirements of the applicable metrological regulation.

Manufacturing

2. The manufacturer shall operate under a quality management system approved for the inspection and testing of the finished product of the measuring instrument in question in accordance with point 3, and shall be subject to supervision in accordance with the requirements of this Regulation. set out in point 4.

Quality Management System

3.1 The manufacturer shall submit an application for the assessment of his quality management system to a body of his/her choice.

The request will include:

a) All relevant information for the intended instrument category.

b) The documentation relating to the quality management system.

c) The technical documentation for the approved model and a copy of the model exam certificate.

3.2 The quality management system shall ensure the conformity of the instruments with the model described in the model examination certificate and with the relevant requirements of the applicable metrological regulation

All regulatory elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written provisions, procedures and instructions. This documentation of the quality management system shall allow for a consistent interpretation of the quality management programmes, plans, manuals and records.

It will include in particular an appropriate description of:

(a) The quality objectives and organizational structure, responsibilities and competencies of the management in terms of the quality of the product.

(b) The examinations and tests to be carried out after manufacture.

(c) The documents relating to quality management, such as inspection reports and test data, calibration data, rating reports of the staff involved and others.

d) The means to monitor the effective functioning of the quality management system.

3.3 The body shall evaluate the quality management system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume the compliance of the system with those requirements if it complies with the relevant specifications of the national standard implementing the relevant harmonised standard, from the time its references have been published.

In addition to the experience in quality management systems, the audit team shall include persons who have the appropriate expertise in the field of metrology and the technology of the instrument and knowledge of the relevant requirements of the applicable metrological regulation. The assessment procedure shall include an inspection visit to the premises of the manufacturer. The decision shall be notified to the manufacturer, including the findings of the inspection and the reasoned decision concerning the assessment of the system.

3.4 The manufacturer shall undertake to fulfil the obligations arising from the approved quality management system and to maintain it in a manner that remains adequate and effective.

3.5 The manufacturer shall keep the body that has approved the quality management system informed of any provision for updating the quality system.

The body will assess the proposed modifications and decide whether the modified quality management system will continue to meet the requirements mentioned in point 3.2 or whether it is necessary to re-examine it.

You will notify the manufacturer of your decision. The notification shall include the findings of the inspection and the reasoned decision concerning the proposed amendment.

Monitoring under the responsibility of the body

4.1 The purpose of the monitoring is to ensure that the manufacturer duly complies with the obligations arising from the approved quality management system.

4.2 For inspection purposes, the manufacturer shall allow the body to enter manufacturing, inspection, testing and storage sites and shall provide it with all the necessary information, in particular:

a) The documentation of the quality management system.

(b) The documents relating to quality management, such as inspection reports and test data, calibration data, rating reports of the staff involved and others.

4.3 The body will carry out regular audits to ensure that the manufacturer maintains and applies the quality management system and will provide an audit report to the manufacturer.

4.4 The body may also make unexpected visits to the manufacturer. During such visits, the body may, if necessary, carry out, or carry out, tests on the product in order to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report of the visit and, if tests have been carried out, a report thereof.

Written Declaration of Compliance

5.1 The manufacturer shall affix the conformity marking and under the responsibility of the body referred to in point 3.1, the identification number of the organism to each measuring instrument that conforms to the model as described above. on the model examination certificate and satisfy the relevant requirements of the applicable metrological regulation.

5.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. This declaration shall identify the model of the instrument which is the subject of the instrument. A copy of this declaration shall be provided in accordance with each measuring instrument marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

6. The manufacturer shall, for a period expiring 10 years after the last instrument has been manufactured, keep available to the competent public authorities:

(a) The documentation referred to in the second indent of point 3.1.

b) The update referred to in the second paragraph of point 3.5, as approved.

(c) The decisions and reports of the body referred to in the last paragraph of point 3.5, point 4.3 and point 4.4.

7. Each body shall periodically make available to the competent public authority which has designated it the list of approvals of quality management systems issued, or rejected, and shall immediately inform such Management of the withdrawal of an approval to a quality management system.

Authorized Representative

8. The manufacturer's obligations under points 3.1, 3.5, 5.2 and 6 may be fulfilled by his authorised representative on his behalf and under his responsibility.

MODULE E1

Statement of conformity based on assurance of quality of inspection and on tests performed on the finished product

1. The declaration of conformity based on the quality assurance of the inspection and on the tests carried out on the finished product is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the determine in this module and ensures and declares that the measuring instruments in question satisfy the relevant requirements of the applicable metrological regulation.

Technical documentation

2. The manufacturer shall draw up the technical documentation in accordance with Article 9. The documentation shall permit the assessment of the conformity of the instrument with the relevant requirements of the applicable metrological regulation and shall include, in so far as it is relevant for such assessment, the design, manufacture and operation of the instrument. of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the competent public authorities for a period expiring 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall operate under an approved quality management system for the inspection and testing of the finished product of the measuring instrument in question in accordance with point 5, and shall be subject to supervision in accordance with as set out in point 6.

Quality Management System

5.1 The manufacturer shall submit an application for the assessment of his quality management system to a body of his choice.

The request will include:

a) All relevant information for the intended instrument category.

b) The documentation relating to the quality management system.

(c) The technical documentation referred to in point 2.

5.2 The quality management system shall ensure the conformity of the instruments with the relevant requirements of the applicable metrological regulation.

All regulatory elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written provisions, procedures and instructions. This documentation of the quality management system shall allow for a consistent interpretation of the quality management programmes, plans, manuals and records.

It will include in particular an appropriate description of:

(a) The quality objectives and organizational structure, responsibilities and competencies of the management in terms of the quality of the product.

(b) The examinations and tests to be carried out after manufacture.

(c) The documents relating to quality management, such as inspection reports and test data, calibration data, rating reports of the staff involved and others.

d) The means to monitor the effective functioning of the quality management system.

5.3 The body shall evaluate the quality management system to determine whether it satisfies the requirements referred to in point 5.2. It shall presume the compliance of the system with those requirements if it complies with the relevant specifications of the national standard implementing the relevant harmonised standard, from the time its references have been published.

In addition to the experience in quality management systems, the audit team shall include persons who have the appropriate expertise in the field of metrology and the technology of the instrument and knowledge of the relevant requirements of the applicable metrological regulation. The assessment procedure shall include an inspection visit to the premises of the manufacturer. The decision shall be notified to the manufacturer, including the findings of the inspection and the reasoned decision concerning the assessment of the system.

5.4 The manufacturer shall undertake to fulfil the obligations arising from the approved quality management system and to maintain it in a manner that remains adequate and effective.

5.5 The manufacturer shall keep the body that has approved the quality management system informed of any forecast to update the quality system.

The body will assess the proposed modifications and decide whether the modified quality management system will continue to meet the requirements mentioned in point 5.2 or whether it is necessary to re-examine it.

You will notify the manufacturer of your decision. The notification shall include the findings of the inspection and the reasoned decision concerning the proposed amendment.

Monitoring under the responsibility of the body

6.1 The purpose of the monitoring is to ensure that the manufacturer duly complies with the obligations arising from the approved quality management system.

6.2 For inspection purposes, the manufacturer shall allow the body to enter manufacturing, inspection, testing and storage sites and shall provide it with all the necessary information, in particular:

a) The documentation of the quality management system.

b) The technical documentation referred to in point 2.

(c) The documents relating to quality management, such as inspection reports and test data, calibration data, rating reports of the staff involved and others.

6.3 The body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality management system and shall provide an audit report to the manufacturer.

6.4 The body may also make unexpected visits to the manufacturer. During such visits the body may, if necessary, carry out, or carry out, tests on the product to check the proper functioning of the quality management system, providing the manufacturer with a report of the visit. and, if tests have been carried out, a report thereof.

Written Declaration of Compliance

7.1 The manufacturer shall affix the conformity marking and under the responsibility of the body referred to in point 5.1, the identification number of the organism to each measuring instrument that satisfies the relevant requirements of the applicable metrological regulation.

7.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

8. The manufacturer shall, for a period expiring 10 years after the last instrument has been manufactured, keep available to the competent public authorities:

(a) The documentation referred to in the second paragraph of point 5.1.

b) The update referred to in point 5.5, as approved.

(c) The decisions and reports of the body referred to in points 5.5, 6.3 and 6.4.

9. Each body shall periodically make available to the competent public authority which has designated it the list of approvals of quality management systems issued, or rejected, and shall immediately inform such Management of the withdrawal of an approval to a quality management system.

Authorized Representative

10. The manufacturer's obligations under points 3, 5.1, 5.5, 7.2 and 8 may be fulfilled by his authorised representative on his behalf and under his responsibility.

MODULE F

Statement of compliance with the product verification-based model

1. The declaration of conformity with the model based on the verification of the product is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module and ensures and declares that the measuring instruments which comply with the provisions of paragraph 3 are in conformity with the model described in the model examination certificate and satisfy the relevant requirements of the applicable metrological regulation.

Manufacturing

2. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured with the approved model described in the model examination certificate and with the relevant requirements of the metrological regulation. applicable.

Verification

3. A body chosen by the manufacturer shall carry out, or carry out, the appropriate examinations and tests to verify the conformity of the instruments with the model described in the model examination certificate and with the relevant requirements of the applicable metrological regulation.

Tests and tests to check conformity with the metrological requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of each instrument as specified in point 4 or by means of the examination and testing of the instruments on a statistical basis as specified in point 5.

4. Verification of compliance with metrological requirements by examination and testing of each instrument.

4.1 All instruments shall be individually examined and shall be subject to appropriate tests as set out in the relevant documents referred to in Article 10, or equivalent tests, in order to verify their compliance with the metrological requirements applicable to them. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

4.2 The body shall issue a certificate of conformity concerning the examinations and tests carried out, and shall apply its identification number to each approved instrument or make it applied under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the competent public administrations for a period ending ten years after the certification of the instrument.

5. Statistical verification of compliance with metrological requirements.

5.1 The manufacturer must have taken all necessary steps to ensure that the manufacturing process ensures the homogeneity of each batch manufactured and must submit the instruments in homogeneous batches for verification.

5.2 A sample of each batch shall be randomly selected in accordance with the provisions of paragraph 5.3. All the instruments in the sample shall be individually examined and shall be subjected to appropriate tests as laid down in the relevant documents referred to in Article 10 or equivalent tests, in order to establish their conformity with the metrological requirements that apply to them and determine whether the batch is accepted or rejected. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

5.3 The statistical procedure must meet the following requirements:

Statistical control will be based on attributes. The sampling system shall ensure:

a) A quality level that corresponds to a 95% probability of acceptance, with a percentage of non-compliance less than 1%.

(b) A limit quality corresponding to a 5% probability of acceptance, with a percentage of non-compliance less than 7%.

5.4 If a batch is accepted, all the instruments in the batch are approved, except for those sample instruments that have not successfully completed the tests.

The body shall issue a certificate of conformity concerning the examinations and tests carried out, and shall apply its identification number to each approved instrument or make it applied under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the competent public administrations for a period ending ten years after the certification of the instrument.

5.5 If a batch is rejected, the body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots, the body may suspend statistical verification and take appropriate action.

Written Declaration of Compliance

6.1 The manufacturer shall affix the conformity marking to each measuring instrument that conforms to the approved model and satisfies the relevant requirements of the applicable metrological regulation.

6.2 For each instrument model, a declaration of conformity is required which must be available to the competent public authorities for 10 years after the last instrument has been manufactured. It should identify the instrument model to which it refers.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

If agreed by the body referred to in point 3, the manufacturer shall also apply, under the responsibility of the body, the identification number of that body.

7. The manufacturer may, if agreed by the body and under his responsibility, apply the body's identification number to the measuring instruments during the manufacturing process.

Authorized Representative

8. The manufacturer's obligations may be fulfilled by his authorised representative on his behalf and under his responsibility, with the exception of the obligations contained in points 2 and 5.1.

MODULE F1

Compliance Statement based on product verification

1. The declaration of conformity based on the verification of the product is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module and ensures and declares that the measuring instruments that comply with the provisions of point 5 satisfy the relevant requirements of the applicable metrological regulation.

Technical documentation

2. The manufacturer shall draw up the technical documentation in accordance with Article 9. The documentation shall permit the assessment of the conformity of the instrument with the relevant requirements of the applicable metrological regulation, including, to the extent that it is relevant for such assessment, design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of the competent public authorities for a period expiring 10 years after the last instrument has been manufactured.

Manufacturing

4. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured with the relevant requirements of the applicable metrological regulation.

Verification

5. A body chosen by the manufacturer shall carry out appropriate examinations and tests, or shall carry out them, in order to verify the conformity of the instruments with the relevant requirements of the applicable metrological regulation.

Tests and tests to check conformity with the metrological requirements shall be carried out, at the manufacturer's option, by examination and testing of each instrument as specified in paragraph 6, or by examination. and test the instruments on a statistical basis as specified in point 7.

6. Verification of compliance with metrological requirements by examination and testing of each instrument.

6.1 All instruments shall be individually examined and shall be subjected to appropriate tests as set out in the relevant documents referred to in Article 10 or equivalent tests, in order to verify their conformity. with the metrological requirements applicable to them. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

6.2 The body shall issue a certificate of conformity concerning the examinations and tests carried out and shall apply its identification number to each approved instrument or make it applied under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the competent public administrations for a period ending ten years after the certification of the instrument.

7. Statistical verification of compliance with metrological requirements.

7.1 The manufacturer must have taken all necessary steps to ensure that the manufacturing process ensures the homogeneity of each batch manufactured and must submit the instruments in homogeneous batches for verification.

7.2 A sample of each batch shall be randomly selected in accordance with paragraph 7.3.All the instruments in the sample shall be individually examined and subjected to appropriate tests as set out in the Annex. relevant documents referred to in Article 10 or equivalent tests, in order to establish their conformity with the metrological requirements applicable to them and to determine whether the batch is accepted or rejected. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

7.3 The statistical procedure must meet the following requirements:

Statistical control will be based on attributes. The sampling system shall ensure:

a) A quality level that corresponds to a 95% probability of acceptance, with a percentage of non-compliance less than 1%.

(b) A limit quality corresponding to a 5% probability of acceptance, with a percentage of non-compliance less than 7%.

7.4 If a batch is accepted, all the instruments of the batch are approved, with the exception of those sample instruments that have not successfully completed the tests.

The body shall issue a certificate of conformity concerning the examinations and tests carried out and shall apply its identification number to each approved instrument or make it applied under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the competent public administrations for a period expiring ten years after the certification of the instrument.

7.5 If a batch is rejected, the body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots, the body may suspend statistical verification and take appropriate action.

Written Declaration of Compliance

8.1 The manufacturer shall apply the conformity marking to each measuring instrument that satisfies the relevant requirements of the applicable metrological regulation.

8.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

If agreed by the body referred to in point 5, the manufacturer shall also apply, under the responsibility of the body, the identification number of that body.

9. The manufacturer may, if agreed by the body and under his responsibility, apply the body's identification number to the measuring instruments during the manufacturing process.

Authorized Representative

10. The manufacturer's obligations may be fulfilled by his authorised representative on his behalf and under his responsibility, with the exception of the obligations contained in points 4 and 7.1.

MODULE G

Compliance statement based on unit verification

1. The conformity assessment based on the unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module and ensures and declares that an instrument in accordance with the provisions of point 4, it complies with the relevant requirements of the applicable metrological regulation.

Technical documentation

2. The manufacturer shall draw up the technical documentation in accordance with Article 9 and make it available to the body referred to in point 4. The technical documentation shall permit the assessment of the conformity of the instrument with the relevant requirements of the applicable metrological regulation and to the extent that it is relevant for such assessment, including design, manufacturing and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the competent public administrations for a period of 10 years.

Manufacturing

3. The manufacturer shall take all necessary measures to ensure the conformity of the manufactured instrument with the relevant requirements of the applicable metrological regulation.

Verification

4. A body chosen by the manufacturer shall carry out, or carry out, the appropriate examinations and tests as laid down in the relevant documents referred to in Article 10 or equivalent tests, in order to verify the conformity of the instrument with the relevant requirements of the applicable metrological regulation. In the absence of a relevant regulatory document, the body concerned shall decide on the appropriate tests to be carried out.

The body shall issue a certificate of conformity concerning the examinations and tests carried out, and shall apply its identification number to the approved instrument, or make it applied under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the competent public administrations for a period expiring ten years after the certification of the instrument.

Written Declaration of Compliance

5.1 The manufacturer shall affix the conformity marking and under the responsibility of the body referred to in point 4, the identification number of that body to any measuring instrument that satisfies the relevant requirements of the applicable metrological regulation.

5.2 A declaration of conformity shall be drawn up which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the instrument has been manufactured. That declaration shall identify the instrument which is the subject of the instrument.

A copy of the declaration will be provided with the measuring instrument.

Authorized Representative

6. The manufacturer's obligations under point 2 and in paragraph 3 of paragraph 4 may be fulfilled by his authorised representative on his behalf and under his responsibility.

MODULE H

Statement of compliance based on total quality assurance

1. The declaration of conformity based on the total quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module and ensures and declares that the measuring instruments in question satisfy the relevant requirements of the applicable metrological regulation.

Manufacturing

2. The manufacturer shall operate under an approved quality management system for the design, manufacture and inspection of the finished product and for the performance of the tests of the measuring instrument in question in accordance with the provisions of the Point 3, and shall be subject to supervision in accordance with point 4.

Quality Management System

3.1 The manufacturer shall submit an application for the assessment of his quality management system to a body of his/her choice.

The request will include:

a) All relevant information for the intended instrument category.

b) The documentation relating to the quality management system.

3.2 The quality management system shall ensure the conformity of the instruments with the relevant requirements of the applicable metrological regulation.

All regulatory elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written provisions, procedures and instructions. This documentation of the quality management system shall allow for a consistent interpretation of the quality management programmes, plans, manuals and records. It shall include in particular an appropriate description of:

(a) The quality objectives and organizational structure, responsibilities and competencies of the management in terms of product design and quality.

(b) The technical design specifications to be applied, including the rules, and, where the relevant documents referred to in Article 10 are not fully applied, the means to be used to ensure the compliance with the essential requirements of the metrological regulation applicable to the instruments.

c) Design control and design verification techniques, the systematic processes and actions that will be used to design the instruments belonging to the instrument category in question.

d) The corresponding techniques of manufacturing, quality management and quality assurance to be used, as well as the systematic processes and actions to be followed.

e) The examinations and tests to be carried out before, during and after manufacture, and the frequency thereof.

f) The documents relating to quality management, such as inspection reports and test data, calibration data, rating reports of the staff involved and others.

g) The means to control the achievement of the required quality of design and product and the effective functioning of the quality management system.

3.3 The body shall evaluate the quality management system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume the conformity of the system to those requirements if it complies with the relevant specifications of the national standard implementing the relevant harmonised standard, from the time its references have been published in the Bulletin State Officer.

In addition to the experience in quality management systems, the audit team shall include persons who have the appropriate expertise in the field of metrology and the technology of the instrument and knowledge of the relevant requirements of the applicable metrological regulation. The assessment procedure shall include an inspection visit to the premises of the manufacturer.

The decision will be notified to the manufacturer including the findings of the inspection and the reasoned decision regarding the assessment of the system.

3.4 The manufacturer shall undertake to fulfil the obligations arising from the approved quality management system and to maintain it in a manner that remains adequate and effective.

3.5 The manufacturer shall keep the body that has approved the quality management system informed of any planned update of the quality management system.

The body will assess the proposed modifications and decide whether the modified quality management system continues to meet the requirements mentioned in point 3.2 or whether it is necessary to re-examine it.

You will notify your decision to the manufacturer including the findings of the inspection and the reasoned decision regarding the proposed modification.

Monitoring under the responsibility of the body

4.1 The purpose of monitoring is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality management system.

4.2 For inspection purposes, the manufacturer shall allow the body to enter manufacturing, inspection, testing and storage sites and shall provide it with all the necessary information, in particular:

a) The documentation relating to the quality management system.

(b) The documents relating to quality management as provided for in the design part of the quality management system, for example the results of analyses, calculations, tests and others.

(c) the documents relating to the management of the quality in accordance with the provisions of the part concerning the manufacture in the quality management system, for example, inspection reports and test data, data on calibration and rating reports of the staff involved.

4.3 The body will carry out regular audits to ensure that the manufacturer maintains and applies the quality management system and will provide an audit report to the manufacturer.

4.4 In addition, the body may carry out inspection visits to the manufacturer without prior notice. During such visits the body may, if necessary, carry out tests on the product or make them carry out under its responsibility, to check the proper functioning of the quality management system and provide the manufacturer a report of the visit and if tests have been carried out, a report of the same.

Written Declaration of Compliance

5.1 The manufacturer shall apply to each measuring instrument that satisfies the relevant requirements of the applicable metrological regulation, the conformity marking and under the responsibility of the body referred to in point 3.1, the identification number of that body.

5.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

6. The manufacturer shall, for a period expiring 10 years after the last instrument has been manufactured, keep available to the competent public authorities:

(a) The documentation relating to the quality management system referred to in the second indent of point 3.1.

b) The update referred to in point 3.5, as approved.

(c) The decisions and reports of the body referred to in points 3.5, 4.3 and 4.4.

7. Each body shall periodically make available to the competent public authority which has designated it the list of approvals of quality management systems issued, or rejected, and shall immediately inform such Management of the withdrawal of an approval to a quality management system.

Authorized Representative

8. The manufacturer's obligations under points 3.1, 3.5, 5.2 and 6 may be fulfilled by his authorised representative on his behalf and under his responsibility.

MODULE H1

Statement of compliance based on total quality assurance plus design review

1. The declaration of conformity based on the total quality assurance plus the design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in this module and ensures and declares that the measuring instruments in question satisfy the relevant requirements of the applicable metrological regulation

Manufacturing

2. The manufacturer shall operate under an approved quality management system for the design, manufacture and inspection of the finished product and for the performance of the tests of the measuring instrument in question in accordance with the provisions of the Point 3 and shall be subject to supervision in accordance with point 5. The adequacy of the technical design of the measuring instrument shall have been examined in accordance with the provisions of point 4.

Quality Management System

3.1 The manufacturer shall submit an application for the assessment of his quality management system to a body of his/her choice.

The request will include:

a) All relevant information for the intended instrument category.

b) The documentation relating to the quality management system.

3.2 The quality management system shall ensure the conformity of the instruments with the relevant requirements of the applicable metrological regulation.

All regulatory elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written provisions, procedures and instructions. This documentation of the quality management system shall allow for a consistent interpretation of the quality management programmes, plans, manuals and records. It shall include in particular an appropriate description of:

(a) The quality objectives and organizational structure, responsibilities and competencies of the management in terms of product design and quality.

(b) The technical design specifications to be applied, including the rules, and, where the relevant documents referred to in Article 10 are not fully applied, the means to be used to ensure the compliance with the relevant requirements of the metrological regulation applicable to the instruments.

c) Design control and design verification techniques, the systematic processes and actions that will be used to design the instruments belonging to the instrument category in question.

d) The corresponding techniques of manufacturing, quality management and quality assurance to be used, as well as the systematic processes and actions to be followed.

e) The examinations and tests to be carried out before, during and after manufacture, and the frequency thereof.

f) The documents relating to quality management, such as inspection reports and test data, calibration data and rating reports of the staff involved.

g) The means to control the achievement of the required quality of design and product and the effective functioning of the quality management system.

3.3 The body shall evaluate the quality management system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume the conformity of the system to those requirements if it complies with the relevant specifications of the national standard implementing the relevant harmonised standard, from the time its references have been published in the Bulletin State Officer.

In addition to the experience in quality management systems, the audit team shall include persons who have the appropriate expertise in the field of metrology and the technology of the instrument and knowledge of the applicable requirements of the applicable metrological regulation. The assessment procedure shall include an inspection visit to the premises of the manufacturer.

The decision will be notified to the manufacturer, including the findings of the inspection and the reasoned decision regarding the evaluation of the system.

3.4 The manufacturer shall undertake to fulfil the obligations arising from the approved quality management system and to maintain it in a manner that remains adequate and effective.

3.5 The manufacturer shall keep the body that has approved the quality management system informed of any planned update of the quality management system.

The body will assess the proposed modifications and decide whether the modified quality management system continues to meet the requirements mentioned in point 3.2 or whether it is necessary to re-examine it.

You will notify your decision to the manufacturer, including the findings of the inspection and the reasoned decision regarding the proposed modification.

3.6 Each body shall periodically make available to the competent Public Administration the list of approvals of quality management systems issued, or rejected, and shall immediately inform such Administration of the withdrawal of an approval to a quality management system.

Design Review

4.1 The manufacturer shall submit an application for examination of the design to the body referred to in point 3.1

4.2 The application shall allow for the understanding of the design, manufacture and operation of the instrument, and shall allow the assessment of compliance with the relevant requirements of the applicable metrological regulation. Such request shall include:

a) The name and address of the manufacturer.

b) A written statement that the same application has not been filed with any other body.

(c) The technical documentation described in Article 5. This documentation shall permit the assessment of the conformity of the instrument with the relevant requirements of the applicable metrological regulation, including to the extent that it is relevant for such assessment, design and operation of the instrument. instrument.

d) Tests that support the adequacy of the technical design. Such supporting evidence shall mention any rule that has been applied, in particular where the relevant documents referred to in Article 10 have not been fully applied and shall include, if necessary, the results of the tests. carried out by the competent laboratory of the manufacturer, or by another laboratory which has carried out the tests on its behalf and under its responsibility.

4.3 The body shall examine the application and if the design complies with the provisions of the metrological regulations applicable to the measuring instrument, it shall issue a design examination certificate to the manufacturer. The certificate shall include the name and address of the manufacturer, the conclusions of the examination, any conditions of validity and the data necessary for the identification of the approved instrument.

4.3.1 All relevant parts of the technical documentation shall be attached to the certificate.

4.3.2 The certificate, or its annexes, shall contain all the information relevant to the conformity assessment and the control in service. In particular, in order to allow the conformity assessment of the instruments manufactured with the design examined with regard to the reproducibility of their metrological results, when properly adjusted using the means appropriate. The content will include:

a) The metrological characteristics of the instrument design.

(b) The measures required to ensure the integrity of the instruments, such as sealing and identification of the software.

c) Information about other elements necessary for the identification of the instrument and to check its external conformity with the design.

d) If applicable, any specific information necessary to verify the characteristics of the manufactured instruments.

e) In the case of a subset, all information necessary to ensure compatibility with other subsets or measuring instruments.

4.3.3 The body shall draw up an assessment report and keep it at the disposal of the competent public administration which has appointed it. Without prejudice to the provisions of point 1. h of Annex II, the body shall publish the content of this report only, in whole or in part, with the agreement of the manufacturer.

The certificate shall be valid for 10 years from the date of its issuance and may be renewed for periods of equal validity thereafter.

If a design examination certificate is denied to the manufacturer, the body shall provide the detailed reasons for such a refusal.

4.4 The manufacturer shall keep the body that has issued the design examination certificate informed of any fundamental changes to the approved design. Modifications to the approved design shall be subject to additional approval by the body which issued the design examination certificate, where such modifications may affect conformity with the essential requirements and specific to the applicable metrological regulation, the conditions of validity of the certificate or the conditions required for the use of the instrument. This supplemental approval will be granted in addition to the original design exam certificate.

4.5 Each body shall periodically make available to the competent Public Administration which has designated it:

a) Design exam certificates and attached attachments.

b) The additional and modifications of the certificates already issued.

Each body shall immediately inform the competent Public Administration that it has designated it for the removal of a design examination certificate.

4.6 The manufacturer or his authorised representative shall keep a copy of the design examination certificate, its annexes and its additional documents, together with the technical documentation, for a period expiring 10 years after the date of the manufacturing of the last measuring instrument.

When the manufacturer or his authorised representative is not established in the European Union, the obligation to provide the technical documentation when requested shall be the person designated by the manufacturer.

Monitoring under the responsibility of the body

5.1 The purpose of the supervision is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality management system.

5.2 For inspection purposes, the manufacturer shall allow the body to enter design, manufacturing, inspection, testing and storage sites and shall provide it with all the necessary information, in particular:

a) The documentation relating to the quality management system.

(b) The documents relating to quality management as provided for in the design part of the quality management system, for example, the results of analyses, calculations and tests.

(c) the documents relating to the management of the quality in accordance with the provisions of the part concerning the manufacture in the quality management system, for example, inspection reports and test data, data on calibration and rating reports of the staff involved.

5.3 The body will carry out regular audits to ensure that the manufacturer maintains and applies the quality management system and will provide an audit report to the manufacturer.

5.4 In addition, the body may carry out inspection visits to the manufacturer without prior notice. During such visits, the body may, if necessary, carry out tests on the product, or carry out tests under its responsibility, in order to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report of the visit and if tests have been carried out.

Written Declaration of Compliance

6.1 The manufacturer shall apply to each measuring instrument that satisfies the relevant requirements of the applicable metrological regulation, the conformity marking and under the responsibility of the body referred to in point 3.1, the identification number of that body.

6.2 A declaration of conformity shall be drawn up for each instrument model, which shall be kept at the disposal of the competent public authorities for a period expiring 10 years after the last year of manufacture. instrument. That declaration shall identify the model of the instrument that is the subject of the instrument and the number of the design examination certificate shall be mentioned.

A copy of this declaration shall be provided in accordance with each instrument of measure marketed. However, in cases where a large number of separate instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment.

7. The manufacturer shall, for a period expiring 10 years after the last instrument has been manufactured, keep available to the competent public authorities:

(a) The documentation referred to in the second indent of point 3.1.

b) The update referred to in point 3.5, as approved.

(c) The decisions and reports of the body referred to in points 3.5, 5.3 and 5.4.

Authorized Representative

8. The manufacturer's obligations under points 3.1, 3.5, 6.2 and 7 may be fulfilled by his authorised representative on his behalf and under his responsibility.

ANNEX IV

Common essential requirements for measuring instruments

The measuring instruments must provide a high level of metrological protection so that all the parties concerned can have confidence in the outcome of the measurement, and must be designed and manufactured with a high level of protection. quality level with regard to measurement technology and the safety of measurement data.

The requirements to be met by the measuring instruments to meet the above mentioned objectives, completed, in cases where they so require, by the specific requirements for specific requirements, are set out below. instruments set out in Annexes V to XIV, detailing certain aspects of the general requirements.

The solutions adopted to meet these requirements should take into account the use of the instrument, as well as its foreseeable misuse.

Definitions

Measuring: Particular Magnitude to be measured.

Magnitude of Influence: Magnitude not being the measurement has an effect on the measurement result.

Nominal operating conditions: The nominal operating conditions are the values for the measurement and for the magnitudes of influence that shape the normal working conditions of an instrument.

Disturbance: A magnitude of value influence within the limits specified in the corresponding requirement, but outside the nominal operating conditions specified for the measuring instrument. A magnitude of influence is a disturbance when the nominal operating conditions for that magnitude of influence have not been specified.

Variation Critical Value: Critical variation value is that value for which the change in the measurement result is considered undesirable.

Materialized measure: A materialized measure is a device whose purpose is to continuously reproduce or provide, during its use, one or more known values of a particular magnitude.

Direct Selling Commercial Transaction: A business transaction is considered as a "direct sale" if the following three conditions are met:

the measurement result serves as the basis for the amount to be paid;

at least one of the parties involved in the measurement-related transaction is a consumer or any other party that needs a similar level of protection;

all parties to the transaction accept the result of the measurement at that time and place.

Climate Environments: Climate environments mean the conditions under which measuring instruments can be used. The different possibilities are set out in Table 1 of Section 1.3.1 of this Annex.

Public Service Company: You consider a utility to be a supplier of electricity, gas, thermal energy, or water.

Requirements

1. Errors allowed:

1.1 In nominal operating conditions and in the absence of disturbances, the measurement error should not exceed the maximum permissible error value (emp) specified in the relevant specific requirements for the instrument.

Unless otherwise specified in the specific Annexes relating to the instrument, the maximum permissible error shall be expressed as the bilateral value of the deviation of the true measurement value.

1.2 In nominal operating conditions and in the presence of a disturbance, the operating requirements shall be those set out in the relevant requirements for the specific instrument.

When the instrument is designed to be used in a given permanent continuous electromagnetic field, the permissible operation during the radiating electromagnetic field test, modulated in amplitude, shall not be exceed the maximum allowed error.

1.3 The manufacturer shall specify the climatic, mechanical and electromagnetic environments for which the instrument is designed, the power supply and other influence measures which may affect its accuracy, taking into account the requirements set out in the instrument-specific annexes.

1.3.1 Climate environments: The manufacturer shall specify the upper and lower temperature limit for each of the values specified in Table 1, except where otherwise indicated in the specific Annex to the instrument, and indicate whether the instrument is designed for moisture (condensation or non-condensing) and whether the intended placement for the instrument is inside or outside.

Table 1

Limit	Temperature
	30 ° C	40 ° C	55 ° C	70 ° C
Low Temperature Limit	+ 5 ° C	-10 ° C	-25 ° C	-40 ° C

1.3.2 a) Mechanical environments are classified in classes M1 to M3 as described below:

M1: This class corresponds to the instruments used in sites subjected to vibrations and minor shocks, for example, to instruments attached to light-bearing structures subjected to vibration Negligible and/or shocks transmitted by start operations or percussion, portazo, etc.

M2: This class corresponds to the instruments used in sites with significant or high vibration and shock levels, from machines or caused by the passing of vehicles in the vicinity or near to large machines, conveyor belts, etc.

M3: This class corresponds to the instruments used in sites where the level of vibration and shock is high or very high, for example, in the case of instruments installed directly on machines, tapes Carriers, etc.

b) The following magnitudes of influence in relation to mechanical environments shall be taken into account:

Vibration.

Mechanical shock.

1.3.3 (a) Electromagnetic environments are classified in classes E1, E2 or E3 as described below, unless otherwise specified in the instrument-specific annexes.

E1: This class corresponds to the instruments used in sites with electromagnetic disturbances corresponding to those that are likely to be found in residential, commercial and light industry buildings.

E2: This class corresponds to the instruments used in sites with electromagnetic disturbances corresponding to those that are likely to be found in other industrial buildings.

E3: This class corresponds to the instruments powered by the battery of a vehicle. Such instruments shall meet the requirements of class E2 and the following additional requirements:

Voltage drops caused by the activation of the internal combustion engine start-up circuits.

Transient downloads caused by disconnecting a discharged battery with the engine running.

(b) The following magnitudes of influence in relation to electromagnetic environments shall be taken into account:

Tension cuts.

Brief drops of tension.

Transitional tensions in the supply and/or signal lines.

Electrostatic downloads.

Radiofrequency Electromagnetic Fields.

Radio-frequency electromagnetic fields, driven in the supply and/or signal lines.

Voltage spikes on supply and/or signal lines.

1.3.4 Other influence measures to be taken into account when applicable are as follows:

Tension variation.

Variation of network frequency.

Magnetic fields at the power frequency.

Any other magnitude that may have a significant influence on the accuracy of the instrument.

1.4 The following points shall apply when the tests provided for in this Royal Decree are carried out.

1.4.1 Basic standards for testing and error determination: The essential requirements specified in points 1.1 and 1.2 shall be verified for each of the relevant influence measures. Unless otherwise specified in Annexes V to XIV relating to an instrument, these essential requirements shall be verified by the independent application of each of the influence measures and their effects shall be assessed by separate, keeping all other influence magnitudes relatively constant in their reference value.

The metrological tests shall be carried out during or after the application of the magnitude of influence, depending on the situation corresponding to the normal operation of the instrument at the time it is likely to be the magnitude of influence appears.

1.4.2 Ambient humidity:

According to the operating climate environment for which the instrument is designed, it may be appropriate, either the continuous wet heat test (without condensation), or the cyclic wet heat test (with condensation).

The cyclic wet heat test is suitable in cases of high condensation or when steam penetration is accelerated by the effect of breathing. In conditions of moisture without condensation, the continuous wet heat test shall be appropriate.

2. Reproducibility: The measurement of a magnitude of the same value at a different site or by a different user, provided that the other measurement conditions are the same, shall result in very similar successive measurement results. The difference between the results of the measurements shall be small if compared to the maximum permissible error.

3. Repeatability: The measurement of a magnitude of the same value under the same measurement conditions should result in very similar successive results. The difference in the measurement results shall be small when compared to the maximum permissible error.

4. Mobility and sensitivity: A measuring instrument shall be sufficiently sensitive and its mobility threshold shall be sufficiently low for the measurement task for which it has been designed.

5. Durability: A measuring instrument shall be designed in such a way as to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that its installation, maintenance and Use be appropriate and follow the manufacturer's instructions, in the environmental conditions for which it was designed.

6. Reliability: A measuring instrument shall be designed to reduce as much as possible defects that may result in an inaccurate measurement result, unless the presence of such defects is obvious.

7. Fitness:

7.1 A measuring instrument shall lack any characteristic that may favour its fraudulent use; the possibility of inadvertent improper use shall also be minimised.

7.2 A measuring instrument must be adapted to the use for which it has been designed, taking into account practical working conditions, and must not require the user to have a special skill or training to obtain a result correct measurement.

7.3 The errors of a measuring instrument, of a public service installed in flows or currents outside the controlled field, shall not have an undue bias.

7.4 When a measuring instrument is designed to measure measurement values that remain constant over time, the measuring instrument shall be insensitive to small fluctuations in the value of the measurement, or must act accordingly.

7.5 A measuring instrument shall be resistant and constructed with materials appropriate to the conditions for which it has been designed.

7.6 The measuring instrument shall be designed in such a way as to enable the measurement activities to be controlled if the instrument has been marketed and started to be used. If necessary, as part of the instrument, the special equipment or programme to be checked shall be included. The test procedure shall be described in the operating manual.

When a measuring instrument includes a programme containing other functions in addition to the measurement function, the programme indispensable for metrological characteristics shall be identifiable and shall not be influenced beyond the acceptable to the associated program.

8. Protection against corruption:

8.1 The metrological characteristics of a measuring instrument shall not be altered, beyond the permissible, by the connection to another device, by any characteristic of the connected device, or by any device communicating remotely with the measuring instrument.

8.2 Any component of the physical media that is critical to the metrological characteristics must be designed so that it can be protected. The planned safety measures should include evidence of possible interventions.

8.3 Any logical support that is critical to the metrological characteristics must be identified as such and must be protected.

The identification of the logical support must be provided in a simple manner by the measuring instrument.

A clear evidence of possible interventions should be available over a reasonable period of time.

8.4 The measurement data, the software necessary for the characteristics of the measurements and the parameters of metrological importance stored or transmitted shall be adequately protected against the accidental or intentional corruption.

8.5 In the case of measuring instruments of public service undertakings, the indicator of the total quantity supplied or the indicators from which the total quantity supplied may be extracted, which serve as a total reference or partial for payment may not be set to zero during use.

9. Information to be included in the instrument and accompany it:

9.1 The following data shall be included in a measuring instrument:

Brand or name of the manufacturer.

Information about its accuracy.

and where applicable,

Required data about the conditions of use. Maximum scope.

Measure field.

Identity Marking.

Number of the model EC exam certificate, or the EC design examination certificate.

Information on whether other additional devices, which provide metrological results, comply with or do not comply with the provisions of this Royal Decree on legal metrological control.

9.2 Instruments whose dimensions are too small or whose composition is too sensitive for the appropriate information to be included must bear the necessary information in their packaging, if any, and in the documents required by the provisions set out in this Royal Decree.

9.3 The measuring instrument shall be accompanied by information on its operation, unless this is unnecessary due to the simplicity of the instrument. The information will be easy to understand and should include, if applicable:

The nominal operating conditions.

The mechanical and electromagnetic environment classes.

The upper and lower temperature limit; whether or not condensation is possible, inner or outer placement.

The instructions for installation, maintenance, repairs, and allowed settings.

The instructions for proper handling and special operating conditions.

Compatibility conditions with interfaces, subsets, or measurement instruments.

9.4 The groups of identical measuring instruments used in the same place, or measuring instruments used to measure in public services do not necessarily require individual instruction manuals.

9.5 Unless otherwise indicated in a specific annex relative to the instrument, the value of the step for a measured value must be in the form 1x10 ", 2x10", or 5x10 ^, where n is an integer or zero. The unit of measure or its symbol must appear next to the numeric value.

9.6 The materialised measures shall be marked with a nominal scale or value, where the unit of measurement used shall be shown.

9.7 The units of measurement used and their symbols will be in accordance with the provisions laid down in Royal Decree 1317/1989 of 27 October 1989 and their amendment to Royal Decree 1737/1989 of 20 November 1989 concerning the legal units of measurement and their symbols.

9.8 All markings and inscriptions provided for in the requirements must be clear, indelible, unambiguous and non-transferable.

10. Result indication:

10.1 The indication of the result must be performed by a visual presentation or printed document.

10.2 The indication of any result must be clear and unambiguous and must be accompanied by the marks and inscriptions necessary to inform the user of the meaning of the result. The presented result should be easy to read under normal conditions of use. Other indications may be provided, provided that they do not lead to confusion with the metrologically controlled indications.

10.3 In the case of printed or recorded results, printing or recording must also be easily legible and indelible.

10.4 The measuring instruments for commercial direct sales transactions should be designed to present the result of the measurement to both parties involved in the transaction when they are installed for this purpose. Where this is essential, in the case of direct sales, any proof of payment provided to the consumer by an ancillary device which does not comply with the relevant requirements of the Royal Decree shall bear the appropriate restrictive information.

10.5 Regardless of whether or not they can be read at a distance, measuring instruments intended for measurement in public services must be provided in all cases of a controlled metrologically accessible indicator without tools for the consumer. The reading of this indicator will be the measurement result that will serve as a basis for the amount to be paid.

11. Other data processing to complete the business transaction:

11.1 The measuring instruments, different from those used in public services, shall record in a durable medium the results of the measurement together with the identification information of the particular transaction when:

the measurement is not repeatable and

the measuring instrument is typically designed for use in the absence of one of the parties involved in the transaction.

11.2 In addition, when the measurement is completed, it must be available whenever a durable test of the result of the measurement and of the information necessary to identify the transaction is requested.

12. Conformity assessment: The measuring instruments shall be designed in such a way as to enable them to easily assess their conformity with the requirements set out in this Royal Decree or in their national specific regulation.

ANNEX V

Specific requirements specific to water meters

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 of this Royal Decree, shall apply to the water for the measurement of volumes of clean, cold or hot water for residential, commercial or light industry use.

Definitions

Water meter: An instrument designed to measure, memorize and indicate the volume, in the measurement conditions, of the water distribution that passes through the measurement transducer.

Minimum water flow (Q₁): The smallest water flow with which the water meter provides indications that meet the maximum permissible error requirements.

Transition Water Flow (Q₂): The transition water flow rate is the value of the water flow that is between the minimum and permanent water flow rate and where the water flow rate is divided into two zones, the "upper zone" and the "lower zone". Each zone corresponds to a characteristic maximum allowed error.

Permanent Water Flow (Q₃): This is the highest water flow with which the water meter can function satisfactorily under normal conditions, i.e. under steady-flow conditions or intermittent.

Overload water flow (Q₄): The overhead water flow is the highest flow rate with which the counter can function successfully for a short period of time without deterioration.

Specific requirements

Nominal operating conditions: The manufacturer shall specify the nominal operating conditions of the instrument, in particular:

1. The water flow range: The water flow range values shall meet the following conditions:

Q₃/Q₁ ≥ 10

Q₂/Q₁ = 1.6

Q₄/Q₃ = 1.25

For a period of 5 years from the adoption of this Order the Q₂/Q ratio₁ may be: 1.5; 2.5; 4 or 6.3.

2. The temperature range of water: The values of the water temperature range must satisfy the following conditions:

of 0,1 ° C at a temperature of at least 30 ° C, or

30 ° C to a temperature of at least 90 ° C.

The counter may be designed to work with both intervals.

3. The relative pressure range of the water, which will go from 0.3 bar to a pressure of at least 10 bar to Q₃.

4. For electrical power: The nominal value of the power voltage in alternating current and/or the limits of the current power supply voltage.

Maximum error allowed:

5. The maximum allowed, positive, or negative error on the volumes supplied under flow rates between the transition flow (Q₂) (inclusive) and the overhead flow (Q₄) is:

2% for water with a temperature ≤ 30 ° C,

3% for water with a temperature > 30 ° C.

6. The maximum allowed, positive or negative error on volumes supplied under flow rates between the minimum flow rate (Q₁) and the transition water flow (Q₂) (excluding) is 5% regardless of the water temperature.

Allowed effect of perturbations:

7.1 Electromagnetic Immunity:

7.1.1 The effect of an electromagnetic disturbance on a water meter shall be such that:

the change in the measurement result does not exceed the critical change value defined in paragraph 7.1.3, or

the indication of the result of the measurement cannot be interpreted as a valid result, such as that of a momentary variation that should not be interpreted, memorized, or transmitted as a result of the measurement.

7.1.2 After an electromagnetic disturbance, the water meter must:

recover the operating capacity within the maximum allowed error,

preserve all measurement functions in perfect condition, and

allow the recovery of all measurement data present just before the disturbance appeared.

7.1.3 The change critical value is the smallest of the following two values:

The volume corresponding to half the magnitude of the maximum error allowed in the upper zone over the measured volume.

The volume corresponding to the maximum allowed error on the volume corresponding to one minute at the permanent water flow (Q₃).

7.2 Durability: After an appropriate test has been performed that takes into account the time period estimated by the manufacturer, the following criteria must be met:

7.2.1 The variation of the measurement result after the durability test when compared to the initial measurement shall not exceed:

3% of the volume measured between Q₁ included and Q₂ excluded;

1.5% of the volume measured between Q₂ included and Q₄ included.

7.2.2 The volume indication error measured after the durability test cannot be exceeded:

± 6% of the volume measured between Q₁ included and Q₂ excluded;

± 2,5% of the volume measured between Q₂ included and Q₄ included in counters intended to measure water at temperatures between 0.1 ° C and 30 ° C;

± 3.5% of the volume measured between Q₂ included and Q₄ included in counters intended to measure water at temperatures between 30 ° C and 90 ° C.

Fitness:

8.1 The counter must be able to be installed to operate in any position, unless clearly stated otherwise.

8.2 The manufacturer shall specify whether the counter is designed to measure the reverse flow. In such a case, the volume of the reverse flow must either subtract from the accumulated volume or be recorded separately. Both the normal and the reverse flow shall be applied the same maximum permissible error.

Water meters that are not designed to measure the reverse flow will either impede the reverse flow or resist an accidental reverse flow without altering or deteriorating their metrological properties.

Measurement units:

9. The measured volume shall be indicated in cubic metres, the symbol of which is m³.

Put into service:

10. The competent Public Administration shall ensure that the requirements of points 1, 2 and 3 are determined by the distributor or by the person legally authorised to install the counter, so that it is appropriate for measuring the with accuracy of expected or foreseeable consumption.

Conformity Assessment: The conformity assessment procedures referred to in Article 6, among which the manufacturer may choose are:

B + F or B + D or H1.

ANNEX VI

Essential requirements specific to gas counters and volumetric conversion devices

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 of this Royal Decree, shall apply to the gas and the volumetric conversion devices that are defined below for residential, commercial and light industry use.

Definitions

Gas counter: Instrument designed for measurement, memorization and indication of the amount of fuel gas (volume or mass) that has passed through it.

Conversion Device: Device installed on a gas counter that automatically converts the measured quantity into distribution conditions to an amount in base conditions.

Minimum flow rate (Q_min): The lowest flow rate at which the gas meter provides indications respecting the maximum error allowed.

Maximum flow (Q_max): The highest flow rate with which the gas counter provides indications respecting the maximum permissible error requirements.

Transition Flow (Q_t): The transition flow rate is the value of the flow rate that is between the minimum and maximum flow rate and where the flow rate is divided into two zones, the "top zone" and the "bottom zone". Each zone corresponds to a characteristic maximum allowed error.

Overload (Q_r): The overhead flow rate is the highest flow rate with which the counter can function successfully for a short period of time without deterioration.

Base Conditions: The specific conditions to which the amount of measured fluid is converted.

PART 1

Specific requirements for gas counters

1. Nominal operating conditions: The manufacturer shall specify the nominal operating conditions of the gas meter, taking into account:

1.1 The gas flow range shall meet at least the following conditions:

1.2

accuracy class	Qmax/Qmin	Qmax /Qt	Qr/Qmax
1.5	≥ 150	1.2
	1.2
1.0	≥ 1.0	≥ 5	1.2

1.2 The gas temperature range, with a minimum of 40 ° C.

1.3 Fuel gas conditions.

The instrument must be designed for the range of gases and supply pressures in the country of destination. The manufacturer shall specify in particular:

the gas family or group;

the maximum operating pressure.

1.4 A minimum temperature range of 50 ° C for the climate environment.

1.5 The nominal value of the supply of alternating voltage and/or the limits of the supply of continuous voltage.

2. Maximum allowed errors:

2.1 Gas counter indicating the volume under measurement conditions or the mass:

Table 1

accuracy class	1.5	1.0
min ≤ Q ≤ Qt	3%	2%
t ≤ Q ≤ Qmax	1.5%	1%

When the errors between Q_t and Q_max have all the same sign, they must not exceed 1% for the accuracy class 1.5 and 0.5% for the accuracy class 1.0.

2.2 In the case of a gas counter with temperature conversion that only indicates the converted volume, the maximum permissible error of the counter shall be increased by 0,5% in an interval of 30 ° C which shall be extended Symmetric around the temperature indicated by the manufacturer, which shall be between 15 ° C and 25 ° C. Outside this range, an additional 0.5% increase in each 10 ° C interval is permitted.

3. Permitted effect of disturbances:

3.1 Electromagnetic Immunity:

3.1.1 The effect of an electromagnetic disturbance on the gas meter or the volumetric conversion device shall be such that:

the change in the measurement result does not exceed the critical change value defined in point 3.1.3, or

the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a momentary variation that should not be interpreted, memorized, or transmitted as a result of the measurement.

3.1.2 After a disturbance, the gas meter shall:

recover the operating capacity within the allowed error margin, and

preserve all measurement functions in perfect condition, and

allow all measurement data present to be recovered just before the disturbance appears.

3.1.3 The change critical value is the smallest of the following two values:

The amount corresponding to half the magnitude of the maximum error allowed in the upper zone over the measured volume.

The amount corresponding to the maximum allowable error on the amount corresponding to a minute of maximum flow.

3.2 Effect of flow disturbances upstream or downstream: In the installation conditions specified by the manufacturer, the effect of flow disturbances shall not exceed one third of the maximum error allowed.

4. Durability: After an appropriate test has been carried out to take into account the time period estimated by the manufacturer, the following criteria must be met.

4.1 Accuracy Class 1.5 counters:

4.1.1 The variation of the measurement result after the durability test in the range of flow rates of Q_t to Q_max shall not exceed by more than 2% the result of the initial measurement.

4.1.2 The indication error after the durability test shall not exceed twice the maximum error allowed in accordance with paragraph 2.

4.2 Accuracy Class 1.0 counters:

4.2.1 The variation of the measurement result after the durability test when compared to the result of the initial measure shall not exceed one third of the maximum error allowed in accordance with paragraph 2.

4.2.2 The indication error after the durability test shall not exceed the maximum error allowed in accordance with paragraph 2.

5. Fitness:

5.1 A gas meter connected to the electrical grid (alternating or continuous) shall be equipped with a device for the supply of emergency electricity or other means to ensure the safeguarding of all functions measurement in case of failure of the main electrical power source.

5.2 A specific energy source must have a life span of at least 5 years. A warning must appear after 90% of your life span has elapsed.

5.3 An indicator device must have a sufficient number of digits to ensure that the amount that passes for 8,000 hours with Q_max does not make the digits return to their initial value.

5.4 The gas meter shall be installed in such a way as to operate in any position indicated by the manufacturer in its installation manual.

5.5 The gas meter shall have a test element that will allow for testing within a reasonable time.

5.6 The gas meter shall respect the maximum error allowed in any direction of flow or only in the direction of flow, when clearly indicated.

6. Units: The measured quantity shall be indicated in cubic metres, symbol m₃ or in kilograms, symbol kg.

PART II

Specific requirements. Volumetric Conversion Devices

A volumetric conversion device constitutes a subset of compliance with the second capability referred to in Article 2 definition v) of this Royal Decree.

The essential requirements applicable to gas meters are, where applicable, equally applicable to volumetric conversion devices. In addition, the following requirements apply:

7. Basic conditions for converted quantities: The manufacturer shall specify the basic conditions for the quantities converted.

8. Maximum allowed errors:

0,5% at an ambient temperature of 20 ° C +/-3 ° C, an ambient humidity of 60% +/-15%, and with the nominal values for the energy supply;

0.7% for temperature conversion devices under nominal operating conditions;

1% for other conversion devices under nominal operating conditions.

Note: The gas counter error is not considered.

9. Fitness:

9.1 An electronic conversion device must be able to detect when it operates outside the operating range pointed out by the manufacturer for each of the parameters involved in the accuracy of the measurement. If this happens, the conversion device must interrupt the integration of the converted quantity and be able to separate the amount converted for the time that is outside the range or operating intervals separately.

9.2 An electronic conversion device must be able to indicate all the data involved in the measurement without additional equipment.

PART III

On-service and compliance assessment

Put into service:

10.a) In the case of a measurement for residential use, if such measurement is performed by means of counters of the accuracy class 1.0, they must have a coefficient Q_max/Q_min equal to or greater than 150.

(b) As regards the requirements referred to in points 1.2 and 1.3 above, the competent public authorities shall ensure that the properties are determined by the distributor or by the person concerned. legally authorized to install the counter so that the counter is appropriate to accurately measure the intended or foreseeable consumption.

Conformity Assessment: The conformity assessment procedures referred to in Article 6, among which the manufacturer may choose are:

B + F or B + D or H1.

ANNEX VII

Specific essential requirements for active electrical energy meters

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 of this Royal Decree shall apply to the active electrical energy intended for residential, commercial or light industry use.

Although active electrical energy meters can be used in combination with external measurement transformers, depending on the measurement technique used, this annex refers only to energy meters. active electrical and not to the measurement transformers.

Definitions

An active electrical energy meter is a device that measures the active electrical energy that is consumed in a circuit.

I = electrical current intensity that circulates through the counter.

I_n = the specified reference stream intensity for which the transformer-connected counter was conceived.

I_st = the declared minimum value of I for which the counter registers the active electrical energy with power factor one (polyphase counters with balanced load).

I_min = I value above which the margin of error is within the maximum allowed errors (polyphase counters with balanced load).

I_tr = I value above which the margin of error is placed within the smallest allowed maximum error for the counter class index.

I_max = the maximum value of I for which the margin of error is within the maximum allowed errors.

U = the electrical voltage supplied to the counter.

U_n = the specified reference voltage.

f = the frequency of the voltage supplied to the counter.

f_n = the specified reference frequency.

FP = power factor = cosine = the cosine of the phase difference φ between I and U.

Internal placement counter: the one that can only be used in places that have additional protection against environmental influences (e.g. inside a building or outside in a housing that is enabled for effect).

External placement counter: One that can only be used in the open without additional protection against environmental influences.

Specific requirements

1. Accuracy: The manufacturer shall specify the class index of the counter. Class indexes are defined as: Class A, Class B, and Class C.

2. Nominal operating conditions: The manufacturer shall specify the nominal operating conditions of the counter; in particular:

The values of f_n, U_n, I_n, I_st, I_min, I_tr , and I_max that apply to the counter. For the current ad-intensive values specified the counter shall comply with the conditions set out in Table 1.

Table 1

For directly attached

		Class A	Class B	Class C
st	≤ 0.05-ltr	≤ 0.04-ltr	≤ 0.04-ltr
min	≤ 0.5-Itr	≤ 0.5-Itr	≤ 0.3-Itr
max	≥ 50-ltr	≥ 50-ltr	≥ 50- ltr
transformer-attached
st	≤ 0.06-ltr	≤ 0.04-ltr	≤ 0.02-ltr
	≤ 0.4-I	≤ 0.2-Itr *	≤ 0.2-Itr
n	= 20 -ltr	= 20-ltr	= 20-ltr
max	≥ 1.2-In	≥ 1.2- In	≥ 1.2-In

* For the electromechanical counters of class B, I_min ≤ 0.4-I_trwill be applied.

The voltage, frequency and power factor intervals within which the counter meets the maximum permissible error requirements are specified in Table 2 of this Annex. These intervals shall recognise the typical characteristics of electricity supplied by public distribution networks, for example voltage and frequency.

The voltage and frequency intervals shall be at least the following:

0.9 U_n ≤ U ≤ 1.1-U_n

0.98 f_n ≤ f ≤ 1.02-f_n

The FP interval will be at least from coss0 = 0.5 inductive to coss0 = 0.8 capacitive.

3. Maximum permissible errors: The effects of the different measurements and of the different influence measures (a, b, c, ...) are assessed separately, maintaining relatively constant in their reference values all other measured quantities Measurement and influence measures. The measurement error, which shall not exceed the maximum permissible error indicated in Table 2, shall be calculated as follows:

When the counter is operating under a variable load current, the error rate will not exceed the limits of Table 2.

Table 2

Maximum errors allowed in percent, in nominal operating conditions, and at a defined operating temperature and current load levels.

3.5

3.5

work with single-phase load

		Operating Temperature Margin Inner and outer placement			Operating temperature margin Interior Site			Operating Temperature Margin Outer
		+ 5 ° C ... + 30 ° C			-10 ° C ... + 40 ° C			-25 ° C ... + 55 °
Class	A	B	C	A	C		A	B	C
Monofasic counters; or polyphasics if they work with balanced load
min ≤ I < Itr	3.5	2	1	5	2.5	1.3	7	3.5	1.7
	Itr ≤ I ≤ Imax	3.5	2	0.7	4.5	2.5	1	3.5		1.3
1.3
Itr ≤ I ≤ Imax, see exception	4	2.5	1	5	3	1.3	7	4	1.7

For electromechanical polyphase counters, the current interval for single-phase load is limited to 5I_tr ≤ I ≤ I_max.

When a counter works at different temperature intervals, the corresponding values of the maximum allowable errors will be applied.

4. The permitted effect of disturbances.

4.1 Generalities: How electrical energy meters are directly connected to the power grid, and how the network current is also one of the measured magnitudes, for energy meters A special electromagnetic environment is used.

The counter must conform to the E2 electromagnetic environment and the additional requirements of the following points 4.2 and 4.3.

The electromagnetic environment and the permissible effects reflect a situation in which there are long-term disturbances that will not affect accuracy beyond the critical values of change and transient disturbances, and which may result in a temporary degradation or loss of performance or effectiveness, but of which the counter shall be recovered and which shall not affect the accuracy beyond the critical values of variation.

Where there is a foreseeable high risk due to lightning strikes or in situations where the air supply networks predominate, the metrological characteristics of the counter must be protected.

4.2 Effect of long-duration disturbances.

Table 3

Critical change settings for long-running perturbations

disturbance

Critical variation values, in percent, for the class
Reverse Order	A	B	C
	1.5	1.5
voltage imbalance (applicable only to polyphase counters)	4	2	1
Harmonic Content in Current Circuits. *	1	0.8	0.5
C. C. and harmonics in the current circuit. *	6	3	1.5
Rafagas	6	4	2
magnetic field; electromagnetic field HF (radiating RF); disturbances conducted by radio frequency fields; and immunity to oscillatory waves	3	2	1

* In the case of electromechanical electrical energy meters, no critical variation values are defined for the harmonic contents in the current and C.C. circuits and harmonics in the current circuit.

4.3 permissible effect of transient electromagnetic phenomena.

4.3.1 The effect of an electromagnetic disturbance on an electrical energy meter shall be such, during a disturbance and immediately after it, that:

Any output intended to check the accuracy of the counter does not result in pulses or signals corresponding to an energy exceeding the critical value of change, and in a reasonable time after the disturbance, the counter

will recover the operating capacity within the maximum allowable error margins, and

will keep all measurement functions in perfect condition, and

will allow recovery of all measurement data present before the application of the disturbance, and

will not indicate a variation of the recorded energy greater than the critical value of change.

The change critical value in kWh is m U_n • I_max • 10^-6

(m the number of meter metering elements, U_n in volts, and I_max in amps.)

4.3.2 For overintensity, the change critical value is 1.5%.

5. Fitness:

5.1 Below the nominal operating voltage, the counter error shall not exceed 10%.

5.2 The total energy visual indicator will have a sufficient number of figures for the counter to work for 4,000 hours at full load (I = I_max, U = U_n and PF = 1) the indication does not return to its initial value, and cannot be set to zero during use.

5.3 If the electrical energy is missing from the circuit, the total amounts of electrical energy must remain available for reading for at least 4 months.

5.4 Unladen operation: When the voltage is applied without running current in the current circuit (the current circuit shall be an open circuit), the counter shall not record energy at any voltage between 0,8 U_n and 1.1 U_n.

5.5 Boot: The counter will boot and continue to register U_n, PF = 1 (polyphasic counter with balanced loads) to a stream that is equal to I_st.

6. Units: The measured electrical energy shall be recorded in kilowatt hours, symbol kWh, or in megawatt/hour, symbol MWh.

7. Commissioning:

(a) In the case of commercial and/or light industrial use, the measurement shall not be carried out by means of class A counters.

(b) The competent Public Administration shall ensure that the range of electric current intensity is determined by the distributor or by the person designated legally to install the counter, so that this is appropriate to accurately measure consumption that is expected or foreseeable.

(c) For the purpose of putting into service and in accordance with Article 8 (2), the following temperature margin is set:

Indoor placement counters:-10 ° C to + 40 ° C

Exterior placement counters:-25 ° C to + 55 ° C

Conformity Assessment: The conformity assessment procedures referred to in Article 6, among which the manufacturer may choose are:

B + F or B + D or H1.

ANNEX VIII

Essential requirements specific to thermal energy counters

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 of this Royal Decree, shall apply to the thermal energy for residential, commercial or light industry use, defined below.

Definitions

A thermal energy meter is an instrument designed to measure heat that, in a heat exchange circuit, yields a liquid called heat-transmitting liquid.

A thermal energy meter is either a complete instrument or a combined instrument consisting of subassemblies: flow sensor, temperature sensor torque, and calculator, as defined in Article 2 (v), or a combination of these.

θ = the temperature of the heat transmitter liquid;

θ_in = the value of θ to the calorific exchange circuit entry;

θ_out = the value of θ at the output of the heat exchange circuit;

Δθ = the temperature difference θ_in -θ_orut, being Δθ ≥ 0;

θ_max = the maximum limit of θ for the thermal energy counter to function correctly within the maximum allowable errors;

θ_min = the minimum limit of θ for the thermal energy counter to function correctly within the maximum allowable errors;

Δθ_max = the maximum limit of Δθ for the thermal energy counter to function correctly within the maximum allowable errors;

Δθ_min = the minimum limit of Δθ for the thermal energy counter to function correctly within the maximum allowable errors;

q = the flow of the heat-transmitting liquid;

q_s = the highest value of q allowed for short periods of time for the counter to function correctly;

q_p= the highest value of q that is permanently allowed for the thermal energy counter to function correctly;

q_i = the lowest q value that is allowed for the thermal power counter to work correctly;

P = the thermal power of the heat exchange;

P_s = the maximum allowed limit of P for the thermal power counter to function correctly.

Specific requirements

1. Nominal operating conditions: The manufacturer shall specify the values of the nominal operating conditions as follows:

1.1 Liquid temperature: θ_max, θ_min,

temperature differences: Δθ_max, Δθ_min,

with the following limitations: Δθ_max /Δθ_min ≥ 10; Δθ_min = 3 K or 5 K or 10 K.

1.2 Liquid Pressure: The maximum positive internal pressure that the thermal energy meter can permanently support at the upper temperature limit.

1.3 Liquid Caudals: q_s, q_p, q_j, with the values of q_p and q_j, subject to the following limitation: q_p/q_j ≥ 10.

1.4 Thermal power: P_s.

2. Accuracy classes: The following accuracy classes are defined for the heat counters: class 1, class 2, class 3.

3. Maximum permissible errors applicable to complete thermal energy meters:

The maximum allowable errors applicable to a full thermal energy counter, expressed as a percentage of the actual value for each accuracy class, are:

For class 1: E = Ef + Et + Ec, being Ef, Et, Ec according to points 7.1 to 7.3.

For Class 2: E = Ef + Et + Ec, being Ef, Et, Ec according to points 7.1 to 7.3.

For Class 3: E = Ef + Et + Ec, being Ef, Et, Ec according to points 7.1 to 7.3.

4. Permitted influences of electromagnetic disturbances:

4.1 The instrument will not suffer the influence of static magnetic fields or electromagnetic fields at the frequency of the network.

4.2 The influence of an electromagnetic disturbance on an accountant shall be such that the change in the measurement result does not exceed the critical change value defined in paragraph 4.3, or the indication of the result of the measurement. measurement is such that it cannot be interpreted as a valid result.

4.3 The critical change value for a full thermal energy meter is equal to the absolute value of the maximum permissible error applicable to a thermal energy meter (see n. 3).

5. Durability: After an appropriate test has been carried out to take account of the time limit estimated by the manufacturer, the following criteria must be met:

5.1 Flow Sensors: The variation of the measurement result after the durability test when compared to the initial measurement will not be able to exceed the critical value of change.

5.2 Temperature sensors: The variation of the measurement result after the durability test when compared to the initial measurement shall not exceed 0,1 ° C.

6. Inscriptions to be included in a thermal energy meter:

The accuracy class.

Flow limits.

Temperature limits.

Temperature difference limits.

Place of flow sensor installation, flow direction, or return.

Indication of the direction of the flow.

7. Sub-assemblies: The provisions for subassemblies may be applied to subassemblies manufactured by the same manufacturer or by different manufacturers. Where the thermal energy counter consists of sub-assemblies, the essential requirements for such thermal energy counter shall be relevant to the sub-assemblies. The following shall also apply:

7.1 The maximum relative error allowed from the flow sensor, expressed as a percent, for the accuracy classes:

Class 1: Ef = (1 + 0.01 qp/q), but not more than 5%.

Class 2: Ef = (2 + 0.02 qp/q), but not more than 5%.

Class 3: Ef = (3 + 0.05 qp/q), but not more than 5%.

where the Ef error establishes a relationship between the indicated value and the actual value of the relationship between the token provided by the flow sensor and the mass or volume.

7.2 The maximum allowed relative error of the temperature sensor pair, expressed as a percent:

Et = (0.5 + 3Δθ_min/Δθ)

where the Et error binds the indicated value to the actual value of the relationship between the magnitude provided by the temperature sensor pair and the temperature difference.

7.3 The maximum allowable relative error of the calculator, expressed as a percentage:

Ec = (0.5 + Δθ_min/Δθ)

where the Ec error establishes a relationship between the indicated value of the heat and its actual value.

7.4 The critical change value of a subset of a thermal energy counter is equal to the corresponding absolute value of the maximum allowable error applicable to the subset (see 7.1, 7.2, or 7.3).

7.5 Inscriptions to be listed in the subsets:

Flow Sensor:

The accuracy class.

Flow limits.

Temperature limits.

The nominal count of the counter (p. ex. litres/boost) or output signal.

Indication of the direction of the flow.

Temperature sensor pair:

Identification of type (p. ex. Pt 100).

Temperature limits.

Temperature difference limits.

Calculator:

Type of temperature sensors.

Temperature limits.

Temperature difference limits.

Nominal factor required of the counter (p. ex. litres/pulse) or corresponding signal from the flow sensor.

Place of the flow-flow or return sensor installation.

Put into service:

8.a) In the case of a measurement for commercial or light industrial use, such measurement shall not be carried out by means of class 3 counter.

(b) As regards the requirements of points 1.1 to 1.4, the competent public administration shall ensure that the properties are determined by the dealer or the person legally appointed to install the counter, This means that it is appropriate to accurately measure consumption that is expected or foreseeable.

Compliance assessment:

9. The conformity assessment procedures referred to in Article 6, which may be chosen by the manufacturer, are:

B + F or B + D or H1.

ANNEX IX

System-specific essential requirements for continuous and dynamic measurement of quantities of liquids other than water

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 of this Royal Decree shall apply to the systems of a measure intended for the continuous and dynamic measurement of quantities (volumes or masses) of liquids other than water. If applicable, the terms 'volume' and 'L' in this Annex can be read as 'mass' and 'kg'.

Definitions

Counter: Instrument designed to continuously measure, memorize and indicate, under the measurement conditions, the amount of liquid that passes through the measurement transducer in a closed circuit and at full load.

Calculator: A part of a counter that receives the signals from the transducer or the measurement transducers and, where appropriate, from associated measuring instruments, and indicates the results of the measurement.

Associated measuring instrument: An instrument connected to the calculator to measure certain magnitudes that are characteristic of the liquid, in order to perform a correction or conversion.

Conversion Device: A part of the calculator that, taking into account the characteristics of the liquid (temperature, density, etc.), measured using associated measuring instruments, or stored in a memory, converts automatically:

the volume of liquid measured, under the conditions of measurement, by volume in the base or mass conditions, or

the mass of liquid measured, under the conditions of measurement, in volume under the conditions of measurement or volume in the base conditions.

Note: A conversion device includes the corresponding associated measurement instruments.

Base conditions: The specific conditions to which the amount of liquid is converted into the measurement conditions.

Measurement System: A system that includes the counter itself and all the devices necessary to ensure a correct measurement, or to facilitate measurement operations.

Fuel Dispenser/dispenser: A measurement system designed to supply fuel to motor vehicles, small boats and small aircraft.

Self-Service Mode: A mode that allows the customer to use a measurement system to obtain a liquid for their particular use.

Self-Service Device: A specific device that is part of a self-service mode and allows one or more measurement systems to operate within that self-service mode.

Minimum amount measured (CMM): The minimum amount of liquid for which the measurement is acceptable by the measurement system from the metrological point of view.

Direct Indication: The indication, by volume or mass, corresponding to the quantity subject to measurement that the counter is physically capable of measuring.

Note: The direct indication may be an indication to another quantity by means of a conversion device.

Interruptible/uninterruptible: A measurement system is considered interruptible/uninterruptible when the liquid flow can/cannot be easily and quickly stopped.

Liquid Flow Interval: The interval between the minimum flow rate (Q_min) and the maximum flow rate (Q_max).

Specific requirements

1. Nominal operating conditions: The manufacturer shall specify the nominal operating conditions of the instrument, in particular:

1.1 Liquid Flow Interval: The flow rate is subject to the following conditions:

i) The flow rate of a liquid in the measurement system shall be within the flow range of each of its elements, and in particular of the counter.

ii) Counter and measured system.

Table 1

measure system	Liquid characteristics	Min relation. between Qmax :Qmin
Surners	Non-liquefied Gases.	10: 1
	liquefied Gases.	5: 1
Measurement system	cryogenic liquids.	5: 1
Measurement systems on pipelines and measurement systems for loading ships	All types of liquids.	Suitable for this use
All other measurement systems	All types of liquids.	4: 1

1.2 Properties of the liquid to be measured by the instrument, specifying the name or type of liquid or its relevant characteristics, for example:

Temperature interval.

Pressure interval.

Density interval.

Viscosity interval.

1.3 Nominal value of alternating power voltage, limits of continuous power supply voltage, or both.

1.4 Base conditions for converted values.

Note: Point 1.4 is without prejudice to the obligations of the Member States to require either the use of a temperature of 15 ° C in accordance with Article 3 (1) of Council Directive 92/81/EEC of 19 October 1992 on the harmonisation of the structures of excise duty on mineral oils or on heavy fuels, LPG and methane, another temperature in accordance with Article 3 (2) of that Directive.

2. Classification of the maximum accuracy and maximum permissible errors:

2.1 For quantities equal to or greater than two litres the maximum error allowed in the indications is:

Table 2

Accuracy
0.3	0.5	1.0	1.5	2.5
Measurement Systems (A)	0.3%	0.5%	1.0%	1.5%	2.5%
%		0.3%	0.6%	1,0%	1.5%

2.2 For quantities less than two litres the maximum permissible errors, for the indications are:

Table 3

Measured Volume V

Maximum Allowed
V < 0.1 L	4 x value in Table 2, applied to 0.1 L.
L < V < 0.2 L	4 x value in Table 2.
0.2 L < V < 0.4 L	2 x value in Table 2, applied to 0.4 L.
0.4L < V < 1 L	2 x value in Table 2.
1 L < V < 2 L	Value in Table 2, applied to 2 L.

2.3 However, whatever the measured quantity, the magnitude of the maximum allowable error corresponds to the greater of the two values given below:

the absolute value of the maximum permissible error shown in Table 2 or Table 3;

the absolute value of the maximum allowed error for the minimum measure amount (Emin).

2.4.1 For minimum amounts measured above or equal to two litres, the following two conditions apply:

Condition 1:

E_min, will fulfill the condition: E_min > 2R, where R is the smallest interval of the scale ael device scale.

Condition 2:

The value E_min is obtained using the formula:

E_min = (2 CMM) x (N100), in which:

CMM is the minimum quantity measured and

A is the numeric value specified in line A in Table 2.

2.4.2 For minimum amounts measured less than two litres, the condition 1 above applies and E_min is twice the value expressed in Table 3, and relative to line A in Table 2.

2.5 Converted indication: If this is a converted indication, the maximum permissible errors are those listed in line A of Table 2.

2.6 Conversion devices: The maximum errors allowed in the converted indications, due to the conversion device, are the same ± (A-B), with A and B being the values specified in Table 2.

Parts of conversion devices that can be checked separately:

a) Calculator: The maximum error allowed for indications of amounts of liquids applicable to the calculation, positive or negative, is equal to one-tenth of the maximum permissible error defined in line A of Table 2.

(b) Associated measuring instruments: The associated measuring instruments shall have an accuracy, at least as good as the values in Table 4:

Table 4

EMP over measurements

Measurement system accuracy
0.3	0.5	1.0	1.5	2.5
Temperature	+ 0.3 ° C	+ 0.5 ° C			+ 1.0 ° C
	Less than 1 MPa: ± 50 kPa 1 to 4 MPa: ± 5% Greater than 4 MPa: ± 200 kPa
	Density	+ 1 kg/m3		+ 2 kg/m3		+ 5 kg/m3

These values apply to the indication of the amounts of liquid characteristics indicated by the conversion device.

c) Expose of the calculation function: The maximum error allowed for the calculation of each characteristic amount of the liquid, positive or negative, is equal to the two fifths of the value set out in the previous letter (b).

2.7 Requirement a) of point 2.6 applies to any calculation and not only to conversion.

3. Maximum permitted effects of disturbances:

3.1 The effect of an electromagnetic disturbance on a measurement system shall be one of the following:

a variation of the measurement result that does not exceed the critical change value as defined in point 3.2, or

that the measurement result indication shows a momentary variation that cannot be interpreted, memorized, or transmitted as a measurement result. In addition in case of interruptible systems, this may also be the impossibility of measuring any, or

that the variation of the measurement result is greater than the critical change value, in which case the measurement system shall allow the recovery of the measurement result just before the critical value of the measurement is produced. change and flow interruption.

3.2 The change critical value is the largest of emp/5 for a particular metric amount or E_min

4. Durability: After an appropriate test has been carried out to take account of the time limit estimated by the manufacturer, the following criterion must be met:

The variation of the measurement result after the durability test when compared to the result of the initial measurement shall not exceed the value for the counters specified in line B of Table 2.

5. Fitness:

5.1 For any measured amount corresponding to the same measurement, the indications provided by the various devices shall not deviate from each other in more than one step when the steps of the devices are the same value. If the steps are different, the deviation shall not exceed the highest step.

However, in the case of a self-service mode, the steps of the main indicator device of the measurement system and the steps of the self-service device shall be the same and shall not occur any deviation in the recorded measurement results.

5.2 It shall not be possible to divert the measured quantity under normal conditions of use, unless this is clearly manifest.

5.3 Any percentage of air or gas in the liquid, which is not readily detectable, shall not result in a variation in the error exceeding:

0,5% for liquids other than potables and for liquids the viscosity of which does not exceed 1 mPa-s, or

1% for potable liquids and for liquids the viscosity of which exceeds 1 mPa-s.

However, the allowed variation will never be less than 1% of CMM. This value applies in case of airbags or gas.

5.4 Instruments for Direct Selling:

5.4.1 The measurement systems for direct sales must be provided with a means to allow the indicator to be returned to zero.

It should not be possible to divert the measured amount.

5.4.2 The indication of the amount on which the transaction is based must be permanent until all parties involved in the transaction have accepted the result of the measurement.

5.4.3 Measure systems for direct sales will be interruptible.

5.4.4 If there is a percentage of air or gas in the liquid, it shall not result in a variation of the error greater than the values specified in paragraph 5.3.

5.5 Fuel dispensers/dispensers:

5.5.1 During measurement, it will not be possible to reset the fuel pump/dispenser indicators to zero.

5.5.2 The start of a new measurement will be locked until the indicator is back to zero.

5.5.3 When measuring systems are provided with an amount indicator, the difference between the amount indicated and the amount calculated from the unit price and the amount indicated shall not exceed the amount corresponding to the E_min. However, this difference is not required to be less than the minimum denomination of the monetary unit.

6. Electrical power interruption: The measurement systems shall either be equipped with a device for the supply of emergency electricity which shall safeguard all the measurement functions during the interruption of the power supply. main energy, or be equipped with a means to safeguard and display the data present to enable the completion of the current transaction and with a means of interrupting the flow of the liquid at the time the transaction is interrupted supply of the main source of energy.

7. Commissioning:

Table 5

accuracy class	Measurement system
0.3	Pipeline measurement systems.
0.5	All systems not specifically listed in this box, in particular:
low viscosity (< 20 mPa-s).
	measurement systems for (des) cargo ships, wagons, and tankers *
	measurement systems for the milk
	aircraft replenishment measurement systems
1.0	Measurement systems for liquefied gases under pressure measured at a temperature equal to or greater than -10 ° C
	Measurement system that typically corresponds to class 0.3 or 0.5 but used for liquids:
	whose temperature is less than -10 ° C or greater than 50 ° C.
	whose dynamic viscosity is greater than 1000 mPa-s.
	whose maximum volumetric flow rate is not greater than 20 I/h.
1.5	Systems Measured for liquefied carbon dioxide
	Measurement systems for liquefied pressure gases measured at temperatures below -10 ° C (except cryogenic liquids).
2.5	Measurement systems for cryogenic liquids (temperature below -153 ° C).

Note: However, the manufacturer may specify a better class of accuracy for certain types of measurement systems.

8. Units of measurement: The measured quantity shall be presented in millilitres, cubic centimetres, litres, cubic metres, grams, kilograms or tonnes.

Conformity Assessment: The conformity assessment procedures referred to in Article 6, among which the manufacturer may choose are:

B + F or B + D or H1 or G.

ANNEX X

Specific requirements specific to automatic weighing instruments

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 of this Royal Decree shall apply to the instruments of automatic weighing which are defined below the purpose of which is to determine the mass of a body by using the action of gravity on that body.

Definitions

Automatic Weighing Instrument: An instrument that determines the mass of a product without the intervention of an operator and follows a predetermined program of automatic process characteristic of the instrument.

Automatic-weight selection: An automatic weighing instrument that determines the mass of previously collected discrete loads (for example, prepackaged) or individual loads of loose material.

Automatic Control-Weighted Select: Automatic-weight selection that subdivides items from different mass into two or more groups based on the value of the difference in their mass and a nominal reference point.

Weight Label: Auto-weight selection that places labels on individual items with the weight value.

Weight Label/Price Tag: Automatic weight selection that places labels on individual items with the value of the weight and price information.

Automatic-run-fill gravimetric instrument: Automatic-run weighing instrument that fills containers with a predetermined and virtually constant bulk of bulk product.

Discontinuous totalizer (hopper-totalizer): An automatic weighing instrument that determines the bulk of the bulk product by dividing it into discrete loads. The mass of each discrete load is sequentially determined and added. Then, each discrete load is put back in bulk.

Continuous Totalizer: An automatic weighing instrument that continuously determines the mass of a bulk product on a conveyor belt without having to systematically subdivide the product and without interrupt the movement of the conveyor belt.

Railroad Bridge Scale: Automatic Operation Weighing Instrument equipped with a load receiver and which includes rails for carriage of wagons.

Specific requirements

Chapter I. Requirements common to all types of automatic weighing instruments:

1. Nominal operating conditions: The manufacturer shall specify the nominal operating conditions of the instrument as follows:

1.1 For Measurement: The measurement field in terms of maximum and minimum scope.

1.2 For Power Power Influence Measures:

In the case of AC power voltage: the nominal power voltage in alternating current, or the power limits in alternating current.

In the case of continuous power supply voltage: the nominal and minimum voltage in continuous current, or the power limits in continuous current.

1.3 For mechanical and climatic influence measures: The minimum temperature range is 30 ° C, unless otherwise specified in the following chapters of this Annex.

The mechanical environment classes are not applied in accordance with paragraph 1.3.2 of Annex IV. For instruments that are used with special mechanical stress, for example those incorporated in vehicles, the manufacturer shall specify the mechanical conditions of use.

1.4 For other influence measures (if applicable):

The operating condition (s).

The characteristics of the product (or products) to be weighed.

2. The permitted effect of disturbances. Electromagnetic environment: The required performance and the critical change value are shown in the corresponding chapter of this annex to each type of instrument.

3. Fitness:

3.1 The appropriate means shall be available to limit the effects of the inclination, load and flow rate so that the maximum permissible errors are not exceeded under normal operating conditions.

3.2 Appropriate material handling devices must be available so that the instrument can respect the maximum errors allowed during normal operation.

3.3 Any control interface by the operator must be clear and effective.

3.4 The integrity of the indication (if any) must be checked by the operator.

3.5 An appropriate grounding device must exist so that the instrument can be adjusted to the maximum error margins allowed during normal operation.

3.6 Any result that exceeds the measurement field must be identified as such, when printing is possible.

4. Conformity assessment: The conformity assessment procedures referred to in Article 6, which may be chosen by the manufacturer, are as follows:

For mechanical systems:

B + D or B + E or B + F or D1 or F1 or G or H1.

For electromechanical instruments:

B + D or B + E or B + F or G or H1.

For electronic systems or systems that contain computer programs:

B + D or B + F or G or H1.

Chapter II. Auto-weighted selector:

1. Accuracy classes:

1.1 The instruments are divided into two primary categories:

X or Y

as specified by the manufacturer.

1.2 These primary categories are further divided into four classes of accuracy:

XI, XII, XIII & XIIII

and

Y (I), Y (II), AND (a) &Y (b)

that the manufacturer must specify.

2. Instrument category X:

2.1 Category X applies to the instruments used to check pre-packages made in accordance with the requirements laid down by Royal Decree 723/1988 of 24 June 1988 on the control of effective content of packaged food products.

2.2 The accuracy classes are supplemented by a factor (x) that quantifies the maximum permitted standard deviation as specified in point 4.2.

The manufacturer must specify the factor (x), where (x) must be ≤ 2, and respond to the form 1x10^k, 2x10^k , or 5x10^k, with k being an integer or zero.

3. Category Y of instruments: The Y category applies to all other automatic weight-select machines.

4. Maximum allowed error:

4.1 Average error of the instruments in category X. Maximum allowed error of category Y instruments.

Table 1

load (m) on verification steps (e)				Maximum average error allowed				Maximum Allowed
XI	Y (l)	XII	Y (ll)	XIII	Y (a)	Xllll	Y (b)	X
0 < m < 50 000		0 < m < 5000		0 < m < 500		0 < m < 50		+0.5 e	+ 1 and
50 000 < m < 200 000		5 000 < m < 20 000		500 < m < 2 000		50 < m < 200		+1.0 e	+1.5 e
200 000 < m		20 000 < m < 100 000		2 000 < m < 10 000		200 < m < 1 000		+ 1.5 e	+ 2

4.2 Typical deviation: The maximum allowable value for the standard deviation of the instruments of class X (x) is the result of multiplying the factor (x) by the value indicated in Table 2.

Table 2

load (m)	Maximum typical deviation allowed for class X (1)
m ≤ 50 g	0.48%
50 g < m ≤100 g	0.24 g
100 g < m ≤ 200 g	0.24%
200 g < m ≤ 300 g	0.48 g
g < m ≤ 500 g	0.16%
500 g < m ≤1000 g	0.8 g
1 000 g < m ≤ 10 000 g	0.08%
000 g < m ≤ 15 000 g	8 g
15 000 g < m	0.053%

For classes XI and XII, (x) will be less than 1.

For class XIII, (x) will not be greater than 1.

For class Xllll, (x) will be greater than 1.

4.3 Verification Escalation. Single-step instruments:

Table 3

accuracy classes		Verification Escalation	Number of verification steps n = Max/
			Minimum
XI	Y (I)	0.001 g < e	50 000	-
XII	Y (II)	0.001 g < e < 0.05 g	100	100 000
		0.1 g < e	5 000	100
XIII	Y (a)	100	100	10 000
				100				5 g < e	500	10 000
	Xllll	Y (b)	5 g < e	100	1 000

4.4 Verification Escalation. Multi-step instruments:

Table 4

accuracy classes		Verification Escalation	Number of verification steps n = Max/
			value (1) N = Maxi/e(i + 1)	Maximum value n = Maxi/ei
XI	Y (I)	0.001 g < ei	50 000	-
XII	Y (II)	0,001 g < e, ≤ 0,05 g	5 000	100 000
		0.1 g < andi	5 000	100 000
XIII	Y (a)	0.1 g < ei	500	10 000
Xllll	Y (b)	5 g < ei	50	1 000

(1) For i = r, the corresponding columns in Table 3 are applied by replacing and by and_r.

Being:

i = 1, 2, ...... r.

i = partial weighing field.

r = total number of partial fields.

5. Measure field: When specifying the measurement field for the instruments of the class Y, the manufacturer must take into account that the minimum scope must not be less than:

claseY (1): 100 e

class Y (II):

20 e for 0,001 g ≤ e ≤ 0,05 g and

50 e for 0.1 g ≤ e

claseY (a): 20 e

claseY (b): 10 e

Balances used for sorting, for example, mailings and waste weighers: 5 e

6. Dynamic tuning:

6.1 The dynamic tuning device must operate in the load interval specified by the manufacturer.

6.2 When installed, the dynamic adjustment device that compense the dynamic effects of the moving load shall be inhibited in case of operation outside the load interval and must be able to be protected.

7. Operation under influence factors and with electromagnetic disturbances:

7.1 Maximum allowable errors due to influence factors are:

7.1.1 For category X instruments:

For automatic operation, those specified in Tables 1 and 2.

For non-automatic static weighing, the ones specified in Table 1.

7.1.2 For Category Y instruments:

For each auto-operating load, those specified in Table 1.

For non-automatic static weighing, those specified for category X in Table 1.

7.2 The critical value of the change due to a disturbance is a verification step.

7.3 Temperature Interval:

For classes XI and Y (I), the minimum interval is 5 ° C.

For classes XII and Y (II), the minimum interval is 15 ° C.

Chapter III. Automatic-run-filling gravimetric instruments:

1. Accuracy classes:

1.1 The manufacturer must specify both the reference accuracy class Ref (x) and the operating accuracy class (s), X (x).

1.2 An instrument model is assigned a reference accuracy class, Ref (x), according to the best possible accuracy for the instruments of that model. Once the individual instruments are installed, they are assigned one or more operating accuracy classes, X (x), taking into consideration the specific products to be measured. The class designation factor (x) must be ≤ 2 and respond to the form 1 x 10k, 2 x 10k or 5 x 10k, with k being an integer or zero.

1.3 Reference accuracy class, Ref (x), applies to static weighing.

1.4 In the operating accuracy class X (x), X is a ratio of accuracy to load weight and (x) is a multiplier for the error limits set for class X (1) in point 2.2.

2. Maximum allowed error:

2.1 Static weighing error.

2.1.1 For static loads and in nominal operating conditions, the maximum error allowed for the reference accuracy class Ref (x) shall be 0,312 of the maximum permitted deviation of each filling load with for the mean, as specified in Table 5, multiplied by the class designation factor (x).

2.1.2 For instruments where the filling load can be carried out by one or more loads (p. For example, cumulative or selective combinators), the maximum permissible error for static weighing shall be the accuracy required for the filling load as specified in point 2.2 (i.e. not the sum of dmp (maximum deviation) allowed) for individual weigh-ins.)

2.2

Table 5

mass value fill m (g)	Maximum deviation allowed for each filling load with respect to the average corresponding to class X (1)
m ≤ 50	7.2%
50 < m ≤ 100	3.6 g
100 < m ≤ 200	3.6%
200 < m ≤ 300	7.2 g
< m ≤ 500	2.4%
< m ≤ 1 000	12 g
1 000 < m ≤ 10 000	1.2%
000 < m ≤ 15 000	120 g
15000 < m	0.8%

Note: The calculated deviation of each fill load with respect to the mean can be adjusted to counteract the effect of the particle size of the material.

Deviation from the average fill load value.

2.3 Default value error (adjustment error): For instruments in which a weight of the fill load can be predetermined, the maximum difference between this and the average mass value of the filling loads it shall not exceed 0,312 of the maximum permitted deviation of each filling load with respect to the average, as set out in Table 5.

3. Operation due to influence factors and in case of electromagnetic disturbance:

3.1 The maximum error allowed due to influence factors is the one specified in point 2.1.

3.2 The critical change value due to a disturbance is a variation of the static weighing indication equal to the maximum permissible error as set out in paragraph 2.1 calculated for the minimum nominal fill load, or a variation that has an equivalent effect on the load of filling in the case of instruments in which the filling consists of multiple loads. The calculated change critical value shall be rounded to the nearest higher step (d) value.

3.3 The manufacturer shall specify the value of the minimum nominal fill load.

Chapter IV. Discontinuous totalizer:

1. Accuracy classes: The instruments are divided into four classes of accuracy, namely: 0.2; 0.5; 1; 2.

2. Maximum allowed error:

Table 6

accuracy class	Maximum allowable load
0.2	± 0.10%
	0.5	± 0.25%
1	± 0.50%
2	± 1.00%

3. Totalization step: The totalization step (d_t) must be between the following limits:

0.01% Max < d_t < 0.2% Max

4. Minimum total load (Σ_mIn): The minimum total load (Σ_min) must not be less than the load for which the maximum allowed error is equal to the totalization step (d_t) and must not be less than the minimum load specified by the manufacturer.

5. Set-to-zero device: Instruments that do not carry weight after each discharge must have a set-to-zero device. Automatic operation shall be interrupted when the indication of zero varies in:

1 d_t on instruments with automatic zeroing device.

0.5 d_t on instruments with semi-automatic, or non-automatic, set-zero device.

6. Interface with the operator: The operator settings and the zeroing function must be nullified during automatic operation.

7. Printing: In instruments that are equipped with a printing device, the reinitialization of the total must wait for the total to be printed. Printing of the total should occur when automatic operation is interrupted.

8. Operation due to influence factors and in case of electromagnetic disturbances:

8.1 The maximum error allowed due to influence factors is the one specified in Table 7.

Table 7

(m) in totalization steps (dt)	Maximum allowable
0 < m 5 500	± 0.5 dt
< m ≤ 2 000	± 1.0 dt
2 000 < m ≤ 10 000	± 1.5

8.2 The critical change value due to a disturbance is a totalization step for any weight indication and for any stored total.

Continuous Chapter V. Totalizer:

1. Accuracy classes: The instruments are divided into three classes of accuracy, namely:

0.5; 1; 2.

2. Measure field:

2.1 The manufacturer shall specify the field of measurement, the ratio of the minimum net load in the weighing unit, the maximum range and the minimum total load.

2.2 The total minimum load of the_min must not be less than:

800 d for class 0.5,

400 d for class 1,

200 d for class 2.

Where d is the totalization step of the overall totalization device.

3. Maximum allowed error:

Table 8

accuracy class	Maximum allowed error for the total
0.5	± 0.25%
1	± 0.5%
2	± 1.0%

4. Tape speed: The manufacturer shall specify the speed of the conveyor belt. For single speed conveyor belt scales and variable speed conveyor belt scales with a manual speed control device, the speed shall not vary by more than 5% of the nominal value. The product must not have a different speed of the speed of the conveyor belt.

5. General totalization device: It should not be possible to put the general totalization device back to zero.

6. Operation in case of factors of influence and of electronic disturbances:

6.1 The maximum error allowed due to influence factors, for a load not less than 0,7_min shall be equal to 0,7 times the appropriate value specified in Table 8, rounded to the nearest step of totalization (d).

6.2 The critical change value due to a disturbance must be equal to 0.7 times the appropriate value specified in Table 8, for a load equal to_min, for a given tape accuracy class conveyor, rounded to the nearest top-toting step (d).

Chapter VI. Rail bridge scale:

1. Accuracy classes:

The instruments are divided into four classes of accuracy, namely:

0.2; 0.5; 1; 2.

2. Maximum allowed error:

2.1 The maximum permissible errors for the moving weighing of a single wagon or of a whole train are as shown in Table 9.

Table 9

accuracy class	Maximum allowable
0.2	± 0.1%
0.5	± 0.25%
1	± 0.5%
2	± 1.0%

2.2 Maximum allowable errors for the movement of hooked or unhooked wagons shall be the highest value of the following:

the value calculated according to Table 9, rounded to the nearest step;

the value calculated according to Table 9, rounded to the nearest step for a weight equal to 35% of the maximum weight of the wagon (as indicated in the descriptive indications);

a step (d).

2.3 The maximum allowable errors for the weighing in train movement shall be the highest value of the following:

the value calculated according to Table 9, rounded to the nearest step;

the value calculated in accordance with Table 9, for the weight of a single wagon, equal to 35% of the maximum weight of the wagon (as indicated in the descriptive indications) multiplied by the number of reference wagons (which shall not be exceed 10) on the train, rounded to the nearest step;

one step (d) for each train wagon but not to exceed 10 d.

2.4 Where the weighing of engaged wagons is carried out, errors not exceeding 10% of the results of the weighing of one or more of the train passes may exceed the maximum permissible error corresponding to paragraph 2.2, but not they must exceed twice that value.

3. Step (d): The relationship between the accuracy class and the step shall be that specified in Table 10.

Table 10

accuracy class	Escalon (d)
0.2	d ≤ 50 kg
0.5	d ≤ 100 kg
1	d ≤ 200 kg
2	d ≤ 500 kg

4. Measure field:

4.1 The minimum range shall not be less than 1 t or greater than the value of the minimum weight of the wagon divided by the number of partial weights.

4.2 The minimum weight of the wagon shall not be less than 50 d.

5. Operation in case of an influence factor and electromagnetic disturbance:

5.1 The maximum error allowed due to an influence factor will be the one specified in Table 11.

Table 11

(m) on verification steps (d)	Maximum allowable
0 < m ≤ 500	± 0.5 d
< m ≤ 2 000	± 1.0 d
2 000 < m ≤ 10 000	± 1.5 d

5.2 The critical change value due to a disturbance is a verification step.

ANNEX XI

Specific requirements specific to taximeters

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 shall apply to taximeters.

Definitions

Taximeter: A device that works together with a signal generator * to constitute a measuring instrument. The device measures the elapsed time and calculates the distance based on a signal sent by the distance signal generator. It also calculates and visibly indicates the amount to be paid for a journey based on the calculated distance, the measured duration of the journey or both.

Service Amount: The total amount of money that is due for a journey, based on an initial fixed rate and/or the distance and/or the length of the journey. The amount of the service does not include any additional services supplement.

Drag Change Rate: The rate that results from dividing the value for the time rate by the value for the distance-based rate.

Normal calculation mode S (application of a single tariff): Calculation of the amount of the service based on the application of the temporary tariff when the speed is lower than the speed of the change of drag and in the application of the rate based on the distance when the speed is higher than the speed of the shift.

Normal calculation mode D (application of a double rate): Calculation of the amount of the service based on the simultaneous application of the temporary tariff and the rate based on the distance during the entire service.

Operating Position

The different ways in which the taximeter runs the different parts of its operation. The operating positions are differentiated by the following indications:

"Free": The operating position in which the calculation of the service amount is off.

"Busy": The operating position in which the calculation of the service amount takes place on the basis of a possible initial amount and a per-time or service-time distance rate of the service or both.

"To Pay": The operating position in which the amount to be paid for the service is indicated and at least the function of calculating the amount of the time-based service is off.

* The distance signal generator is not included in the scope of this Royal Decree.

Specific requirements

1. Any taximeter shall be designed to measure the distance and duration of a service.

2. The taximeter shall be designed to calculate and visibly indicate the amount of the service with its increment by intervals equivalent to a resolution of 0,05 € in the 'Occupied' operating position. The taximeter must also visibly indicate the final value due to the service in the "A pay" operation.

3. Any taximeter must be able to apply the normal modes of calculation S and D. It shall be possible to choose between the modes of calculation by means of a secure device.

4. Any taximeter must be able to provide the following data through one or more appropriate and protected interfaces:

operating position: "Free", "Busy" or "To pay",

data totalizer according to point 15.1.,

general information: distance signal generator constant, seal date, taxi identifier, actual time, rate identification,

information about the amount of service per trip: total amount invoiced, amount of service, calculation of service amount, supplements for additional services, date, start time, end time, distance travelled on the journey,

rate or rate information: rate or rate parameters.

Certain additional devices may be connected to a taximeter through one or more secure interfaces, in such a case, the possibility of automatically inhibiting the operation of the taximeter must exist, by means of a secure system, for reasons of absence or incorrect operation of those additional devices.

5. If relevant, it shall be possible to adjust a taximeter to the constant of the distance signal generator to which it is to be connected, and to protect such an adjustment.

Nominal operating conditions:

6.1 The applicable mechanical environment class is the M3.

6.2 The manufacturer shall specify the nominal operating conditions applicable to the instrument, in particular:

A minimum temperature range of 80 ° C for the climate environment

The limits of the continuous stream supply for which the instrument was conceived.

Maximum errors allowed.

7. Maximum allowable errors, excluding any errors due to the application of the taximeter in a taxi, are:

For elapsed time: ± 0.1%

minimum allowed maximum error value: 0.2 s

For distance traveled: ± 0.2%

minimum allowed maximum error value: 4 m

For calculation of amount: ± 0,1%

minimum, including rounding: the value corresponding to the last significant digit of the indication of the amount.

Allowed effects of disturbances

8. Electromagnetic immunity:

8.1 The applicable electromagnetic class is E3.

8.2 The maximum permitted errors set out in point 7 shall also be respected in the presence of an electromagnetic disturbance.

Power power supply outage:

9. In the event of a decrease in the supply of voltage to a value below the minimum operating limit specified by the manufacturer, the taximeter shall

continue to function correctly or resume proper operation without loss of data that was available prior to the current download if the current outage is temporary, for example because it has been returned to start up the engine

interrupt the existing measurement and return to the "Free" position if the current interrupt is for a longer period.

Other requirements:

10. The manufacturer of the taximeter shall specify the compatibility conditions between the taximeter and the distance signal generator.

11. If a supplement is charged because of an extraordinary service, which the driver has introduced manually, this supplement must be excluded from the amount displayed. However, in this case the taximeter may temporarily display the amount of the service including that supplement.

12. If the amount of the service is calculated according to method D, the taximeter may have an additional mode of visual indication in which only the total distance travelled and the duration of the journey are displayed in real time.

13. All values displayed to the passenger shall be identified in a convenient manner. These values and their identification shall be clearly legible in daytime and night lighting conditions.

14.1 If the fee to be paid or the measures to be taken against fraudulent use may be affected by the choice of functionality from a previously scheduled configuration or may determine freely, it shall be possible to protect the adjustment of the instrument and the data entered.

14.2 The protection possibilities of a taximeter must be such that protection can be possible separately from the adjustments.

14.3 The provisions of point 8.3 of Annex IV also apply to tariffs.

15.1 The taximeters will be provided with totalizers that cannot return to their initial value for all of the following values:

The total distance traveled by the taxi.

The total distance traveled by the "busy" taxi.

The total number of services.

The total amount charged as a supplement.

The total amount charged as the amount of the service.

The total values shall include the values safeguarded according to paragraph 9 under conditions of power supply interruption.

15.2 If the power is disconnected, the taximeter will allow the total values to be stored for one year in order to transmit the values of the taximeter to another medium.

15.3 Appropriate measures shall be taken to prevent the use of the aggregate value indicator to mislead passengers.

16. Automatic change of rates will be allowed for:

the distance from the service;

the duration of the service;

the time of day;

the date;

on the day of the week.

17. If the taxi characteristics are important for the correction of the taximeter, the taximeter will have means to ensure the connection of the taximeter to the taxi in which it is installed.

18. For testing after installation, the taximeter shall have the possibility to check the accuracy of the measurement of time and distance, independently, as well as the accuracy of the calculation.

19. A taximeter and its installation instructions specified by the manufacturer shall be such that, if it is installed in accordance with the manufacturer's instructions, the possibility of fraudulently altering the measurement signal is sufficiently excluded. which represents the distance travelled.

20. The general essential requirement relating to fraudulent use shall be met in such a way as to protect the interests of the customer, the driver, the driver's employer and the tax authorities.

21. The taximeter shall be designed to enable it to respect the maximum permissible errors without adjustment for a period of one year of normal use.

22. The taximeter shall be equipped with a real-time clock to maintain the time of day and date, and one of these, or both, may be used for automatic rate change. The following requirements apply to the actual time clock:

The time record will have an accuracy of 0.02%.

The possibility of clock correction will not be greater than 2 minutes per week. The summer and winter time correction will be automatically performed.

The correction, both automatic and manual, will be prevented during the journey.

23. The values of the distance travelled and the elapsed time, when displayed or printed according to this Royal Decree, shall be expressed in the following units:

Distance traveled:

kilometers.

Elapsed Time:

seconds, minutes, or hours as appropriate, taking into account the required resolution and the need to avoid misinterpretations.

Compliance assessment:

The conformity assessment procedures referred to in Article 6 among which the manufacturer may choose are:

B + F or B + D or H1.

ANNEX XII

Specific requirements specific to materialized measures

Chapter I. Length materialized measure.

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 shall apply to the materialised measures of length, defined below. However, it may be considered that the requirement for the submission of a copy of the declarations of conformity is applicable to a whole consignment, or to a consignment, and not to each individual instrument.

Definitions

Materialized measure of length: An instrument composed of a scale whose distance between traces is indicated in legal units of length.

Specific requirements

Reference conditions:

1.1 For metric tapes of five metres or more, the maximum permissible errors shall be given when applying a tensile strength of fifty newtons or other force values specified by the manufacturer and marked on the tape accordingly; in the case of rigid or semi-irrigated measures no traction force shall be required.

1.2 The reference temperature shall be 20 ° C, unless the manufacturer specifies otherwise and is marked to the extent in accordance with this.

Maximum errors allowed:

2. The maximum allowed, positive or negative error in mm, over the length between two non-consecutive strokes of the scale responds to the expression (a + bL), where:

L is the value of the over-rounded length to the next entire meter, and

a and b are listed in Table 1.

When a terminal graduation is limited by a surface, the maximum error allowed for any distance starting at that point is increased by the value c shown in Table 1.

Table 1

D -Special Class for Immersion Tapes. ^1
2 Less than or equal to 30 m.

accuracy class	a (mm)	b	c (mm)
I	0.1	0.1	0.1
II	0.3	0.2	0.2
III	0.6	0,4
1.5	zero	zero
S -special class for deposit meditating tapes. For every 30 m length, when the tape is on a flat surface.	1.5	zero	zero

¹ Applies to tape and ballast combinations.

² If the nominal length of the tape exceeds 30 m, the maximum allowable error (emp) may be increased by 0.75 mm for every 30 m of the tape length.

Immersion tapes may also belong to Classes I or II; in this case for any length between two scale marks, one of which is on the ballast and the other on the carrier tape, the emp is + 0.6 mm when the application of the formula of a value of less than 0,6 mm.

The maximum error allowed for the length between consecutive graduations of the scale and the maximum difference allowed between the length of two consecutive intervals are shown in Table 2.

Table 2

Length i length

Maximum error or difference allowed, in millimeters, according to the accuracy class
	I	II	III
i ≤ 1 mm	0.1	0.2	0.3
1 mm < i ≤ 1 cm	0.2	0.4	0.6

When a measure of length is of folding type the joints shall be made so that they do not cause additional errors to the above mentioned above, which exceed 0,3 mm for Class II, and in 0,5 mm for Class III.

Materials:

3.1 The materials used for the materialised measures must be of a type that allows variations in length due to temperature variations of up to ± 8 ° C at the reference temperature not exceeding of the maximum allowed error. This rule does not apply to measures of class D and class S when the manufacturer intends to apply to the observed readings, where appropriate, corrections by thermal expansion.

3.2 Measures manufactured with materials such that their dimensions may be materially altered when subjected to a wide range of relative humidity may only be included in Classes II and III.

Numbering:

4. The nominal value shall be indicated in the measure. The millimeter scales shall be numbered in each centimetre and the measurements with a step greater than 2 cm shall have their scale strokes numbered.

Conformity Assessment: The conformity assessment procedures referred to in Article 6 among which the manufacturer may choose are:

F1 or D1 or B + D or H or G.

Chapter II. Measures of capacity to serve liquid for immediate consumption

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 shall apply to those of capacity used for to serve immediate consumer liquids, as defined below. However, it may be considered that the requirement for the submission of a copy of the declarations of conformity is applicable to a whole consignment, or to a consignment, and not to separate instruments. In addition, the requirement that information on the accuracy class should be indicated in the instrument shall not apply.

Definitions

Measure of ability to serve liquid for immediate consumption: A measure of capacity (such as a glass, a jug or a thimble) designed to determine a specific volume of liquid (other than a pharmaceutical product) sold for immediate consumption.

Stroke Measure: A measure that serves to indicate the capacity that is provided with a stroke indicating the nominal capacity.

Stop measure: A measure that serves to indicate the capacity at which the internal volume is equal to the nominal capacity.

Trasiego Measure: A measure that serves to indicate capacity and from which a liquid is decanted before consumption.

Capacity: The capacity is the internal volume for the stop measures or the internal volume up to the trace in the stroke measures.

Specific requirements

1. Reference conditions:

1.1 Temperature: The reference temperature for measuring capacity is 20 ° C.

1.2 Position for correct indication: stable on a level surface.

2. Maximum allowable errors

Table 1

Trasiego Measures	Tracing	Tope
< 100 mL	± 2 mL	-0
		+ 4 mL
≥ 100 mL	± 3%	-0
		+ 6%
Measures to serve
	< 200 mL	± 5%	-0
		+ 10%
≥ 200 mL	± 5 mL + 2.5%	-0
		+ 10 mL + 5%

3. Materials: Measures to serve capacity units shall be made of sufficiently rigid and dimensionally stable materials to maintain capacity within the maximum permitted margin of error.

4. Form:

4.1 Trasiego measures shall be designed in such a way that a change of content equal to the maximum permissible error causes a change of at least 2 mm at the level of the stop or the fill mark.

4.2 Trasiego measures shall be designed so that they do not allow the full discharge of the measured liquid.

5. Marking:

5.1 The declared nominal capacity must be clearly and indelibly marked in the measure.

5.2 Measures to serve capacity units can also be marked with up to three clearly distinguishable capabilities, none of which will result in one being confused with one another.

5.3 All filling marks will be clear and durable enough to ensure that maximum allowable errors are not exceeded with usage.

Conformity Assessment: The conformity assessment procedures referred to in Article 6 among which the manufacturer may choose are:

A1 or F or D1 or E1 or B + E or B + D or H.

ANNEX XIII

Essential requirements specific to instruments for dimensional measures

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 shall apply to the instruments for measures dimensional of the types that are defined below.

Definitions

Length measurement instrument: A length measuring instrument is used to determine the length of cord-type materials (e.g., textiles, tapes, and cables) during the movement of the product. must be measured.

Area Measurement Instruments: An area measuring instrument serves for the determination of the area of irregularly shaped objects, for example leather.

Instruments for Multidimensional Measures: An instrument for multidimensional measurements serves to determine the length of the edges (length, height, width) of the smallest rectangular parallelepiped that frame a product.

Chapter I. Specific requirements common to all instruments for dimensional measures:

Electromagnetic immunity:

1. The effect of an electromagnetic disturbance on an instrument for multi-dimensional measurements shall be such that:

the change in the measurement result does not exceed the critical change value defined in point 2, or

it is impossible to perform any measurement, or

momentary variations of the measurement result that cannot be interpreted, memorized, or transmitted as a valid result, or

the variations in the measurement result are important enough for the stakeholders to be aware of the results of the measurement.

2. The critical value of change shall be equal to one step.

Conformity Assessment: The conformity assessment procedures referred to in Article 6 among which the manufacturer may choose are:

For mechanical or electromechanical instruments:

F1 or E1 or D1 or B + Fo B + E or B + D or H or H1 or G.

For electronic instruments or instruments that include software:

B + F or B + D or H1 or G.

Chapter II. Instruments for measuring lengths:

Product characteristics to measure:

1. Textile materials are characterized by the characteristic factor K. This factor takes into account the stretching capacity and the strength per unit surface of the measured product and is defined by the following formula:

K = ε (GA + 2.2 N/m²), where

ε: is the relative elongation of a 1 m wide tissue sample for a 10 N traction force,

GA: The weight per surface unit of a tissue sample at N/m².

Operating Conditions:

2.1 Value Interval: The dimensions and the K factor, if any, in the range of values specified by the manufacturer for the instrument. The value range of the K factor is the one shown in Table 1:

Table 1

K Value Interval	Product
I	0 < K < 2x10-2 N/m2	Low Stretch
	2x10-2 N/m2 < K < 8x10-2 N/m2	Medium Stretch.
III	8x10-2N/m2-2N/m2	Stretching raised.
IV	24x10-2 N/m2 < K	Very Stretching raised.

2.2 In cases where the measured object is not carried by the measuring instrument, its speed must be within the range of values specified by the manufacturer for the instrument.

2.3 If the measurement result depends on the thickness, surface finish, and distribution type (for example, from a large roll or from a stack), the corresponding limitations must be specified by the manufacturer.

Maximum errors allowed:

3. Instrument:

Table 2

class	Maximum allowable
I	0.125%, but not less than 0.005 Lm
II	0.25%, but not less than 0.01 Lm.
III	0.5%, but no less than 0.02 Lm

Being L_m the minimum measurable length, i.e. the minimum length specified by the manufacturer for which the instrument was conceived.

The true length value of different types of materials should be measured using appropriate instruments (for example, metric tapes). The material to be measured must therefore be deposited on an appropriate support (e.g. a suitable table), straight and unstretched.

Other requirements:

4. The instruments must ensure that the product is measured without stretching, according to the stretching capacity for which the instrument was designed.

Chapter III. Instruments for measuring areas:

Operating Conditions:

1.1 Value Interval: Dimensions within the range of values specified by the manufacturer for the instrument.

1.2 Product Condition: The manufacturer shall specify the limitations of the instruments due to the speed, thickness and conditions of the surface, if any, of the product.

Maximum errors allowed:

2. Instrument: The maximum allowed error is 1.0%, but it will not be less than 1 dm².

Other requirements:

3. Product presentation: If the product is backsliding or stopped, it shall not be possible to obtain a measurement value or the visual indication displayed shall cease.

4. Step: The instruments must have a step of 1.0 dm². In addition, it shall be possible to have a step of 0,1 dm² for test purposes.

Chapter IV. Instruments for multidimensional measures:

Operating Conditions:

1.1 Value Interval: Dimensions within the range of values specified by the instrument manufacturer.

1.2 Minimum Dimension: The lower limit of the minimum dimension for all the values of the step is shown in Table 1.

Table 1

Escalon (d)

50 d

Minimum dimension (min) (lower limit)
d ≤ 2 cm	10 d
2 cm < d ≤ 10 cm	20 d
	50 d

1.3 Product Speed: The speed must be within the range of values specified by the manufacturer for the instrument.

Maximum error allowed:

2. Instrument: The maximum allowed error is ± 1.0 d.

ANNEX XIV

Essential requirements specific to exhaust gas analyzers

The relevant applicable requirements of Annex IV, the specific requirements of this Annex and the conformity assessment procedures laid down in Article 6 apply to exhaust gas analysers. defined below that are intended for the professional inspection and maintenance of motor vehicles in circulation.

Definitions

Exhaust Gas Analyzer: An exhaust gas analyser is a measuring instrument that serves to determine the volume fractions of the specified components of the exhaust gases of the engines of the vehicles. Spark ignition engine for the humidity level of the sample tested.

Such gaseous components are carbon monoxide (CO), carbon dioxide (CO₂), oxygen (O₂), and hydrocarbons (HC).

The hydrocarbon content should be expressed as concentration of n-hexane (C₆ H₁₄) measured with near-infrared absorption techniques.

The volume fractions of the components of the gases are expressed as a percentage (% vol) for CO, CO₂ and O₂ and parts per million (ppm vol).

In addition, an exhaust gas analyser calculates the lambda value from the volume fractions of the exhaust gas components.

Lambda: Lambda is an dimensionless value that represents the combustion efficiency of an engine in terms of air/fuel ratio in exhaust gases. It is determined by a normalized reference formula.

Specific requirements

Instrument classes:

1. Two classes, 0 and 1, of instruments are defined for exhaust gas analyzers. The minimum metric ranges for those classes are those listed in Table 1.

Table 1. Measurement classes and ranges

Parameter	Classes 0 and 1
Fraction	From 0% vol to 5% vol.
2 Fraction	From 0% vol to 16% vol.
From 0 ppm vol to 2000 ppm vol.
Fraction of O2	From 0% vol to 21% vol.
λ	0.8 to 1.2.

Nominal operating conditions:

2. The manufacturer shall specify the values of the nominal operating conditions as follows:

2.1 For influence, climate and mechanical measures:

A minimum temperature range of 35 ° C for the climate environment.

The applicable mechanical environment class is the M1.

2.2 For the influence of electrical energy:

The voltage and frequency intervals for AC supply.

The limits of the power supply voltage continues.

2.3 For environmental pressure:

The minimum and maximum environmental pressure values are for both classes: pmin ≤ 860 hPa, pmax ≥ 1060 hPa.

Maximum errors allowed:

3. Maximum allowable errors are defined below:

3.1 For each of the measured fractions, the value of the maximum error allowed under nominal operating conditions according to point 1.1 of Annex IV is the largest of the two values shown in Table 2. absolute are expressed in% vol or ppm vol, the percentage values being the percentage of the actual value.

Table 2. Maximum errors allowed

Parameter

Class 0	Class I
	± 0.03% vol ± 5%	± 0.06% vol ± 5%
	Fraction CO2	± 0.5% vol ± 5%	± 0.5 % vol ± 5%
Fraction	± 10 ppm vol ± 5%	± 12 ppm vol ± 5%
Fraction of 02	± 0.1% vol ± 5%	± 0.1% vol ± 5%

3.2 The maximum error allowed in the lambda calculation is 0.3%. The conventionally true value is calculated according to the following formula:

where:

[] = concentration in% vol.

K1 = conversion factor of the NDIR measure to the FID measure (facilitated by the measurement equipment manufacturer)

H_cv= hydrogen/carbon atomic ratio [1,7261]

O_cv = oxygen/carbon atomic ratio [0.0175]

To this end, the values presented by the instrument are used for the calculation.

Allowed effect of perturbations:

4. For each of the volume fractions measured by the instrument the critical value of change is equal to the maximum error allowed for the affected parameter.

5. The effect of an electromagnetic disturbance will be such that:

the change in measurement does not exceed the critical change value defined in point 4, or

the indication of the result of the measurement cannot be interpreted as a valid result.

Other requirements:

6. The resolution must be equal to or of an order of magnitude greater than the values shown in Table 3.

Table 3. Resolution

		CO	CO,	O,	HC
Class 0 and class I.	0.01% vol.	0.1% vol.	*	1 ppm vol.

* 0,01% vol for measured values less than or equal to 4% vol and 0,1% vol for the remainder.

The lambda value must be displayed with a resolution of 0.001.

7. The standard deviation of 20 measurements shall not exceed one third of the absolute value of the maximum permissible error for each applicable gas volume fraction.

8. To measure CO, CO₂ and HC, the instrument including the gas control system specified above shall indicate 95% of the final value as determined by the calibration gases within 15 seconds. following the change from a zero content gas, for example fresh air. To measure the O₂, the instrument, under similar conditions, must indicate a value that differs from zero in less than 0,1% vol, within 60 seconds of the change of fresh air to an oxygen-free gas.

9. The components of the exhaust gases other than the component measuring objects shall not affect the result of the measurement by more than half of the absolute values of the maximum permissible errors, when those components are present as maximum in the following volume fractions:

6% vol CO,

16% vol CO₂,

10% vol Or₂,

5% vol H₂,

0.3% vol NO,

2000 ppm vol HC (as n-hexane),

Water vapor: to saturation.

10. An exhaust gas analyser shall have an adjustment device for the operation of adjustment to zero, gas calibration and internal adjustment. This device shall be automatic for adjustment to zero and internal adjustment.

11. In the case of automatic or semi-automatic adjustment devices, the instrument shall prevent a measurement from being carried out until the adjustments have been completed.

12. An exhaust gas analyser shall detect hydrocarbon residues in the gas handling system. It shall not be possible to carry out a measurement if the hydrocarbon residues present before a measurement is greater than 20 ppm vol.

13. An exhaust gas analyser shall have a device to allow for the automatic detection of any defective operation of the oxygen channel sensor due to wear or tear on the connecting line.

14. In case the exhaust gas analyser can be operated with different fuels (e.g. petrol or liquefied gas), the appropriate coefficients for the calculation of lambda without any ambiguity in relation to the formula should be selected. appropriate.

Conformity Assessment: The conformity assessment procedures referred to in Article 6 among which the manufacturer may choose are:

B + F or B + D or H1.

ANNEX XV

Identification of metrological control record inscriptions

1. Any entry in the Metrological Control Register as provided for in Article 22.1 shall be assigned an alphanumeric identification as follows:

where:

"XX" represent the two digits that identify the public administration that performs the registration, in accordance with the identification code list contained in Annex I.

"Y" is the letter that serves to identify the activity sector, according to the identification codes listed in Annex I.

"ZZZZ" are the four digits corresponding to the correlative number of records within each sector of activity, assigned by the public administration that carries out the enrollment.

"MM" are the two digits corresponding to the ordinal of the modification provided for in Article 27. They shall not be included in the initial registration.

2. Any entry in the Metrological Control Register as provided for in Article 22.2 shall be assigned an alphanumeric identification as follows:

where:

"XX" represent the two digits that identify the public administration that designated the body, in accordance with the identification code list contained in Annex I.

"WW" represent the type of organism: ON for notified bodies, OC for metrological control bodies and OV for authorised metrological verification bodies.

"ZZZZ" are the four digits corresponding to the correlative record number, assigned by the public administration that performs the enrollment.

"MM" are the two digits corresponding to the ordinal of the modification provided for in Article 27. They shall not be included in the initial registration.

3. Any entry in the Metrological Control Register as provided for in Article 22.3 shall be assigned an alphanumeric identification as follows:

where:

"XX" represent the two digits that identify the public administration that performs the registration, in accordance with the identification code list contained in Annex I.

"Y" is the letter that serves to identify the activity sector, according to the identification codes listed in Annex I.

"ZZZZ" are the four digits corresponding to the correlative number of records within each sector of activity, assigned by the public administration that carries out the enrollment.

"R" is the repair-specific identification.

"MM" are the two digits corresponding to the ordinal of the modification provided for in Article 27. They shall not be included in the initial registration.

If the person or entity to register as a repairer is already registered for another activity as referred to in Article 22.1, an independent and specific certificate shall be issued for the repair activity.