0/1992, of 26 November, of the Legal Regime of Public Administrations and of the Procedure Common Administrative.

It also has a derogation provision and six final provisions which refer, the first, to the title of competition for which the present royal decree is approved, the second to the development and modification of the the order of the Minister for Industry, Energy and Tourism, who is dependent, except as regards the harmonised legislation of the European Union, for the inclusion, exclusion or modification of the State's metrological control over measuring instruments Those referred to in Article 8.1 of Law 32/2014 of 22 December of Metrology, the third amend the contents of Royal Decree 584/2006 of 12 May, determining the structure, composition and functioning of the Metrology Council, the fourth is the non-increase in expenditure, the fifth lists the directives transposition object and the sixth sets the date of entry into effect.

The text includes sixteen attachments. Thus, Annex I refers to the conformity assessment procedures, Annex II refers to the essential requirements common to measuring instruments, with the exception of the non-automatic weighing instruments, the Annex III refers to the identification of markings, labels and seals, Annex IV regulates the legally relevant software, Annex V establishes a model of declaration of conformity and Annexes VI to XVI update the control regulation State metrology for instruments subject to European harmonisation regulation.

This provision has been submitted to the procedure for information on technical standards and regulations provided for in Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 on provides for a procedure for the provision of information in the field of technical regulations and rules relating to the services of the information society and in Royal Decree 1337/1999 of 31 July on the provision of information in the field of The subject of technical standards and regulations and regulations relating to the services of the company the information.

In its virtue, on the proposal of the Minister of Economy and Competitiveness, by the Minister of Industry, Energy and Tourism, with the prior approval of the Minister of Finance and Public Administrations, according to the Council of the State and after deliberation by the Council of Ministers at its meeting on 3 June 2016,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This royal decree aims at the development of chapters II, III and V of Law 32/2014 of 22 December of Metrology, which regulate, respectively, the Legal System of Units of Measure, the metrological control of the State and the organization of metrology.

Article 2. Definitions.

The International Metrology Vocabulary, published by the International Bureau of Weights and Measures, should always be used. In addition, for the purposes of the application of this royal decree,

following definitions shall apply:

(a) "Accreditation" means a declaration by a national accreditation body that a conformity assessment body or an authorised metrological verification body complies with the requirements laid down in accordance with standards; harmonised and, where appropriate, additional requirements, including those laid down in the relevant sectoral schemes, for the exercise of specific assessment activities established in this royal decree or in specific regulation.

(b) "Economic agents" means the manufacturer, the authorised representative, the importer and the distributor.

c) "Calibration": an operation that under specified conditions establishes, in a first stage, a relationship between the values and their associated measurement uncertainties obtained from the measurement patterns; and corresponding indications with their associated uncertainties and, in a second stage, uses this information to establish a relationship that allows a measurement result to be obtained from an indication.

(d) "Certificate of conformity" means a document issued by a notified body or a metrological control body, in relation to an instrument or system of measurement stating that it is in conformity with the common essential requirements; and specified in the metrological regulation applicable to it for placing on the market and putting into service.

(e) "Certificate of verification" means a document issued by an authorised metrological verification body in relation to an instrument or system of measurement stating that it is in conformity with the requirements laid down in the specific regulation applicable to it, this certificate may be of periodic verification or verification after repair in the light of the action taken.

(f) "accuracy class" means a class of measuring instruments or systems that satisfy certain metrological requirements intended to maintain measurement errors or instrumental uncertainties within specified limits; under given operating conditions.

(g) "Marketing" means any supply, paid or free, of a measuring instrument for distribution or use on the European Union market in the course of a commercial activity.

h) "State metrological control": a set of activities that contribute to ensuring the certainty and correction of the results of the measurements, regulating the characteristics of the instruments, means, materials reference, measurement systems and software related to the measurement, the appropriate procedures for their use, maintenance, assessment and verification, as well as the typology and obligations of the intervening agents.

i) "legal metrological control" means the control of the measurement tasks envisaged for the scope of an instrument of measurement, for reasons of public interest, public health, public order, environmental protection, tax and tax collection, consumer protection and loyalty of business practices.

(j) EU declaration of conformity, a written document by which the manufacturer or his authorised representative established in the European Union declares that the marketed product satisfies all the essential requirements of the various Application directives.

k) "Designation" means authorization by the competent Public Administration, recognizing a body or natural or legal person, the right to perform the specific tasks of the notified bodies, of control metrological or authorized metrological verification, once the procedure provided for in this royal decree has been complied with.

l) "Distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who markets an instrument or system of measurement.

m) "norm Administrations, regulating the reporting obligations to and from the Cooperation Agency. Administrative and in the bosom and among the members of the Commission of Legal Metrology of the Council of Metrology and, finally, in the third section is regulated the Register of Metrological Control.

Chapter V, "Notified bodies, metrological control and metrological verification", includes Articles 52 to 68 and refers to the system of habilitation and incompatibilities of notified bodies, of metrological and authorised metrological verification.

This royal decree has three transitional provisions, which refer to the term of validity of pre-existing conformity assessment certificates for entry into force, to the applicable deadlines for the adaptation of the Metrological control bodies and authorized metrological verification to the provisions of this royal decree and references to Law 3idence in the measurement result.

at) "Withdrawal" means any measure intended to prevent the placing on the market of a measuring instrument found in the supply chain.

(au) "Subset" means a 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 measuring instruments with which it is compatible.

av) "Metrological traceability": ownership of a measurement result by which the result can be related to a reference by an uninterrupted and documented chain of calibrations, each of which contributes to the measurement uncertainty.

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

ax) "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 has maintained since its last verification or, in the case of the first periodic verification, since its entry into service, the metrological characteristics applicable to it, in particular as regards the maximum permissible errors, as well as works according to its design and according to its specific regulation and, where applicable, the approved design or model.

CHAPTER II

Measure Units Legal System

Article 3. Traceability, accuracy and uncertainty of measurement patterns and instruments.

1. In accordance with the provisions of Chapter II of Law 32/2014 of 22 December 2014 on Metrology, the Legal System of Units of Measure is the International System approved by the General Conference of Weights and Measures instituted by the Convention of Paris of May 20, 1875.

2. The Spanish Metrology Center is responsible for the realization, materialization and dissemination of the units of measurement, at the highest metrological level, with the highest accuracy and the least uncertainty that allows the state of science. In accordance with Article 17.2 of Law 32/2014 of 22 December, of Metrology, and for reasons of scientific and technical specialization, the laboratories associated with the Spanish Metrology Center, designated by royal decree, are part of the national metrological structure and are responsible for the realization, materialization and dissemination of the units of measurement that have been assigned to them.

3. The metrological traceability of a measurement result shall be ensured through an uninterrupted, hierarchical and documented chain of calibrations, each of which contributes to the uncertainty of measurement, with respect to patterns of measurement that the units of the International System or another whose use is legally admitted in Spain for the specific magnitude and scientific field. Metrological traceability should always be referred to the International System or officially admitted system and, if they exist, to national or international standards in accordance with the international guidelines, standards or agreements adopted or subscribed by the Spanish Metrology Centre or the national accreditation body.

4. The Spanish Metrology Center and associated laboratories can guarantee traceability to the International System by any of the following ways:

a) By a primary realization or representation of the corresponding unit of measure.

(b) Through another national institute of metrology or designated institute, signatory to the Mutual Recognition Agreement of the International Committee of Weights and Measures that has recognized the capacity of measurement and calibration, with its declared uncertainty, published in the database of the International Bureau of Weights and Measures.

c) By means of the calibration services of the International Bureau of Weights and Measures.

(d) Exceptionally, when the above systems cannot be applied, alternative solutions may be established in accordance with the recommendations of the Advisory Committees of the International Committee on Weights and Measures. These solutions, in order to have legal relevance, must be approved by the Commission of Associated Laboratories of the Superior Council of Metrology.

5. The calibration and testing laboratories, the notified bodies, metrological control and metrological verification (s) and the inspection entities (when they carry out measurements in their determination activity) are accredited by the national accreditation body, should ensure that they maintain metrological traceability to national or international standards of measurement.

6. They shall be presumed to be in conformity with metrological traceability for physical, chemical or biological quantities, respectively, measurements made in accordance with UNE-EN ISO/IEC 17025 or UNE-ISO Guide 34 in force. The microbiology shall obtain a presumption of traceability from other internationally recognised sources.

7. Presumption of metrological traceability to the International System for physical and, or chemical, measurements made by:

(a) The Spanish Metrology Centre and the associated laboratories or, instead, National Institutes of Metrology and Designated Institutes whose recognised services and capacity of measurement are covered by the Agreement Mutual Recognition of the International Committee on Weights and Measures and published in the database to this effect, maintained by the International Bureau of Weights and Measures.

(b) calibration laboratories accredited by the national accreditation body or by other accreditation bodies which are signatories to the Multilateral Mutual Recognition Agreement which are incorporated in their scope of accreditation of the measuring and calibration capacity for the magnitude of which traceability is required provided that the reference and working patterns used at the first level of the hierarchical chain have a calibration certificate issued by the Spanish Centre of Metrology or by an associated laboratory or, failing that, by an Institute National of Metrology or a Signatory Designated Institute of the Mutual Recognition Agreement of the International Pesses and Measures Committee.

8. To obtain the uniformity and credibility of their measurements, the patterns, equipment and measuring instruments used in calibrations and tests that may have legal relevance, including those of legal metrology and conformity assessment, as equipment used for measures of auxiliary conditions and parameters which have a significant effect on the accuracy or validity of the ifting of seals, of a measuring instrument.

(ar) "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 specific.

(as) "Essential Requirements" means 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 parties concerned to have confents. This phase is established, for each instrument under control, either as a transposition of a European Directive that approves harmonised legislation or by specific Spanish legislation for the instruments of measure not regulated by the Union. European.

2. The metrological control of the State of the measuring instruments in service may include verification after repair or modification and, or periodic verification. A ban on the repair of certain measuring instruments can also be established and their life fixed for a maximum period of time.

Article 8. Competence and enforcement.

1. In accordance with Article 15 of Law 32/2014 of 22 December 2014 on Metrology, autonomous communities with powers for the execution of State metrological control shall be responsible for the compliance with the provisions of Chapter III of the the same. The competencies corresponding to the General Administration of the State will be exercised by the Ministry of Industry, Energy and Tourism through the Spanish Metrology Center.

2. In particular, it is up to the Public Administrations responsible for the implementation of State metrological control:

(a) Designate bodies to be notified and, where appropriate, the metrological control bodies and authorised metrological verification bodies, referred to in Article 19 of Law 32/2014, of 22 of December, of Metrology requesting authorization in the territory of its jurisdiction. These designations will be valid throughout the national territory.

b) Suspend, modify, or withdraw the designations of the bodies by them.

(c) Disable, in the cases provided for in Article 20, the measurement instrument repairers whose rating corresponds to them.

(d) To monitor and monitor the actions of the bodies and repairers operating in their territory; to process the sanctioning procedures and to impose, where appropriate, the penalties that correspond and to communicate the actions to the rest of the competent authorities, in particular to which the body designated the body, registered or received the responsible declaration described in Article 20 and the Spanish Metrology Centre, as a body of cooperation administrative.

e) To ensure that the instruments subject to the metrological control of the State which are placed on the market, installed or used in their territory have the corresponding markings, assessment and declaration of conformity, are up to date of the verifications which are applicable to them, function correctly, have not been violated or unduly altered and, in general, maintain the metrological characteristics, in the technical and legal orders necessary for their good operation.

f) Cooperating with the set of competent Public Administrations, within the Metrology Superior Council, for the smooth functioning of State metrological control throughout the national territory.

g) To comply with the provisions of this royal decree, in the applicable specific regulation and in the technical and coordination guidelines that, if necessary, emanate from the Superior Council of Metrology.

3. The designation of bodies shall be carried out in accordance with the provisions of Article 62 and the Guidelines of the High Council of Metrology referred to in Article 16.2 of Law 32/2014 of 22 December 2014 on Metrology. In particular, for the designation of notified bodies, the capacity of which is extended to the whole of the European Union, it shall act in accordance with the provisions of European legislation.

4. The activities related to the conformity assessment procedures for measuring instruments, with harmonised regulation of the European Union, shall be carried out by the notified bodies.

5. Activities related to conformity assessment procedures in application of a national specific regulation, i.e. the measuring instruments for which there is no harmonised European regulation, will be carried out by the Competent authorities or, where appropriate, the metrological control bodies which have been designated.

6. The activities relating to the periodic verification procedures or after repair or modification shall be carried out by the competent authority or, where appropriate, by the authorised metrological verification bodies which have been designated.

Section 3. Phase of Compliance Assessment

Article 9. Common and specific essential requirements for conformity assessment.

1. The essential requirements to be met by measuring instruments, subject to State metrological control, shall be as set out in Annex II and in the specific regulation applicable to each measuring instrument.

2. The conformity of a measuring instrument with the essential requirements shall be carried out in accordance with the conformity assessment procedures laid down in general and with which it is determined specifically for each instrument.

Article 10. Assessment of compliance.

1. The assessment of the conformity of a measuring instrument with the essential requirements of the harmonised application EC and, where appropriate, in application of a national regulation, shall be carried out, at the choice of the manufacturer, one or more of the the assessment procedures referred to in paragraph 2 of this Article and which are determined in the specific regulation of the measuring instrument.

2. The modules used for conformity assessment, which are developed in Annex I or in the relevant specific regulation, are as follows:

a) Module A, internal control of production.

b) Module A1, internal control of the most supervised production of the instruments.

c) Module A2, internal control of production plus monitored control of instruments at random intervals.

d) Module B, type examination.

e) Module C, compliance with type based on internal control of production.

f) Module C1, according to the type based on the internal control of the most supervised production of the instruments.

g) Module C2, compliance with the type based on internal control of the production plus monitored control of the instruments at random intervals.

h) Module D, compliance with the type based on quality assurance in the production process.

i) Module D1, quality assurance of the production process.

j) Module E, compliance with the type based on the quality assurance of the instrument.

k) Module E1, quality assurance of inspection and testing of the finished instrument.

l) Module F, compliance with type based on instrument verification.

m) Module F1, compliance based on instrument verification.

n) Module G, compliance based on unit verification.

n) Module H, compliance based on full quality assurance.

o) Module H1, compliance based on full quality assurance plus the design exam.

Section 2. Fases and execution of State metrological control

Article 7. Phases of State metrological control.

1. The assessment phase of the State's metrological control shall apply to measuring instruments with a view to their placing on the market and putting into service, using conformity assessment procedures. laid down in Article 10.2 and developed in Annex I or in the specific regulation of measuring instrumance 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 of Instruments of Measure of Directive 2014 /32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the marketing of measuring instruments (recast) and the references of which have been published in 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 relating to those parts of the regulatory document shall be presumed to be instrument meets.

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 must correctly and correctly apply the defined solutions either in the relevant harmonised European standards or in the relevant parts of the regulatory documents. referred to in paragraphs 1 and 3 above.

6. Compliance with the tests referred to in Article 13.3 (i) shall be presumed if they have been implemented in accordance with a programme in accordance with the relevant documents referred to in paragraphs 1 to 5 of this Article and their results. ensure compliance with the essential requirements.

Article 15. Declaration of compliance.

1. The EU and national declarations of conformity shall affirm that compliance with the essential requirements applicable to them has been demonstrated. The manufacturer when drawing up a declaration of conformity shall assume responsibility for the conformity of the measuring instrument with the requirements that apply to it.

2. The EU and national declarations of conformity shall conform to the model set out in Annex V, contain the elements specified in the relevant modules set out in Article 10.2 and shall be continuously updated.

3. Where a measuring instrument is subject to more than one European Union regulation requiring an EU declaration of conformity, a single declaration shall be drawn up in respect of all such acts of the European Union. This declaration shall contain the identification of the corresponding regulations and their publication references.

Section 4. Metrological Control Phase of Instruments in Service

Article 16. The metrological control of the State during the useful life of a measuring instrument.

1. The specific regulation of a measuring instrument subject to the State's metrological control may lay down the requirement for its periodic verification and, or, for verification after repair or modification.

2. In the cases determined by Article 8.3 of Law 32/2014 of 22 December 2014 on Metrology, the specific regulation of the measuring instrument may provide for a maximum period of service life. Different periods of life may be established for measuring instruments which, for the same purpose, use different technologies. For this purpose, the best technical forecast and, if any, the experience of the duration of the equipment, their use and the foreseeable drift to the measure shall be taken into account. The labelling and marking systems of these measuring instruments are set out in Annex III.

3. The prohibition on the repair or modification of measuring instruments may also be established. This prohibition may only be established for measuring instruments for which the obligation to carry out periodic verification is not regulated.

Article 17. Witness instruments.

1. In accordance with the provisions of Article 8.2 of Law 32/2014 of 22 December 2014 on Metrology, where this is determined in the specific regulation of each measuring instrument, the use of witness instruments, which shall be a the provision of citizens for the verification of measures taken by other measuring instruments which, belonging to more than one holder, are located in the same enclosure.

2. The control instruments shall be located in an easily identifiable enclosure as such and shall be used exclusively for citizens to be able to confirm the accuracy of the measures taken with the rest of the measuring instruments located in the enclosure.

3. The ownership of the witness instrument, under any of the formulae referred to in Article 19, may not be exclusively one of the holders of measuring instruments with commercial activity in the premises.

4. In accordance with point 3, holders of measuring instruments with commercial activity in the premises may have a witness instrument provided that they establish a maintenance contract with a trained undertaking and the responsibility for carrying out its periodic verification and, where appropriate, after repair, is contractually delegated to it. The competent authorities in the execution of State metrological control shall ensure strict compliance with the requirements and avoid cases of abuse or fraud.

5. The specific regulation of each measuring instrument, where it permits the use of control instruments, shall establish the metrological characteristics of the instruments and their periodic verifications and, or, after repair or modification. You can also set requirements on the location and accessibility of the token instrument and on the information for use that will be displayed to users.

6. Where there is a witness instrument, the period of periodic verification of measuring instruments in the enclosure where it is located may be extended by its specific regulation.

Article 18. Essential requirements and verification procedures.

1. The essential requirements that a measuring instrument must meet from its commissioning will be those established by this royal decree and by its specific regulation.

2. The conformity of a measuring instrument with the applicable essential requirements shall be assessed in accordance with the verification procedures laid down in its specific regulation, which shall cover in addition to the metrological requirements, technical and administrative procedures 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 measuring instrument, are consider necessary.

Article 19. Bound subjects.

Those who use or hold, for the purposes of property, leasing or other similar formulae, an instrument of measure in service for the purposes referred to in Article 6.1, shall be obliged to submit it to their verification in the situations or periods to be established in their specific regulation to determine the subject under each case.

Article 20. Repairers.

1. The repair or modification of the measuring instruments subject to metrological control of the State shall be carried out by the persons or entities which have submitted the responsible decfficial Journal of the European Union. Also, where applicable, in national legislation for instruments of non-harmonised legislation and in the guidelines and guidelines referred to in Article 41.

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

3. Compliance with the essential requirements to be determined in accordndicated in its specific regulation. The applicant for the conformity assessment shall provide the technical documentation and materials necessary for its assessment.

Article 24. Conformity marking.

Exceeded the conformity assessment of a reference material, which is the subject of this section, the conformity of the material to perform its function shall be recorded by attaching a label to a visible place of the packaging which must to meet the characteristics and requirements to be laid down in its specific regulation. The corresponding certificate of conformity shall also be issued.

Section 6. First Obligations of Economic Agents

Article 25. Obligations of manufacturers.

1. When placing their measuring instruments under metrological control of the State on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements which they require. they are applicable to those set out in Annex II and in their specific regulation.

2. Manufacturers shall draw up the technical documentation referred to in Article 13 and shall apply or mandate the application of the relevant conformity assessment procedure between those referred to in Article 10 (2) and shall be established for each type of measuring instrument in its corresponding specific regulation.

Where, by means of that conformity assessment procedure, it has been demonstrated that a measuring instrument complies with the applicable requirements, manufacturers shall draw up a declaration of conformity, based on the model that is includes in Annex V, and shall affix the marking which may correspond to those referred to in Annex III.

3. Manufacturers shall keep the technical documentation and the declaration of conformity for 10 years after the introduction of the measuring instrument on the market.

4. Manufacturers shall ensure that there are procedures for serial production to maintain their conformity with the provisions of this royal decree. Changes in the design or the characteristics of the measuring instrument and changes in the harmonised standards, regulatory documents or other technical specifications under which it is declared shall be duly taken into account. compliance.

Whenever it is considered appropriate for the operation of a measuring instrument, manufacturers shall test samples of the measuring instruments placed on the market, investigate and, if necessary, maintain a registration of complaints, non-compliant measuring instruments and recoveries of measuring instruments, and shall keep distributors informed of all monitoring in this respect.

5. Manufacturers shall ensure that the measuring instruments which they have placed on the market bear a type, batch or serial number or any other element enabling their identification or, if the size or nature of the measuring instrument it does not allow for the information required to be contained in a document accompanying the measuring instrument and on the packaging, if any, in accordance with the provisions of Article 12.2 of Annex II.

6. Manufacturers shall indicate in the measuring instrument, their name, registered trade name or registered trade mark and their postal address of contact or, where this is not possible, a document accompanying the measuring instrument and on its packaging, if which exists as determined in Article 12.2 of Annex II. The address shall indicate a single place where the manufacturer can be contacted. The contact details will be displayed in Spanish and, if appropriate, in the official languages of use in Spain, in order to facilitate their understanding of the final consumers and market surveillance authorities.

7. Manufacturers shall ensure that the measuring instrument which they have placed on the market is accompanied by a copy of the declaration of conformity, except for the instruments referred to in Annex VI, and instructions and information, indicated in this royal decree, in Spanish and, if applicable, additionally in the official languages of use in Spain, to facilitate their understanding to the final consumers. Such instructions and information, as well as any labelling, shall be clear, comprehensible and intelligible.

8. Manufacturers who consider or have reason to believe that a measuring instrument which they have placed on the market is not in conformity with this royal decree or with their specific regulation shall immediately take the necessary corrective measures. to be compliant, to withdraw it from the market or to recall it, if necessary. In addition, where the measuring instrument presents a risk, manufacturers shall immediately inform the competent, national or European authorities accordingly, and provide details, in particular, of non-compliance and of the corrective measures taken.

9. On the basis of a reasoned request from a competent public administration, manufacturers shall provide all necessary information and documentation, in paper or electronic form, to demonstrate the conformity of the measuring instrument with the established in this royal decree, in a language easily understood by that authority. They shall cooperate with that authority, at their request, in any action to avoid the risks posed by the measuring instruments which they have placed on the market.

10. For non-automatic weighing instruments which are not intended for use in the applications referred to in Article 1 (2) (a) to (f) of Annex VI, paragraphs 1, 2, 3, 4 (2) shall not apply. paragraph) and 7.

Article 26. Obligations of authorised representatives.

1. Manufacturers may, by means of a written mandate, designate an authorised representative. The obligations laid down in Articles 25.1 and the obligation to draw up technical documentation as determined in Article 25.2 may not be taken up by the authorised representative.

2. The authorised representatives shall carry out the tasks specified in the mandate received from the manufacturer. The command must allow the authorized representative to perform at least the following tasks:

(a) maintain the declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for a period of 10 years after the introduction of the measuring instrument into the market.

(b) on the basis of a reasoned request from the competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the measuring instrument.

(c) cooperate with the competent authorities, at their request, in any action to eliminate the risks posed by the measuring instruments that are the subject of their mandate.

Article 27. Obligations of importers.

1. Importers shall only enter into the market compliant measuring instruments.

2. Before placing a measuring instrument on the market or putting it into service, importers shall ensure that the manufacturer has carried out the proper conformity ass5. First Reference Materials

Article 22. Essential requirements for the conformity assessment of the reference materials.

The essential requirements to be met by reference materials submitted to the State's metrological control shall be those laid down in their specific regulation.

Article 23. Assessment of compliance.

The assessment of conformity with the essential requirements of a reference material shall be carried out in accordance with the assessment procedures iet with its trade name or trade mark or modify an instrument of measure which has already been placed on the market in such a way that its conformity with the provisions of this royal decree may be affected.

Article 30. Identification of economic operators.

1. Upon request, the economic operators shall identify with the market surveillance authorities:

(a) any economic operator who has provided them with a measuring instrument,

(b) to any economic operator to whom they have provided a measuring instrument.

2. Economic operators shall be capable of presenting the information referred to in point 1 of this Article for 10 years after they have been supplied with the measuring instrument and for 10 years after they have supplied them. the measuring instrument.

Section 7. Surveillance and Inspection: Generalities

Article 31. Surveillance and Inspection.

The surveillance and inspection referred to in Article 10 of Law 32/2014 of 22 December of Metrology shall be aimed at verifying the compulsory use of the Legal System of Units of Measure and in the manufacture, placing on the market, putting into service and use of the measuring instruments are met the requirements stipulated in this royal decree and in the applicable specific regulations.

Article 32. Action of the Public Administrations.

1. In the field of their powers, the Public Administrations shall take the necessary measures to prevent the measuring instruments or parts thereof subject to the metrological control of the State which do not comply with the provisions laid down in this royal decree and in its specific regulation, are placed on the market, placed or continued in service, as appropriate.

2. The Public Administrations shall ensure the correct use of the Legal System of Measurement Units and that the adjustment of the average error of the instruments in service is at zero value.

3. The competent public authorities may at any time themselves check compliance with the legal and regulatory requirements laid down for measuring instruments subject to State metrological control. Surveillance and inspection actions may be initiated on an ex officio basis, per complaint, by collaboration agreements as part of an inspection plan or as a participation in campaigns at European, state or regional level.

4. The competent public authorities may at any time themselves check compliance with the legal and regulatory requirements laid down for notified bodies, the metrological control bodies, the bodies responsible for authorised for metrological verification or repairers. The verification may examine, inter alia, the following aspects: availability of the appropriate means to carry out their work and use during their actions, use of appropriate procedures, adequacy of the documents which give rise to the facts of the facts, the resources available to them for the number of work carried out and compliance with the system of incompatibilities provided for in Article 53.

5. Officials carrying out the inspection activities shall have the status of officers of the authority in accordance with the provisions of Article 10.2 of Law 32/2014 of 22 December 2014. When they consider it necessary in the course of their actions, they shall have access to the industrial, commercial and accounting documentation of the companies they inspect. In the exercise of their inspection duties, they may request the support, assistance, assistance and protection provided to them by any other authority or their agents, which shall be provided with it.

6. Each surveillance or inspection action shall be recorded in a report or in a report which may serve as a basis for the processing of the relevant 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, reference materials or entities on which the inspection took place, the phases of the metrological control concerned as well as any deficiencies and inobservances that have been detected.

7. The inspection authorities, for the purposes of knowledge by the other competent bodies of the Member States of the European Union and of the competent national public authorities, through the Spanish Metrology Centre, report on the inspection programmes they intend to carry out and their results.

Article 33. Obligation of cooperation.

1. Both the bodies of the public authorities, and the companies with public participation, official bodies, professional organisations and consumer organisations will, when required, provide the information to be given to them. request for the relevant inspection services.

2. Public entities and private companies are obliged to allow the access of the inspector personnel to the places, vehicles and facilities where the metrological control must be carried out, as well as to facilitate the practice of the operations that require.

3. Manufacturers, or those responsible for the marketing of a measuring instrument, as well as the holders of measuring instruments in service subject to the State's metrological control, are obliged to provide the inspection staff with their collaboration and all the necessary means for the exercise of its functions and in particular to provide and permit the reproduction of all kinds of information, data and documents on the items inspected and metrological controls carried out, allowing appropriate sampling or testing to be carried out and studies to be carried out in this way; how to practice any other legally admitted test.

4. Competent Public Administrations shall provide natural or legal persons subject to inspection with accurate information for the proper exercise of their rights.

Section 8. Market surveillance, control of instruments entering the market and safeguard procedure

Article 34. General requirements.

1. Competent Public Administrations shall organise and carry out market surveillance in the manner provided for in this Section.

2. Market surveillance shall ensure that the measuring instruments subject to this royal decree and regulation specify that, where they are used in accordance with the intended purpose or under conditions which can reasonably be foreseen and with an installation and a adequate maintenance, may pose a risk in relation to the protected public interest, or which for other reasons are not in conformity with the applicable requirements laid down therein, are withdrawn, prohibited or restricted to placing on the market or to use, and to inform the public, the competent public authorities and, in their case, to the European Commission and to the Member States.

3. The correct use of the Legal System of Measure Units, as referred to in Chapter II of Law 32/2014 of 22 December of Metrology, shall be understood as a protected public interest, the protection of public interirement laid down in Article 25 (6) and that they bear the inscriptions which they provide for (a) the requirement of Article 27 (3) is fulfilled and the importer has complied with

requirement of Article 27 (3

Article 29. Cases where the obligations of the manufacturers apply to importers and distributors.

It shall be considered as a manufacturer and shall therefore be subject to the obligations of the manufacturer in accordance with Article 25, an importer or distributor who places a measuring instrument on the mark other than the Member State which initiated the procedure under this Article shall without delay inform the European Commission and the other Member States. members of any measure which they adopt and any additional information concerning the non-conformity of the measuring instrument in question which they have at their disposal and, in the event of disagreement with the national measure taken, shall raise their objections. The Spanish authorities and the Administrative Cooperation Agency shall act diligently to comply with this obligation when they receive news of action in other States of the European Union.

7. In the case of measuring instruments subject to national legislation, the process shall be identical to that described in the previous paragraph but the competent public authorities shall inform the Administrative Cooperation Agency which shall distribute the information within the Legal Metrology Commission of the Higher Council of Metrology.

8. If, within three months, from the receipt of the information referred to in paragraph 4 of this Article, no Member State or the European Commission, in the case of measuring instruments subject to European harmonisation legislation, and no competent public administration or the Administrative Cooperation Agency, in the case of instruments of measure under national law, have any objection to an interim measure taken by a Member State or a Competent Public Administration, the measure shall be deemed justified.

9. Measures taken by a competent public administration shall have effect throughout the national territory.

10. Competent Public Administrations shall ensure that appropriate restrictive measures are taken without delay in respect of the measuring instrument or system in question, such as their withdrawal from the market.

Article 37. Safeguard procedure.

1. For instruments subject to European harmonisation legislation, the administrative cooperation body shall carry out the implementing acts of the European Commission determining that the national measure is or is not justified to the competent authorities through the Legal Metrology Commission of the Higher Council of Metrology.

2. If the national measure is considered justified, the competent public authorities shall take the necessary measures to ensure that the non-compliant measuring instrument is withdrawn from the market and shall inform the Cooperation Agency. Administrative authorities which in turn will report to the European Commission. If the national measure is not considered justified, the Public Administration in question will withdraw it.

3. For measuring instruments subject to national legislation, if, after the completion of the procedure laid down in Article 36 (3) and (4), objections are raised against measures taken by a competent public administration or if the The Administrative Cooperation Body considers that such measures are contrary to the applicable law, the Administrative Cooperation Agency shall without delay consult the relevant public authorities and the relevant economic operators, and proceed with the assessment of the measure to be applied, transmitting all the information collected to the Commission of Legal Metrology of the High Council of Metrology, which shall determine whether the measure applied is justified or not, communicating its decision to the competent public authorities and to the agent or economic agents involved.

4. If the measure applied by the competent public administration is considered justified, the other competent public authorities shall take the necessary measures to ensure that the instrument of non-conformity is withdrawn from the market, and shall report to the Administrative Cooperation Agency. If the measure applied is not considered justified, the competent public administration shall withdraw it.

Article 38. Measuring instruments that present a serious risk.

1. Competent Public Administrations shall ensure that measuring instruments that pose a serious risk requiring rapid intervention, including serious risks that do not cause immediate effects, are recovered or withdrawn, or that prohibit their placing on the market or use, and report without delay to the Administrative Cooperation Agency which shall transmit this information to the other competent public administrations within the Commission of Legal Metrology of the Higher Council of Metrology. In addition, if the instrument is subject to European harmonisation legislation, the Administrative Cooperation Agency shall also inform the European Commission and the other Member States. If they consider it necessary, they may otherwise destroy or otherwise use the instruments involving a serious risk.

2. The decision on whether or not a measuring instrument poses a serious risk shall be based on an appropriate risk assessment taking into account the nature of the hazard and the likelihood of occurrence. The possibility of obtaining higher levels of safety or the availability of other instruments that present a lower risk will not be sufficient reason to consider that a product poses a serious risk.

Article 39. Compliant measuring instruments that present a risk.

1. If, after an assessment in accordance with Article 36, the competent public administration finds that a measuring instrument, although in accordance with this royal decree, poses a risk to aspects of protection of the public interest, ask the economic operator concerned to take all appropriate measures to ensure that the instrument in question does not present that risk when it is placed on the market or to withdraw it from the market or to recall it within the time limit. reasonable, proportionate to the nature of the risk, to be determined by the public administration.

2. The economic operator shall ensure that the necessary corrective measures are taken in respect of all the measuring instruments concerned which the European Union has made available on the market.

3. The competent public administration shall inform the Administrative Cooperation Agency, who shall inform the other competent Spanish authorities within the Legal Metrology Commission of the Council of Metrology. In addition, if the instrument is subject to European harmonisation legislation, the Administrative Cooperation Agency shall also inform the European Commission and the other Member States. The information provided shall include all available details, in particular the data necessary to identify the instrument in question and determine its origin, the supply chain, the nature of the risk posed and the nature and duration of the measures taken.

4. In the case of instruments subject to European harmonisation legislation, the European Commission shall without delay consult the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of the assessment, it shall adopt a decision by means of implementing acts indicating whether the national measure is justified and, where appropriate, propose appropriate measures. The Commission shall immediately communicate its decision to all Member States and to the releve relevant economic operator. In particular, the competent public authorities shall indicate whether the non-conformity is due to the fact that the measuring instrument does not meet the requirements relating to the protection of the public interest protected under this royal decree or to there are deficiencies in the harmonised standards or in the regulatory documents referred to in Article 14 which attribute the presumption of conformity.

6. In the case of instruments of measure subject to European harmonisation legislation, Member Statesto provide for the implementation and maintenance of quality systems, the use of marks related to the Mutual Recognition Agreement, with organisations International metrology, with the Spanish Metrology Centre and the Associated Laboratories, the participation of the Associated Laboratories in the international metrological bodies, the mutual provision of calibration services and the cooperation in investment, in research and development projects and in training.

6. The Spanish Metrology Center can name a Collaborating Laboratory to those metrology laboratories belonging to companies or entities that use them for their economic activity and that have unique facilities of high cost. The appointment as a Collaborating Laboratory requires a favorable prior report from the Metrology Superior Council.

7. The relationship between the Spanish Metrology Center and the Collaborating Laboratory will be formalized through a convention. This agreement will at least regulate the capacity of the Spanish Metrology Centre to protect the implementation and maintenance of quality systems, the use of marks related to the Mutual Recognition Agreement, with the organizations International metrology, with the Spanish Metrology Center and the Associated Laboratories, the participation of the Collaborating Laboratory, through the Spanish Metrology Center, in international comparisons and the consequent access of the Spanish Metrology Center to obtain recognized capacity of measurement, the joint provision of services and collaboration in research and development projects.

Section 2. Notifying Authority and Cooperation between Administrations

Article 43. Notifying authority and cooperation and exchange of information.

1. The Ministry of Industry, Energy and Tourism is the notifying authority to the European Union.

2. The Spanish Centre for Metrology, as the Agency for Administrative Cooperation, shall collaborate with the notifying authority for the exchange of information with the other bodies designated for this purpose by the other States. Member States of the European Union and the European Commission, as well as with the competent public authorities, in relation to the procedures for the assessment of conformity and market surveillance of instruments subject to control State metrological. In particular it shall be exchanged:

(a) Information on the results of the examinations and the degree of conformity with the applicable provisions of the measuring instruments examined.

(b) EU type-examination certificates and EU design exams, with the annexes issued by Spanish notified bodies, as well as modifications, additions or revocations in relation to the certificates issued.

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

(d) Assessment reports prepared by notified bodies at the request of the Public Administrations.

3. 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 that they have designated.

4. The Administrative Cooperation Agency shall make available to the public authorities with competence in the field of metrology the information relating to the actions carried out by each of them in application of the regulation. national specific. For these purposes, in accordance with the provisions of Chapter V, these administrations shall inform the Administrative Cooperation Agency of their actions. In particular it shall be exchanged:

(a) Information on registrations, authorisations, modifications and withdrawals of notified bodies, metrological control bodies, authorised metrological verification bodies and repairers.

(b) Information on the results of the examinations and the degree of conformity with the applicable provisions of the measuring instruments examined.

c) Certificates of type and design examination, additional modifications or revocations.

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

e) Reports of conformity assessment prepared by metrological control bodies at the request of the Public Administrations.

(f) Reporting of surveillance and inspection actions carried out on measuring instruments and reference materials in the different stages of marketing, putting into service and use.

Section 3. The Metrological Control Record

Article 44. The Metrological Control Register.

The Register of Metrological Control, established in Article 18 of Law 32/2014, of December 22, of Metrology, is a single registry of national scope, whose data are centralized in the Spanish Center of Metrology of the which is dependent on the said register. The management of this register is the responsibility of the competent public authorities.

Article 45. Content.

The Metrological Control Record must include the following information:

(a) Data relating to natural or legal persons acting in the field of State metrological control, as set out in Article 18 of Law 32/2014 of 22 December 2014, of Metrology.

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

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

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

Article 46. Registration.

1. Natural persons or entities that manufacture, import, market or lease the instruments of measurement submitted to the State's metrological control shall be registered, by the appropriate Public Administration, in the Register of Metrological control when requesting any metrological operation.

2. Similarly, persons or entities involved in the established metrological control phases shall also be entered in the Metrological Control Register.

3. Natural or legal persons who repair measuring instruments subject to the State's metrological control shall be registered as a trade in the Metrological Control Register by the competent services of the autonomous community in which they have their registered office on the basis of the responsible statement submitted. Additionally, the competent services of the autonomous community may incorporate data from other sources into the Metrological Control Registry. Repairers domiciled in other Member States of the European Union, who are not required to present a responsible declaration, shall be registered by the first competent authority with knowledge of their activity.

Article 47. Data is entered.e) Collaboration in training and dissemination projects in the metrological field.

4. The Commission of Associated Laboratories of the Superior Council of Metrology is an organ of dialogue and exchange of information between the Spanish Center of Metrology and the Associated Laboratories.

5. The relationship between the Spanish Metrology Center and the Associated Laboratory will be formalized by means of a Convention. This Convention shall at least regulate the capacity of the Spanish Metrology Centre of measuring instruments subject to metrological control.

3. The Spanish competent authorities and, where appropriate, the national accreditation body shall ensure that these criteria are met. The Legal Metrology Commission of the Higher Council of Metrology may develop technical guidelines for the harmonized application of the incompatibilities regime provided for in this royal decree.

Article 54. Designation, suspension, withdrawal and modification of the conditions for the designation of the organisms.

1. The competent public authorities are responsible for the designation of notified bodies, metrological control and metrological verification, monitoring of the maintenance of their competence and the modification of the its conditions or scope and its suspension and withdrawal. The designation of the bodies referred to in the preceding paragraph shall be made in accordance with Article 62.

2. During the processing of the sanctioning and withdrawal procedures, the suspension of the authorisations governed by this royal decree may be agreed upon, where one of the circumstances set out in Article 64 is present.

The suspension of the designation will be effective automatically when the accreditation that served as the basis for the designation is suspended.

The suspension of the designation will imply the body's prohibition to continue to provide service. The competent public administration shall, in this regard, inform the Administrative Cooperation Agency. It shall, in turn, inform the other competent public authorities and, in addition, where the suspension relates to a notified body, to the notifying authority which shall forward this information to the Commission and to the other Member States. members.

3. Decisions of designation granted by the competent public authorities may be withdrawn or amended, either on their own initiative or at the request of a party, when any of the causes referred to in Article 64 are present. Prior to the initiation of the procedure, the holder shall be notified of the case which may result in the extinction or modification so that, where appropriate, the deficiencies are remedied. The procedure shall be substantiated and resolved by the Public Administration which granted the procedure, after having been instructed to the effect with the hearing of the person concerned in which the concurrency of the cause of withdrawal or modification is established. The resolution of the procedure shall be adopted and notified within the maximum period of six months.

In cases of total or partial withdrawal of the designation, the holder shall submit the documentation linked to his/her performance to the entity designated by the competent Public Administration. This Administration shall inform the Administrative Cooperation Agency of the said withdrawal and the latter shall, in turn, do so to the other competent public authorities and, in the case of a notified body, a notifying authority which transmit this information to the European Commission and the other Member States.

Article 55. Questioning the competence of organisms.

1. Where the European Commission questions the competence of a body notified by Spain, the notifying authority shall provide the European Commission, at its request, with all the information on which the notification or maintenance of the notified body is based. competence of the notified body concerned. To this end, the competent public authorities shall provide the Administrative Cooperation Agency with all the necessary cooperation and information. The Administrative Cooperation Agency may, by informing the appointing authority, collect from the body any relevant information and documentation.

2. Where the European Commission finds that a body notified by Spain does not comply or no longer meets the requirements of its notification and adopts an implementing act requesting the Spanish State to take the corrective measures necessary, which may consist, when deemed necessary, in the withdrawal of the notification, the notifying authority shall communicate this information to the Agency for Administrative Cooperation which shall, for its implementation, transfer it to the Administration He publishes that he has appointed him, who will register the executive act in the Metrological Control Registry.

3. The Administrative Cooperation Agency may, on its own initiative or at the request of an autonomous community, question the competence of a notified body, metrological control or metrological verification authorized by another administration. Public competent and collect information from the body directly or through the autonomous community that designated it. The competent autonomous communities shall provide the Administrative Cooperation Agency with all the necessary cooperation.

4. Where the Agency for Administrative Cooperation finds that a notified body, a metrological control or a metrological verification body designated by a Spanish Public Administration, does not comply or no longer meets the requirements necessary to continue to act, after a favourable report from the Higher Council of Metrology, to the autonomous community which designated it, to take the necessary corrective measures, which may consist, when deemed necessary, in the withdrawal of the authorization.

5. All administrations shall provide the means necessary to ensure the confidential treatment of all sensitive information collected in the course of their investigations.

Article 56. Accredited internal bodies.

1. An accredited internal body may be used to carry out conformity assessment activities for the undertaking of which it is a party for the purposes of applying the procedures laid down in Article 4 (Module A2) and Article 8 (module C2) of Annex I. That body shall constitute a separate and identifiable part of the undertaking and shall not participate in the design, production, supply, installation, use or maintenance of the measuring instruments which it has evaluate.

2. The accredited internal body shall be accredited in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008. The body and its staff shall be organised in an identifiable manner and shall use methods of information within the undertaking of which they form part which ensure their impartiality and demonstrate this to the national accreditation body. Neither the body nor its staff shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the measuring instruments which they assess, nor shall they carry out any activity which may conflict with its independence of criterion or integrity in relation to the assessment activities and shall provide its services only to the undertaking of which it is a party.

3. The accredited internal bodies shall not be notified to the Member States or to the European Commission, but the information relating to their accreditation shall be made available to the competent public authorities on request by the undertaking. of which it is a party or the national accreditation body.

t that the activities are carried out directly by a public administration or public ownership bodies and entities. It is also compatible when action as a notified body or a metrological control is limited to the completion of the F-module (conformity with the type based on the verification of the product) referred to in Article 10 (2) (l). 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.

2. Bodies may not subcontract tasks to repairers must meet the compatibility criteria. laid down in Article 53. Bodies notified to those belonging to a trade association or a professional federation may be considered to be involved in the design, manufacture, supply, assembly, use or maintenance of measuring instruments which evaluates, provided that it ensures its independence and the absence of conflicts of interest.

Article 59. Subsidiaries and subcontracting.

1. Bodies may subcontract tasks strictly limited to technical aspects, under no circumstances may they subcontract all their activities or those that consist in the performance of interpretations, judgments or assessments of conformity of individual requirements or acceptance or rejection of instruments. Subcontractors will not be able to cascade back up.

2. Any subcontracting requires an authorization from the Public Administration that has designated the agency.

3. Where the body subcontracts specific tasks relating to conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary complies with the requirements laid down in Article 58 and shall inform the authority that you have designated. It shall inform the Spanish Centre of Metrology and the Commission of Legal Metrology of the Council of Metrology and in the case of the notified bodies also to the notifying authority.

4. The body shall assume full responsibility for the tasks carried out by subcontractors or subsidiaries, irrespective of where they are based. Activities may only be subcontracted or delegated to a subsidiary, subject to the consent of the client. The body shall keep at the disposal of the designating authorities the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary, as well as of the work carried out by them in connection with the activities of the subcontractor. conformity assessment or verification assessment. In the case of notified bodies, the notifying authority may request this information through the designating authorities.

Article 60. Presumption of conformity of bodies.

1. If a notified body or a metrological control body demonstrates that it complies with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, complies with the requirements laid down in Article 58 in so far as the applicable harmonised standards cover those requirements.

2. The competent public authorities shall assess the technical qualification for access to, or to maintain, the status of a notified body, a metrological control body or an authorised metrological verification body in accordance with the Article 19 (2) of Law 32/2014 of 22 December 2014 on Metrology.

3. The assessment of the technical qualification by means other than the accreditation of the body may be carried out only if there are no accredited bodies at the state level for the evaluating or verifying function, either as a result of the The invention relates to a novel regulation which requires a time for obtaining accreditation, or for not having an interest in performing the function. In any case, the assessment of the technical qualification will be of a transitional nature and will require a prior report from the Commission of Legal Metrology of the Metrology Council.

4. Each year, the Public Administration, which has appreciated the extraordinary technical qualification provided for in the previous point, will have to carry out an assessment of whether the circumstances which served as a basis for that assessment persist. of this to the Commission of Legal Metrology of the Superior Council of Metrology.

Article 61. Request for designation.

1. Entities that wish to be designated as notified bodies, metrological control or metrological verification, shall request the competent Public Administration in the territory where they access the activity for which they they wish to be accredited, without prejudice, where appropriate, to the application of the provisions of the rules of origin in the additional provision of the 10th of the Law 20/2013 of 9 December 2013 on the guarantee of the market unit.

2. Applicants shall be public or private entities established in Spain which have the appropriate facilities, equipment and means necessary to carry out their activities.

3. The application for designation submitted shall include a description of the conformity or verification assessment activities, the conformity assessment module (s) or the verification type (s), the measuring instrument (s), and any other (s) possible. ranges of measure, if applicable, for which the body is considered competent, as well as a certificate of accreditation, if any, issued by the national accreditation body, stating that the body complies with the requirements laid down in Article 58 above, with the exception of the insurance requirement referred to in paragraph 11 of such an article, the subscription of which may be deferred at the time of the granting of the relevant authorisation.

4. Where the requesting body concerned is unable to provide an accreditation certificate, for the reasons set out in Article 60.3, it shall provide the designating authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of compliance with the requirements laid down in Article 58.

Article 62. Designation procedure.

1. Competent Public Administrations may designate only notified bodies, metrological control and metrological verification bodies which satisfy the requirements laid down in Article 58 above.

2. Those administrations shall decide in a reasoned manner on the request for designation to be made within the maximum period of six months from the date of submission of the application. In another case, the provisions of the second paragraph of Article 43.1 of Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, shall apply.

3. In the field of the General Administration of the State, the appointing authority is the General Secretariat of Industry and Small and Medium-sized Enterprises. Against their decisions, in this field, which will put an end to the administrative procedure, the parties concerned may bring the replacement of the General Secretariat for Industry and Small and Medium-sized Enterprises within one month, or challenge it directly in the face of the administrative-administrative jurisdictional order.

4. The designations of the notified bodies and metrological control bodies shall refer to complete modules for the conformity assessment of those referred to in Article 10.2 and to categories of measuring instruments and measuring fields, if appropriate.

5. The designations of the authorised metrological verification bodies shall relate to categories of measuring instruments and specific fields of measurement.

6. The designation shall include information on the type or types he Metrology Council in accordance with the specific legislation applicable at national level, shall ensure that its personnel responsible for carrying out the conformity assessment tasks are informed of this and shall apply the decisions and the decisions to the general guidelines. administrative documents emanating from the cited Legal Metrology Commission.

15. Notified bodies, metrological control and metrological verification bodies shall have a third independent part of the organisation or the measuring instrument which they assess andditation that served as the basis for the designation.

(c) Failure to comply with the requirements set out in this Royal Decree, as well as in existing legislation, where such non-compliance seriously undermines the quality of the services it provides or where the non-compliance is occurs repeatedly or dilated in time.

(d) Repeated non-compliance with the instructions given by the competent body in the field of metrology, where the quality of the services it provides or where the non-compliance occurs in a manner is seriously undermined. dilated in time.

(e) Failure by the holder of the obligation to maintain facilities and equipment in appropriate conditions of conservation and technical suitability, where such non-compliance seriously undermines the quality of the services that provide or place at risk the public interest protected.

f) Service interruption for unjustifiable causes in more than 10 consecutive days, 10 non-consecutive days within one month, or 30 non-consecutive days in the course of a year.

g) Extinction or loss of legal personality of the entity holding the body or death or declaration of incapacity of the natural person who is the holder of the body.

h) A substantial change in the material and functional requirements that founded the designation.

7. The following may be caused by suspension:

(a) The repeated failure to comply with the instructions given by the competent body for metrology.

(b) The refusal to accept conformity assessments or regulatory or agreed verifications by the competent body in the field of metrology, or the obstruction of its practice.

(c) Failure by the operator to comply with its obligation to maintain its facilities and equipment in appropriate conditions of conservation and technical suitability, where such non-compliance undermines the quality of the services to lend.

d) The suspension of the accreditation that served as the basis for the corresponding designation will involve the suspension of the designation automatically.

Article 65. Operational obligations of the notified bodies, metrological control and metrological verification.

1. The bodies shall carry out conformity assessments and verifications in accordance with the conformity assessment procedures laid down in Article 10.2 and the verification procedures specified in the specific regulation of each instrument or measurement system.

2. Conformity assessments and verifications shall be carried out in a proportionate manner, avoiding the imposition of unnecessary burdens on economic operators. The conformity assessment bodies shall carry out their activities taking due account of the size of the undertakings, the sector in which they operate, their structure, the degree of complexity of the product technology and whether the production process is serial.

However, they will respect the degree of rigor and the level of protection required for the instrument to comply with this royal decree and the specific regulation applicable to it.

3. If a notified body or metrological control body finds that the manufacturer does not comply with the essential requirements laid down in this royal decree, in the applicable specific regulation or in the relevant harmonised standards or other technical specifications, shall require the manufacturer to take appropriate corrective measures and shall not issue the certificate of conformity.

4. If, in the course of the follow-up to the conformity of the certificate, a body finds that the instrument is no longer compliant, it shall require the manufacturer to take the appropriate corrective measures and, if necessary, suspend or withdraw its certificate. If corrective action is not taken or the measures do not take the required effect, the notified body shall restrict, suspend or withdraw any certificate, as appropriate.

5. In general, the notified bodies, the metrological control and the metrological verification bodies shall comply with the following obligations:

a) Meet the conditions that served as the basis for your designation and, where applicable, accreditation.

(b) To tender the applications submitted to them, by issuing the protocols, minutes, reports, and, where appropriate, certifications that are required for them.

c) To provide services directly or indirectly related to the instruments and fields of measure in which they are entitled, to be entrusted to them in accordance with the instructions of the Administrations Competent public.

d) Carry records that record how many controls have been performed and all protocols, minutes, reports, and, where applicable, certifications that they issue in relation to them.

e) Keep the records, documentation and data of the checks carried out for your possible consultation, in paper or electronic form. Notwithstanding the foregoing, the dossiers relating to periodic verifications and verifications after repair or modification may be destroyed or removed after the expiry of the ten-year period since their issue.

Article 66. Review of the decisions of the agencies.

When a notified body, metrological control or metrological verification authority issues a protocol, minutes, report or certification with a negative result regarding compliance with the regulatory requirements, the The person concerned may complain that he is not in conformity with the body itself and, in the event of disagreement, with the competent authority. The Administration shall require the body to have the background and to carry out the checks which correspond to the person concerned in the manner provided for in Law No 30/1992 of 26 November of the Legal System of Public Administrations and of the Common Administrative Procedure, resolving within the time limit that the effect establishes, and failing to do so within three months, whether or not the control carried out by the body is correct. As long as there is no refusal by the Administration, the data subject may not request the same control of another notified body, metrological control or metrological verification.

Article 67. Reporting and collaboration obligations of the bodies.

1. The notified bodies and metrological control bodies shall immediately and without prior notice inform the Public Administration which designated them and the Administrative Cooperation Agency of any refusal, restriction, suspension or withdrawal of certificates, as well as any circumstances affecting the scope or conditions of their designation and any request for information on the conformity assessment activities which they have received from the market surveillance authorities or other competent and prior public administrations the application of the conformity assessment activities carried out within the scope of its action and any other activities carried out, including cross-border activities and subcontracting. In the case of notified bodies, the Administrative Cooperation Agency shall forward this informatiorred to in paragraphs 3 and 4 above, the holder shall forward to the competent public administration the documents of the amendment, as well as the documents concerned of which they have served as a basis for the designation, It shall, in turn, inform the Administrative Cooperation Agency.

6. The following may be causes for removal:

a) Failure to comply with the conditions that served as the basis for the designation.

b) Withdrawal by the national accreditation body of the corresponding accrefor the implementation and development of the provisions of this royal decree.

2. The Minister for Industry, Energy and Tourism is hereby authorised to update by order the contents of the Annexes, in order to keep them adapted to the progress of the technique and to European and international metrology standards.

3. The Minister for Industry, Energy and Tourism is also responsible for the specific regulations, in their various stages, on the metrological control of the measuring instruments referred to in Article 8.1 of Law 32/2014, of 22 December 2014. December, of Metrology.

Final disposition third. Amendment of Royal Decree 584/2006 of 12 May 2006 determining the structure, composition and functioning of the Metrology Board.

Article 7 of Royal Decree 584/2006 of 12 May 2006 determining the structure, composition and functioning of the Council of Metrology is read as follows:

" Article 7. The Legal Metrology Commission.

1. The Legal Metrology Commission is an organ of the Higher Council of Metrology constituted by the Presidency and the holders of the vocalias. The chair of the Legal Metrology Commission will be held by the management of the Spanish Metrology Centre. The persons designated for this purpose shall be the holders of the terms of the Commission as representatives of each of the autonomous communities and the cities of Ceuta and Melilla wishing to join it. For this purpose, the holder of the address of the Spanish Metrology Centre shall request the Consejeria or equivalent organ of each of the autonomous communities and cities of Ceuta and Melilla with powers to appoint, if appropriate, a representative. He shall also act as the person responsible for the Secretariat of the Commission, with the status of an official, at least level 29, of the Spanish Centre for Metrology, designated by the holder of his address.

2. It is up to the Legal Metrology Commission of the Superior Council of Metrology to report and propose to the plenary how many matters relate to the regulation of instruments, laboratories and agencies involved in the metrological control of the State. In particular, the Commission will report on the need and the opportunity to regulate instruments. In addition, it is the forum where the autonomous communities will inform the Technical Secretariat about the resources they can have for the implementation that corresponds to them in compliance with the aforementioned regulations. The Commission shall also periodically review the functionality of the Metrological Control Register and propose to the Technical Secretariat the improvement lines it deems necessary.

3. The Commission of Legal Metrology of the Higher Council of Metrology is an organ of dialogue, cooperation and exchange of information between the Spanish Center of Metrology and the competent administrations in the execution of the metrological control of the Status.

4. The authorities responsible for the execution of the State's metrological control are responsible for cooperating with each other and with the Spanish Metrology Center. Cooperation should be extended to all fields affecting the State's metrological control, and particularly to:

(a) The assessment of the specific regulations of the instruments submitted to the State's metrological control, solving the legal and technical problems of their implementation, proposing initiatives or informing regulatory provisions and drawing up the guidelines and guidelines referred to in Article 41.

(b) The exchange of information on the designations and action of notified bodies, metrological control bodies and authorised metrological verification bodies.

c) Communication on violations and sanctions committed in the territory of their jurisdiction.

d) Collaboration in market surveillance and inspection campaigns, avoiding duplication and coordinating actions.

e) Collaboration in training and dissemination projects in the field of legal metrology.

5. The Spanish Metrology Centre will provide its technical and legal support to the Legal Metrology Commission of the Metrology Council. "

Final disposition fourth. No increase in staff expenditure.

The measures included in this royal decree will be met with the ordinary budget allocations and will not be able to increase appropriations, remuneration, or other personnel costs, even in the form of allowances or travel expenses.

Final disposition fifth. Incorporation of European Union rules.

By this royal decree, Directive 2014 /31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the subject matter of the Spanish legal order is incorporated into Spanish law. for the placing on the market of non-automatic weighing instruments (recast), Directive 2014 /32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the marketing of measuring instruments (recast) and the Delegated Directive Commission Implementing Regulation (EU) 2015/13 of 31 October 2014 amending Annex III to Directive 2014 /32/EU of the European Parliament and of the Council as regards the flow rate for water meters.

Final disposition sixth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on June 3, 2016.

FELIPE R.

The Minister of Industry, Energy and Tourism,

P.S. (Royal Decree 160/2016, of 15 April),

The Minister of Economy and Competitiveness,

LUIS DE GUINDOS JURADO

ANNEX I

Compliance assessment procedures

Article 1. Generalities.

The modules for conformity assessment, which are developed in this annex, will be used, as appropriate, both for the application in the specific field of harmonised legislation at the level of the European Union and in the specific field of national law of application to measuring instruments and systems, except as specifically laid down in Appendix VII to Annex VI, which shall apply exclusively to the weighing instruments of operation not automatic.

In order to harmonise the terminology to be used in the different areas referred to in the preceding paragraph, it is understood that when talking about certificates, markings and declaration of conformity, it must be understood that each one refers to each one of the of the areas and therefore not specified in the description of the modules, in the same way the term organism refers both to the notified bodies and to the control bodies according to the scope of application.

Article 2. Module A: Internal production control.

1. The internal control of production is the conformity assessment procedure whereby tn-automatic weighing instruments.

Final disposition 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.

Final disposition second. Enablement for development and other authorizations for regulatory production.

1. The Minister of Industry, Energy and Tourism is enabled to dictate how many provisions are necessary he manufacturer fulfils the obligations set out in points 2, 3 and 4 of this Article, and ensures and declares, under his sole responsibility, that the measuring instruments in question satisfy the requirements of this royal decree that apply to them.

2. Technical documentation.

The manufacturer shall prepare the technical documentation in accordance with the provisions of Article 13 of this royal decree. This documentation shall make it possible to assess the conformity of the instrument with the relevant requirements and shall include an appropriate risk assessment and assessment. The technical documentation shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the instrument.

3. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the instruments manufactured with the technical documentation referred to in the previous point and with the requirements of this royal decree to be applied to it.

4. Conformity marking and declaration of conformity.

4.1 The manufacturer shall apply the markings prescribed in each case by this royal decree to each measuring instrument that satisfies the applicable requirements of the instrument.

4.2 The manufacturer shall draw up the declaration of conformity, which may correspond to the regulatory framework applied for each measuring instrument model and shall, together with the technical documentation, keep it available for the national authorities for a period of 10 years after the introduction of the measuring instrument on the market. That declaration of conformity shall identify the model of the instrument which is the subject of the instrument.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of the declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

5. Authorized representative.

The manufacturer's obligations set out in point 4 of this Article may be fulfilled, on his behalf and under his responsibility, by his authorised representative, provided that they are specified in his mandate.

Article 3. Module A1 Internal control of the most supervised production of the instruments.

1. The internal control of the production plus the supervised test of the instruments by an organism is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5 of this Regulation. guarantees and declares, under its sole responsibility, that the instruments in question satisfy the requirements of the legislative instrument that apply to them.

2. Technical documentation.

The manufacturer shall prepare the technical documentation in accordance with the provisions of Article 13 of this royal decree. Such documentation shall allow the assessment of the product's compliance with the relevant requirements and shall include an appropriate risk assessment and assessment.

The technical documentation shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the product. The technical documentation shall include, where appropriate, at least the following elements:

a) product overview,

(b) design and manufacturing plans, as well as the schemes of the components, subassemblies circuits, etc.,

(c) the descriptions and explanations necessary for the understanding of such plans and schemes and the operation of the product,

(d) a list of harmonised standards, regulatory documents or other relevant technical specifications, the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legal instrument in the event of the non-application of those harmonised standards. In the case of harmonised standards or regulatory documents to be applied in part, the parts that have been applied shall be specified in the technical documentation.

e) the results of the design calculations, controls performed, etc.,

f) the test reports.

3. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its supervision ensure the conformity of the manufactured instruments with the technical documentation mentioned at the point and with the requirements of this royal decree to be applied to it.

4. Product control.

For each product manufactured, one or more tests relating to one or more specific aspects of the measuring instrument shall be carried out by the manufacturer or on behalf of the manufacturer to verify compliance with the requirements corresponding to the legislative instrument. At the choice of the manufacturer, the tests are carried out either by an accredited internal body or under the responsibility of a notified body or metrological control, as appropriate, chosen by the manufacturer.

In case the tests are carried out by an organism, the manufacturer, under the responsibility of the notified body or the metrological control body, shall affix the identification number of the organism during the manufacturing process.

5. Conformity marking and declaration of conformity.

5.1 The manufacturer shall apply the markings prescribed in each case by this royal decree to each measuring instrument that satisfies the applicable requirements of the instrument.

5.2 The manufacturer shall draw up the declaration of conformity, which may correspond to the regulatory framework applied for each measuring instrument model and shall keep it, together with the technical documentation, at the disposal of the national authorities for a period of 10 years after the introduction of the measuring instrument on the market. That declaration of conformity shall identify the model of the instrument which is the subject of the instrument.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of the declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

6. Authorized representative.

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

Article 4. Module A2: Internal control of production plus supervised control of instruments at random intervals.

1. The internal control of the production plus supervised control of the instruments at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, of this article and it guarantees and declares, under its sole responsibility, that the measuring instruments in queparrafo_2">5. Conformity marking and declaration of conformity.

5.1 The manufacturer shall affix the marking which may correspond to him on the basis of Annex III and, under urer shall draw up the declaration of conformity which may correspond, in accordance with the regulatory framework, for each instrument model and keep it, together with the technical documentation, at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market. That declaration of conformity shall identify the instrument which is the subject of the instrument.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of the declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

5. The manufacturer's obligations set out in point 4 above may be fulfilled by his authorised representative on his behalf and under his responsibility, provided that they are specified in his mandate.

Article 9. Module D: Compliance with the type based on quality assurance of the production process.

1. Conformity with the type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5 of this Regulation. (a) it ensures and declares, under its sole responsibility, that the measuring instruments in question are in conformity with the type described in the type-examination certificate and satisfy the requirements of this royal decree application.

2. Manufacturing.

The manufacturer shall manage an approved quality management system for the manufacture, inspection of the finished product and the test of the measuring instrument in question in accordance with point 3 and shall be subject to supervision in accordance with point 4, both points of this Article.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to the body of his choice, for the measuring instruments in question.

This 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) a written declaration specifying that the same application has not been submitted to another notified body or metrological control body,

(c) all relevant information according to the category of instrument concerned,

d) the documentation relating to the quality system,

e) the technical documentation of the approved model and a copy of the type examination certificate.

3.2 The quality system shall ensure that the measuring instruments are in conformity with the type described in the type-examination certificate and satisfy the requirements of this royal decree that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and records.

In particular, it will include an appropriate description of:

(a) the quality objectives, the organisation chart and the responsibilities and powers of the management staff as regards the quality of the product,

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

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

(d) quality records, such as inspection reports and data on tests and calibration, reports on the qualification of the staff concerned,

e) the means by which the achievement of the quality of the required measuring instruments and the effective functioning of the quality system are monitored.

3.3 The body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2 above.

You will assume compliance with those requirements of the quality system elements that meet the specifications that may correspond to the corresponding harmonised standard.

In addition to experience in quality management systems, the audit team shall have at least one member who has experience in the field and the technology of the measuring instrument in question, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The audit team shall review the technical documentation referred to in paragraph 3.1 (e) above to check whether the manufacturer is capable of identifying the relevant requirements of this royal decree and to carry out the necessary examinations in order to ensure that the measuring instrument meets those requirements.

The decision will be communicated to the manufacturer. This shall include the conclusions of the audit and the reasoned decision of the assessment.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

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

The body will assess the proposed modifications and decide whether the modified quality system is still in line with the requirements set out in point 3.2 above or if a new assessment is necessary.

You will communicate your decision to the manufacturer. The notification shall include the findings of the examination and the reasoned decision of the assessment.

4. Surveillance under the responsibility of the body.

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

4.2 The manufacturer shall allow the entry of the body at the premises of manufacturing, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

a) the documentation relating to the quality system,

(b) quality records, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned.

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

4.4 Furthermore, the body may make unexpected visits to the manufacturer. In the course of such visits, the notified body or the metrological inspection body may carry out or carry out tests of the measuring instruments, if necessary, in order to check the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

The audit team shall review the technical documentation referred to in point 3.1 (e) of this Article to check whether the manufacturer is able to identify the relevant requirements of this royal decree and to carry out the necessary examinations in order to ensure that the measuring instrument meets those requirn particular:

a) the documentation relating to the quality system,

(b) the technical documentation referred to in point 2 above,

(c) quality records, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned and similar documents.

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

6.4 Furthermore, the body may make unexpected visits to the manufacturer. In the course of such visits, the body may, if deemed necessary, carry out tests on the instruments in order to check the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

7. Conformity marking and declaration of conformity.

7.1 The manufacturer shall bear the marking which may correspond to him on the basis of Annex III and, under the responsibility of the body referred to in point 5.1 above, the identification number of the latter to each measuring instrument that satisfies the applicable requirements of this royal decree.

7.2 The manufacturer shall draw up the declaration of conformity which may correspond to it, in accordance with the regulatory framework for each instrument model and shall keep it, together with the technical documentation, at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market. That declaration of conformity shall identify the measuring instrument which is the subject of the instrument.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of this declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

8. For a period of 10 years after the instrument has been placed on the market, the manufacturer shall have at the disposal of the national authorities:

(a) the documentation referred to in point 5.1 of this Article,

(b) the information relating to the modification referred to in point 5.5 of this Article that has been approved,

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

9. Each body shall inform its authority which has designated it on the approvals of quality systems issued or withdrawn, and shall, on a regular basis or upon request, make available to it the list of quality system approvals it has rejected, suspended or otherwise restricted.

10. The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 of this Article may be fulfilled, on his behalf and under his responsibility, by his authorised representative, provided that they are specified in his mandate.

Article 11. Module E: Compliance with the type based on the quality assurance of the instrument.

1. Conformity with the type based on the quality assurance of the instrument is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2 and 5 of this Regulation. (a) it ensures and declares, under its sole responsibility, that the measuring instruments in question are in conformity with the model described in the type-examination certificate and satisfy the requirements of this royal decree application.

2. Manufacturing.

The manufacturer shall manage an approved quality management system for the inspection of the finished instruments and the test of the measuring instruments in question in accordance with point 3, and shall be subject to monitoring as set out in point 4 both points of this article.

3. Quality system.

3.1 The manufacturer shall, for the measuring instruments in question, submit an application for the assessment of his quality management system to a body of his choice.

This 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) a written declaration specifying that the same application has not been filed with another body,

c) all relevant information for the intended instrument category,

d) the documentation relating to the quality system,

e) the technical documentation of the approved model and a copy of the type examination certificate.

3.2 The quality management system shall ensure the conformity of the instruments with the model described in the type examination certificate and with the requirements of this royal decree that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. This quality management system documentation will allow for a consistent interpretation of quality management programs, plans, manuals and records.

In particular, it will include an appropriate description of:

(a) the quality objectives, the organisation chart and the responsibilities and powers of the management staff as regards the quality of the measuring instruments,

(b) the examinations and tests to be carried out after manufacture,

(c) quality records, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned,

d) the means by which the effective operation of the quality system is monitored.

3.3 The body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2 above.

You will be given the compliance with those requirements of the quality system elements that meet the corresponding specifications of the corresponding harmonised standard.

In addition to experience in quality management systems, the audit team shall have at least one member with an evaluation exty system as approved and to maintain it in a manner that continues to be appropriate and effective.

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

The body will assess the proposed modifications and decide whether the modified quality system is still in line with the requirements set out in point 5.2 above or if a new assessment is necessary.

You will communicate your decision to the manufacturer. The notificatid out after manufacture,

(c) quality records, such as inspection reports and data on tests and calibration, reports on the qualification of the staff concerned,

d) the means by which the effective operation of the quality system is monitored.

5.3 The body shall evaluate the quality system to determine whether it meets the requirements referred to in point 5.2.

You will be given the compliance with those requirements of the quality system elements that meet the corresponding specifications of the corresponding harmonised standard.

In addition to experience in quality management systems, the team of auditors shall have at least one member who has experience in the field and the technology of the instrument concerned, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The audit team shall review the technical documentation referred to in point 2 above to check whether the manufacturer is able to identify the relevant requirements of this royal decree and to carry out the necessary examinations. to ensure that the instrument complies with those requirements.

The decision will be communicated to the manufacturer. This shall include the conclusions of the audit and the reasoned decision of the assessment.

5.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

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

The body will assess the proposed modifications and decide whether the modified quality system is still in line with the requirements referred to in point 5.2 above or if a new assessment is necessary.

You will communicate your decision to the manufacturer. This shall include the findings of the examination and the reasoned decision of the assessment.

6. Surveillance under the responsibility of the body.

6.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

6.2 The manufacturer shall allow the entry of the body at the premises of manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

a) the documentation relating to the quality system,

(b) the technical documentation referred to in point 2 above,

(c) quality records, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned.

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

6.4 Furthermore, the body may make unexpected visits to the manufacturer. During such visits the body may, if necessary, carry out, or carry out, tests on the instruments to check the proper functioning of the quality management system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

7. Conformity marking and declaration and national conformity marking.

7.1 The manufacturer shall affix the marking which may correspond to him on the basis of Annex III and, under the responsibility of the body referred to in point 5.1 above, the identification number of the latter to each measuring instrument that satisfies the applicable requirements of this royal decree.

7.2 The manufacturer shall draw up the declaration of conformity which may correspond to it, in accordance with the regulatory framework for each instrument model and shall keep it, together with the technical documentation, at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market. That declaration of conformity shall identify the instrument which is the subject of the instrument.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of this declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

8. The manufacturer, for 10 years after the instrument has been placed on the market, shall keep at the disposal of the national authorities:

(a) the documentation referred to in point 5.1 above,

(b) the information relating to the modification referred to in point 5.5 above that has been approved,

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

9. Each body shall inform the authority which designated it on the approvals of quality systems, issued or withdrawn, and shall, on a regular basis or upon request, make available to that authority the list of quality system approvals which rejected, suspended, or otherwise restricted.

10. The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 above may be fulfilled by his authorised representative on his behalf and under his responsibility, provided that they are specified in his mandate.

Article 13. Module F: Compliance with type based on product verification.

1. Conformity with the type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 5.1 and 6 below and ensures and declares, under its sole responsibility, that the measuring instruments in question, which comply with the provisions of the following point 3, are in conformity with the type described in the type-examination certificate and satisfy the requirements of this certificate; royal decree to apply to them.

2. The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the measuring instruments manufactured with the approved type described in the type examination certificate and with the requirements of this royal decree to apply to them.

3. Verification.

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 type described in the type examination certificate and with the requirements relevant to this royal decree to be applicable to you.

Tests and tests to verify the conformity of measuring instruments with the relevant requirements shall be carried out, at the choice of the manufacturer, either by exn carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and records.

In particular, it will include an appropriate description of:

(a) the quality objectives, the organisation chart and the responsibilities and powers of the management staff as regards the quality of the product,

(b) the examinations and tests to be carriee applicable requirements. In the absence of such harmonised standards, or normative document, the body concerned shall decide on the appropriate tests to be carried out.

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

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market.

6. Statistical verification of compliance.

6.1 The manufacturer shall take all necessary steps to ensure that the manufacturing process ensures the homogeneity of each batch manufactured and must submit the measuring instruments in homogeneous batches for verification.

6.2 A sample of each batch shall be taken at random in accordance with paragraph 6.4.

6.3 All measuring instruments in the sample shall be individually examined and subjected to appropriate tests as laid down in the harmonised standards, and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, to check their compliance with the applicable requirements of this royal decree, and to determine whether the batch is accepted or rejected. In the absence of such harmonised standards, or regulatory document, the notified body concerned shall decide on the appropriate tests to be carried out.

6.4 The statistical procedure must meet the following requirements:

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

(a) a quality level corresponding 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%.

6.5 If a lot is accepted, all measuring instruments of the batch shall be considered to be approved, with the exception of those measuring instruments of the sample which have not satisfactorily completed the tests.

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

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market.

If a lot is rejected, the body will take the necessary steps to prevent the introduction of that lot into the market. In the event of frequent rejection of lots, the body may suspend the statistical verification and take appropriate action.

7. Conformity marking and declaration of conformity.

7.1 The manufacturer shall apply the marking which may correspond to him on the basis of Annex III and, under the responsibility of the notified body referred to in point 4 above, the identification number of the latter. to each measuring instrument that satisfies the applicable requirements of this royal decree.

7.2 The manufacturer shall draw up the declaration of conformity which may correspond to it, in accordance with the regulatory framework for each instrument model and shall keep it, together with the technical documentation, at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market. That declaration of conformity shall identify the instrument which is the subject of the instrument.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of the declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of measuring instruments are provided to a single user, it may be interpreted that this requirement applies to a whole consignment or consignment and not to each separate instrument.

If agreed by the body referred to in point 5 above and under its responsibility, the manufacturer may also affix the identification number of that body to the measuring instruments.

8. If the body so agrees and under its responsibility, the manufacturer may apply the body's identification number to the measuring instruments during the manufacturing process.

9. Authorized representative.

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate. The authorised representative may not fulfil the obligations of the manufacturer referred to in points 2, first paragraph, 3 and 6.1 above.

Article 15. Module G: Compliance based on unit verification.

1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 5 below, and ensures and declares under his/her exclusive the liability of the measuring instrument in question, which complies with the provisions of point 4, is in accordance with the requirements of this royal decree which apply to it.

2. Technical documentation.

The manufacturer shall draw up the technical documentation in accordance with Article 13 and make it available to the body referred to in point 4. The documentation shall allow the assessment of the instrument's compliance with the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for a period of 10 years after the instrument has been placed on the market.

3. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured instrument with the applicable requirements of this royal decree.

4. Verification.

A body chosen by the manufacturer shall carry out appropriate examinations and tests, as provided for in the harmonised standards and/or regulatory documents, or equivalent tests established in other Member States, or shall carry out appropriate tests and tests. relevant technical specifications, to check the conformity of the instrument with the applicable requirements of this royal decree. In the absence of such harmonised standards, or normative 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 affix its identification number to the approved instrument, or make it placed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market.

5. Conformity marking and declaration of conformity.

5.1 The manufacturer shall apply to each measuring instrument the marking which may correspond to it on the basis of Annex III and, under the responsibility of the body referred to in point 4 above, the num to the manufacturer's premises.

The decision shall be communicated to the manufacturer or his authorised representative. This shall include the conclusions of the audit and the reasoned decision of the assessment.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

3.5 The manufacturer shall keep the body that has approved the quality system informed of any plaConformity marking and declaration of conformity.

5.1 The manufacturer shall apply to each measuring instrument the marking which may correspond to it on the basis of Annex III and, under the responsibility of the body referred to in point 3.1 above, the number of identification of the latter to each instrument that satisfies the requirements of this royal decree that apply to it.

5.2 The manufacturer shall draw up the declaration of conformity which may correspond to it, in accordance with the regulatory framework for each instrument model and keep it at the disposal of the national authorities during a period of ten years after the instrument has been placed on the market. The declaration of conformity shall identify the model instrument for which it has been drawn up.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of the declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

6. For a period of 10 years after the instrument has been placed on the market, the manufacturer shall have at the disposal of the national authorities:

(a) the technical documentation referred to in point 3.1 above,

(b) the documentation relating to the updates of the quality system referred to in point 3.1 above,

(c) the information relating to the modification referred to in point 3.5 above that has been approved,

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

7. Each body shall inform the authority that designated it on approvals of quality systems issued, or withdrawn, and shall, on a regular basis or upon request, make available to its competent authority the list of system approvals for quality that you have rejected, suspended, or otherwise restricted.

8. Authorized representative.

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 above may be fulfilled, on his behalf and under his responsibility, by his authorised representative as long as they are specified in his mandate.

Article 17. Module H1: Conformity based on full quality assurance plus design examination.

1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2 and 6 below and ensures and declares, under his or her exclusive responsibility, which the measuring instruments in question satisfy the requirements of this royal decree that apply to it.

2. Manufacturing.

The manufacturer shall manage an approved quality system for design and manufacture, as well as for the inspection of the finished instruments and the testing of the measuring instruments in question, as specified in the Point 3 below, and shall be subject to the surveillance referred to in point 5.

The adequacy of the technical design of the measuring instrument shall have been examined in accordance with the provisions of paragraph 4 below.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to the body for the measuring instruments in question.

This 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) all relevant information according to the category of instrument concerned,

c) the documentation relating to the quality system,

(d) a written declaration specifying that the same application has not been filed with another body.

3.2 The quality system will ensure the conformity of measuring instruments with the requirements of this royal decree that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and records.

In particular, it will include an appropriate description of:

(a) the quality objectives, the organisation chart and the responsibilities and powers of the management staff as regards the design and quality of the instruments,

(b) the technical design specifications, including the rules to be applied as well as, where relevant harmonised standards and/or regulatory documents are not to be fully implemented, as well as the means with which they are ensure compliance with the essential safety requirements of this royal decree, by applying other relevant technical specifications,

(c) design verification and verification techniques, processes and systematic measures to be used when designing measuring instruments as regards the category of instruments in question,

d) the corresponding techniques, processes and systematic actions of manufacturing, quality control and quality assurance to be used,

e) the tests and tests to be carried out before, during and after manufacture and their frequency,

(f) quality records, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned,

g) the means by which the achievement of the design and the quality of the required product is followed, as well as the effective functioning of the quality system.

3.3 The body shall evaluate the quality system to determine whether it meets the requirements referred to in point 3.2. It shall, for alleged compliance with those requirements of the elements of the quality system, comply with the relevant specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the audit team will have at least one experienced member as an evaluator in the field and technology of the instrument in question, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visite it with all the necessary information, in particular:

a) the documentation relating to the quality system,

(b) the quality records provided for in the part of the quality system dedicated to the design, such as analysis results, calculations, tests,

(c) the quality records provided for in the part of the quality system dedicated to manufacturing, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned.

4.3 The body shorised during the amplitude modulation test of the radiated electromagnetic field must not exceed the maximum allowed error.

3. The manufacturer shall specify the climatic, mechanical and electromagnetic environments for which the measuring 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 regulation.

2. Climate environments:

The manufacturer shall specify the upper teriodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

5.4 Furthermore, the body may make unexpected visits to the manufacturer. In the course of such visits, the body may, if necessary, carry out or carry out tests of the instruments in order to check the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

6. Conformity marking and declaration of conformity.

6.1 The manufacturer shall affix the marking which may correspond to him on the basis of Annex III and, under the responsibility of the body referred to in point 3.1 above, the identification number of the latter to each instrument that satisfies the requirements of this royal decree that apply to it.

6.2 The manufacturer shall draw up the declaration of conformity which may correspond to it, in accordance with the regulatory framework for each instrument model and keep it at the disposal of the national authorities during a period of ten years after the instrument has been placed on the market. The declaration of conformity shall identify the model which is the subject of the declaration and the number of the design examination certificate.

A copy of the declaration of compliance shall be provided to the competent authorities upon request.

A copy of the declaration shall be provided in accordance with each measuring instrument that is placed on the market. However, in cases where a large number of instruments are supplied to a single user, it may be interpreted as applying to a whole consignment or consignment and not to each separate instrument.

7. For a period of 10 years after the instrument has been placed on the market, the manufacturer shall have at the disposal of the national authorities:

(a) the documentation relating to the updates of the quality system referred to in point 3.1 above,

(b) the information relating to the adaptation referred to in point 3.5 above that has been approved,

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

8. Authorized representative.

The manufacturer's authorised representative may submit the application referred to in points 4.1 and 4.2 above and fulfil the obligations referred to in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under their liability, provided they are specified in their command.

ANNEX II

Common essential requirements for measuring instruments subject to State metrological control

The measuring instruments must provide a high level of metrological protection so that 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.

Article 1. Scope of application.

This annex applies to all measuring instruments submitted to the State's metrological control unless otherwise specified in its specific regulation.

This section sets out the essential requirements to be met by the measuring instruments, supplemented, in cases where they so require, by the specific requirements laid down, where appropriate, in the regulations specific requirements, in which certain aspects of the general requirements are detailed.

Article 2. Definitions.

a) Measuring: Particular magnitude subjected to measurement.

b) Magnitude Of Influence: Magnitude that is not the measurement but has an effect on the outcome of the measurement.

c) 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.

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

e) Critical variation value: Critical variation value is that value to which the change in the measurement result is considered undesirable.

f) 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 given magnitude.

g) Direct Selling Transaction Transaction: A commercial transaction is direct-selling if the following three conditions are met:

a) the measurement result serves as the basis for the amount to be paid,

b) 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,

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

h) Climate environments: Climate environments mean the conditions under which measuring instruments can be used. In order to respond to the climate differences between Member States, a range of temperature limits has been defined.

i) Public service company: A utility is considered as a public service provider of electricity, gas, thermal energy or water.

Article 3. Essential requirements.

1. Errors allowed:

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

Unless otherwise specified in the specific requirements for the measuring instrument, the maximum permissible error shall be expressed as the bilateral value of the deviation of the true measurement value.

2. In nominal operating conditions and in the presence of a disturbance, the operating requirements shall be those set out in the relevant requirements relating to the specific measuring instrument.

When the measuring instrument is designed to be used in an established permanent continuous electromagnetic field, the operation autthe technical documentation for a period of 10 years after the introduction of the instrument into the market.

5. Surveillance under the responsibility of the body.

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

5.2 The manufacturer shall allow the entry of the body at the premises of design, manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the measurement result, unless the presence of such defects is obvious.

Article 10. Fitness.

1. A measuring instrument shall be without any characteristic which may favour its fraudulent use. The possibility of inadvertent improper use should also be minimised.

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

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

4. Where a measuring instrument is designed for measurement of measurement values that remain constant over time, the measuring instrument shall be insensitive to small fluctuations in the value of the measurement, or shall act in consequence.

5. A measuring instrument shall be resistant and shall be made from materials appropriate to the conditions for which it has been designed.

6. The measuring instrument shall be designed in such a way as to enable the measurement activities to be monitored once the instrument has been placed on the market and started to be used. If necessary, as part of the instrument the equipment or software to be checked shall be included. The test procedure shall be described in the operating manual.

When a measuring instrument is associated with software containing other functions in addition to the measurement function, the software indispensable for the metrological characteristics shall be identifiable and shall not be influenced further. of the allowable by the associated software.

Article 11. Protection against corruption.

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 to the device. distance to the measuring instrument.

2. Any component of the physical support that is critical to the metrological characteristics shall be designed so that it can be protected. The planned safety measures should include evidence of any intervention.

3. Any software 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.

An obvious evidence of intervention should be available over a reasonable period of time.

4. The measurement data, the software that is critical to the characteristics of the measurements and the parameters of metrological importance stored or transmitted, shall be adequately protected against accidental corruption.

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 or partial reference for the payment cannot be set to zero during use.

Article 12. Information to be included in the instrument and accompany it.

1. The following data shall be included in a measuring instrument:

a) name, registered trade name or trademark of the manufacturer,

b) information about their accuracy,

and, where applicable,

c) required data about the conditions of use,

d) measuring capacity,

e) measure field,

f) marked identity,

g) number of the type examination certificate or design exam certificate,

h) information on whether other additional devices, which provide metrological results, meet or not comply with the provisions of this royal decree on legal metrological control.

2. Instruments which 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 of this royal decree.

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:

a) the nominal operating conditions,

b) the mechanical and electromagnetic environment classes,

c) the upper and lower temperature limit, and, if condensation is or not possible, open or closed site,

d) the instructions for installation, maintenance, repairs, and allowable adjustments,

e) instructions for proper handling and special operating conditions,

f) the compatibility conditions with interfaces, subsets, or measurement instruments.

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

5. Unless otherwise stated in the specific regulation applicable to the measuring instrument or system, the scale range for a measured value shall be in the form of 1 × 10ⁿ, 2 × 10ⁿ or 5 × 10ⁿ, where n an integer or zero. The unit of measure or its symbol must appear next to the numeric value.

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

7. The units of measurement used and their symbols shall be in conformity with the provisions of Union legislation relating to units of measurement and their symbols.

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

Article 13. Indication of the result.

1. The indication of the result shall be carried out by means of a visual presentation or printed document.

2. The indication of any result shall 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.

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

4. The measuring instruments for commercial direct sales transactions shall be designed in such a way as to present the result of the measurement to both parties of 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 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.

Article 9. Reliability.

A measuring instrument shall be designed to reduce as much as possible defects that may result in an inaccuratthe consumer by an auxiliary device which does not comply with the relevant requirements of this royal decree shall contain the restrictive information. appropriate.

5. Irrespective of whether or not they can be read at a distance, measuring instruments intended for the measurement of public services must be provided in all cases with a controlled metrologically accessible indicator without tools for the measurement. consumer. The reading of this indicator will be the measurement result that will serve as a basis for the amount to be paid. that identify the Public Administration that performs the registration, in accordance with the identification code list contained in Table 1.

b) "Y" is the letter that serves to identify the activity sector, according to the related identification codes in Table 2.

c) "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 registration.

d) "MM" are the two digits corresponding to the istics, 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.

2. 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 detachment. It shall have a rectangular shape and its dimensions shall be suitable for the instrument concerned and its visibility.

Section 3. Metrological Control Registry Subscriptions

Article 6. Identifications.

1. For the purposes of the identification of the inscriptions of the Register of Metrological Control set out in Article 18 of Law 32/2014 of 22 December of Metrology, the following code tables are indicated:

Table 1. Identification codes for public administrations

07

11

Autonomous Community of Extremadura

15

Administration	Code
Spanish Metrology Center	00
Country Autonomous Community
Autonomous Community
Community of Galicia	03
04
04	04	05
Cantabria Autonomous Community	06
07
	08
Community	08	08	08 Centro_table_body "> 09
Aragon Autonomous Community
11
11
12
Community Foral Community	12
12	12
15
15
Community of Castilla and Lion	Community of Castile and Lion	Centro_table_body "> 17

Table 2. Activity Sectors Identification Code

	M	Mass, strength, and weigh.
E
G	Gases.
Gases.
A	Water.
H	Hydrocarbons.
P	Pressure.
	Dimensional.
V		C
C	C	Calorimetry.
T	Time and frequency.
N	Prepackaged.
I	Special instruments.

2. Any registration in the Register of Metrological Control among those provided for in Article 46.1 of this royal decree, shall be assigned an alpha-numeric identification, in the following form:

Where:

a) "XX" represent the two digitsground of at least 25 mm and the whole shall be crossed by two diagonals.

2. The instruments referred to in Article 12.1 of this royal decree shall incorporate a label, with the characteristics of the indelibility set out in this Annex, by establishing restrictive use for the same with the following caption on white background:

3. The instruments referred to in paragraph 7.8 of Appendix I ed or the manufacturer shall provide the means to facilitate such assessment. The software shall be designed in such a way that it does not support disturbances, other software or other interfaces or sub-assemblies. If the software used to show or print the legally relevant stored data is not integrated into the instrument, it will also be subjected to state metrological control. It shall be ensured that the security and stability of the instruments using an operating system is in accordance with the provisions set out in this Annex for the legally relevant softwa one of the seals of the instrument by another with better systems of detection of its violation. In order to allow this to be authorised, the instrument must have at least two seals which prevent its opening in such a way as to allow the replacement of only one of them.

ANNEX IV

Legally relevant software linked to measurement in measuring instruments subjected to State metrological control

Article 1. Object and scope of application.

1. The purpose of this Annex is to regulate the legally relevant software of measuring instruments (or sub-assemblies thereof) during the conformity assessment process, ensuring compliance with the essential requirements common to the measuring instruments, as well as, where appropriate, the specific requirements. Conformity assessment requires an analysis of the characteristics of this software and, where applicable, of the equipment on which it works.

2. This Annex applies to all measuring instruments subject to the metrological control which are available to the software.

Article 2. Terms and definitions.

Software Update: A process by which the software is automatically transferred to a measuring instrument or subset thereof, by any technical means, from a local or remote source (p. e.g., interchangeable storage media, laptop computer, remote computer), through connections established discretionally by the manufacturer (p. e.g., direct link, networks). The instrument will have a non-volatile event record where the features of the software update events will be stored. The capacity of such registration shall be appropriate for each type of instrument and shall allow for its history of updates. In case of filling of the register, the instrument shall be disabled for the performance of legally relevant metrological functions.

Long-term storage: recording the data resulting from the measurements that are legally relevant. It shall be incorporated in the instrument itself or system where it is regulated and independently of its classification of type (P or U).

IT Configuration (Information Technology): Design of a measuring instrument with respect to the IT functions and characteristic elements that are independent of the measurement function. They will have consideration of IT configurations for the purposes of the application of this annex: the long-term storage of the measurement data, the transmission of the measurement data, the updating of the software and the separation of software.

Software identifier: sequence of readable characters, unfailingly bound to software (usually version number).

Specifically developed measurement instrument (type P): a measuring instrument designed and built specifically for a particular task. Therefore, all software is developed to perform the measurement.

Instrument of measurement using a universal computer (type U): measuring instrument consisting of a general purpose computer, which is usually a personal computer-based system, to perform functions legally relevant. A measurement system is assumed to be of type U if the conditions of a specifically developed measuring instrument (type P) are not met.

Communication interface: electronic, optical, radio-frequency interface or by any other system or type that allows the information to be automatically transferred between the components of the measuring instruments, subsets and external devices.

User interface: an interface that constitutes the part of the instrument or measurement system that allows information to be transmitted between a user and the measuring instrument or its components, such as a switch, a keyboard, or a mouse.

Device-specific parameter: legally relevant parameter with a value that depends on each instrument. Device-specific parameters are composed of tuning parameters and configuration parameters (p. e.g., maximum value, minimum value, units of measure, serial number, and other similar concepts.

Type specific parameter: legally relevant parameter whose value is the same in all instruments of that type, among others for example: SW version, checksum, model. The specific parameters of the type are part of the software.

Legally relevant parameter: parameter of a measuring instrument or of a subset subjected to metrological control. The following legally relevant parameters can be distinguished: specific parameters of the specific type and parameters of the device.

Software protection: a method to ensure the integrity of the legally relevant software of the measuring instrument, by means of physical or logical seals.

Event Log: A record that allows data for software updates or parameter change to be preserved. Serves as a means to monitor these.

Error Log: A continuous data file that contains information about the faults and defects that influence the legally relevant features.

Separation of software: Unclear separation of software between the legally relevant and the non-relevant. The exchange of data between both types of software must be done through a protective interface. This interface is part of the legally relevant software. If there is no software separation, all software as a whole is considered legally relevant.

Legally relevant software: computer programs, data, records, and parameters pertaining to a measurement or subset instrument, which define or satisfy functions that are subject to metrological control. These functions are those that contribute to the calculation of or affect the measurement values or that contribute to auxiliary functions, such as:

a) visualization, storage, and security of legally relevant data and records,

b) Software identification,

c) software update,

d) metrologically relevant data transmission, reception and verification,

e) printing of legally relevant data.

Validation: confirmation of compliance with the particular requirements for the intended use by examination and the provision of objective evidence.

Article 3. Generalities.

1. In instruments which are subject to State metrological control, the presentation of a measurement result shall be clear and unambiguous and shall be generated by software subject to metrological control.

2. The software of the measuring instrument shall be designed in such a way as to enable the conformity assessment to be easily assessnstruments having established useful life if an intervention occurs in the instrument.

Article 10. Scope of territoriality in the use of seals in repairs and modifications of instruments in service.

The seals whose issuance has been legally effected under a national territory law may be used anywhere in the national territory, as provided for in Article 19.3 of Law 32/2014, of 22 of December, of Metrology. To this end, the Public Administrations concerned, within the Commission of Legal Metrology of the Higher Councheavy and accessible to the two interested parties to the measure. However, in the instruments used for direct sale to the public, the devices that are heavy for the seller and the customer must meet the essential requirements.

Design and Build

1. General requirements.

1.1 The design and manufacture of the instruments will have to be carried out in such a way that the instruments retain their metrological qualities if they are used and installed properly and if they work in the mediu">ANNEX V

Compliance Statement Model

EU or national declaration of conformity [manufacturer's optional number]

1. Instrument/instrument model (product, type, batch or serial number):

2. Name and address of the manufacturer and, where applicable, his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Purpose of the declaration (identification of the instrument permitting traceability) may, where necessary for the identification of the instrument, include an image):

(a) (Case of instrument subject to harmonised legislation). The purpose of the statement described above is in accordance with the relevant Union harmonisation legislation (quote the relevant provisions). Or

b) (Case of instrument subject to non-harmonised legislation). The purpose of the statement described above is in accordance with Spanish legislation: (to quote the relevant provisions).

5. References to the relevant harmonised standards or normative documents used, or references to the other technical specifications for which conformity is declared.

6. Where appropriate, it shall be cited:

(a) the notified body or metrological control (name, identification number),

b) has performed ... (description of the intervention), and

c) issues certificate n. º:

7. Additional information:

Signed on behalf of:

(place and date of issue):

(name, charge) (signature):

ANNEX VI

Non-automatic weighing instruments

Article 1. Object and scope of application.

1. The purpose of this Annex is to regulate the metrological control of the State of the non-automatic weighing instruments as defined in Article 2.

2. This Annex shall apply to all non-automatic weighing instruments distinguishing, as far as their use is concerned, the following fields:

a) determination of the mass for commercial transactions,

(b) determination of the mass for the calculation of a fee, tariff, tax, premium, fine, remuneration, compensation or other similar type of fee,

c) determination of the mass for the application of laws or regulations or for judicial expertise,

d) determination of the mass in the practice of medicine as regards the heavy of the patients for reasons of control, diagnosis and medical treatments,

(e) determination of the mass for the preparation of medicinal products in pharmacy and the determination of the mass in the manufacture and analysis carried out in the pharmaceutical laboratories,

f) determination of the price based on the mass for direct sale to the public and the preparation of prepackaged,

g) any application other than those mentioned in (a) to (f).

Article 2. Definitions.

weighing instrument: a measuring instrument that can be used to determine the mass of a body using the action of gravity on the body. A weighing instrument may also be used to determine other quantities, quantities, parameters or mass-related characteristics.

Non-automatic weighing instrument or instrument: weighing instrument requiring the intervention of an operator to determine the weight.

Article 3. Metrological control phases.

The metrological control of the State established in this Annex is the one that is regulated in Section 3 of Chapter III of this royal decree and which refers to the phase of marketing and putting into service.

Article 4. Essential requirements.

1. The essential requirements to be met by the non-automatic weighing instruments intended to be used for applications (a) to (f) of Article 1 shall be those set out in Appendix I.

2. The tests to be carried out for conformity assessment shall be as set out in Appendix II.

3. The entries to be included in the non-automatic weighing instruments are set out in Appendix III.

4. The conformity assessment procedures for non-automatic weighing instruments intended for use in applications (a) to (f) of Article 1 shall be those described in Appendix IV.

Article 5. Procedures for the assessment of conformity.

1. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1, fields of use (a) to (f) of this Annex shall be chosen, including those described in Appendix IV by the Commission. manufacturer, selecting any of the following options:

a) Module B, EU type examination, plus Module D, conformity to type based on quality assurance of the production process.

b) Module B, EU type examination, plus Module F, compliance with type based on instrument verification.

c) Module G, compliance based on unit verification.

2. In addition, for the instruments referred to in Article 1 for the fields of use (a) to (f) of this Annex, which do not use electronic devices and whose load measurement device does not use springs to balance the load, you can select the following options:

a) Module D1, quality assurance of the production process.

b) Module F1, compliance based on instrument verification.

APPENDIX I

Essential Requirements

The terminology used is that of the International Organization for Legal Metrology.

If the instrument comprises or is connected to devices that are not used or are not intended to be used for the applications referred to in points (a) to (f) of Article 1, those devices shall not be subject to such devices. essential requirements.

If the instrument comprises or is connected to more than one indicator or printer device used for the applications referred to in Article 1 (a) to (f) of this Annex, those that repeat the results of the heavy duty and which cannot influence the proper functioning of the instrument shall not be subject to the essential requirements if a part of the instrument satisfying the essential requirements accurately and indelibly prints or records the results of the instrument the etrological control, indicating " What should be used together with this certificate of conformity " This information shall be at least the following:

a) Identification and description of the electronic components that are important to the software.

b) Overview of the computer environment required to use the software under metrological control.

c) General description of the software subjected to metrological control (including software separation, if it has been implemented).

TABLE 3

Maximum errors allowed

				Maximum Allowed
Class I	Class II	a_centro">5 g ≤ e	20 e		500	10 000
IIII	5 g ≤ e	10 e	100	1 000

For classes II and III instruments that serve to determine a transport rate, the minimum range is reduced to 5 e.

2.2 Scale intervals.

2.2.1 The actual scale interval (d) and the verification scale interval (e) must correspond to:

1 × 10^k, 2 × 10^k, or 5 × 10^k units of mass,

being:

k = an integer or zero.

2.2.2 For all instruments without auxiliary indicator devices:

d = e

2.2.3 For all instruments with auxiliary indicator devices, the following conditions apply:

e = 1 × 10^k g

d < e ≤ 10 d

These conditions do not apply for class I instruments with d < 10^-4 g, in which e = 10^-3 g.

3. Classification.

3.1 Instruments with a single weighing field.

Instruments with auxiliary indicator devices shall correspond to classes I or II. The lower limit of the minimum range of the instruments of these two classes is obtained from Table 1, replacing the verification scale interval (e) of the third column by the actual scale interval (d).

When d < 10^-4 g, the maximum scope of class I may be less than 50 000 e.

3.2 Instruments with multiple weighing fields.

Multiple weighing fields are permitted with such that they are clearly indicated in the instrument. Each weighing field shall be classified according to paragraph 3.1. If the weighing fields correspond to different classes of accuracy, the instrument shall meet the most stringent requirements applying to the classes of accuracy to which the weighing fields correspond.

3.3 Multirange Instruments.

3.3.1 Instruments with a weighing range may have several partial weighing fields (multi-range instruments).

Multi-range instruments must not carry an auxiliary indicator device.

3.3.2 Each partial weighing field i of the multi-range instruments is defined by:

-its verification scale interval and_i, with e_{(i + 1)} > and_i

-its Max_i max reach with Max_r = Max

-your Min_i minimum scope with Min_i = Max_{(i -1)} and Min₁ = Min

being:

i = 1, 2, ... r,

i = number of weighing partial fields,

r = total number of weighing partial fields.

All scopes are understood as referring to net load, regardless of the value of the tare used.

3.3.3 The partial weighing fields are classified according to Table 2. All of them must correspond to the same kind of accuracy, that is, the kind of accuracy to which the instrument belongs.

TABLE 2

Multirange Instruments

i = 1, 2, ... r

i = number of weighing partial fields

r = total number of weighing partial fields

	Verification scale interval (e)	Minimum Scope (Min)	Number of verification scale
		minimum value	minimum value (1) n = Maxi /ei + 1	maximum value n = Maxi /ei
	I	0.001 g ≤ ei	100 and1	50 000	-
II	0.001 g ≤ ei ≤ 0.05 g	20 and1	5 000	100 000
0.1 g ≤ ei	50 and1	5 000	100
III	0.1 g ≤ ei	20 and 1	500	10 000
IIII	5 g ≤ ei	10 and1	50	1 000

⁽¹⁾ When i = r, the corresponding column in Table 1 will be used, replacing and by and_r.

4. Accuracy.

4.1 In the application of the conformity assessment procedures in Appendix 4, the error of indication shall not exceed the maximum permissible error indicated in Table 3. If this is a digital indication, the indication error will be corrected for the rounding error.

The maximum allowable errors will be applied to the net value and the tare value for all possible loads, with the exception of thed>

0.001 g ≤ e

100 e

50 000

-

II

0,001 g ≤ e ≤ 0,05 g

20 e

100

100 000

1.2 The EU type examination may be carried out in any of the following ways:

(a) the examination of a representative sample of the intended production of the complete instrument (type of production),

(b) the assessment of the adequacy of the technical design of the instrument by examination of the technical documentation and supporting documentation referred to in point 1.3, plus the examination of the representative samples of the the intended production of one or more essential parts of the instrument (combination of the type of production and the type of design),

(c) the assessment of the adequacy of the technical design of the instrument by examining the technical documentation and supporting documentation referred to in point 1.3, without examining a sample (design type).

1.3 The manufacturer shall submit an EU-type examination application to a single notified body of his choice.

This 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) A written declaration specifying that the same application has not been filed with another notified body.

c) The technical documentation. The technical documentation shall permit the assessment of the conformity of the instrument with the applicable requirements of this royal decree and shall include an appropriate risk assessment and assessment. It shall also specify the applicable requirements and establish, to the extent that it is relevant for the assessment, design, manufacture and operation of the instrument. It shall also include, where appropriate, at least the following elements:

i) a general description of the instrument,

ii) the design and manufacturing plans, and the schemas of the components, subassemblies, circuits, etc.,

(iii) the descriptions and explanations necessary for the understanding of such plans and schemes and the functioning of the instrument,

(iv) a list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, the description of the solutions adopted to meet the essential requirements of this royal decree, including a list of other relevant technical specifications applied; in the case of harmonised standards which are partially applied, they shall be specified in the documentation technique the parts that have been applied,

v) the results of the design calculations performed, the examinations performed, etc.,

vi) the reports on the trials.

(d) The representative samples of the intended production; the notified body may request further samples if the test programme so requires.

e) The documentation supporting the adequacy of the technical design. This supporting documentation shall mention all the documents that have been used, in particular where the relevant harmonised standards have not been fully applied. The supporting documentation shall include, if necessary, the results of the tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer or by another test laboratory on its behalf and under your responsibility.

1.4 The notified body will be responsible for the following:

Regarding the instrument:

1.4.1 You will examine the technical documentation and supporting documentation to assess the adequacy of the technical design of the instrument.

About the sample or samples:

1.4.2 Comprove that they have been manufactured in accordance with the technical documentation and establish the elements that have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements that have been designed in accordance with other relevant technical specifications.

1.4.3 The appropriate examinations and tests shall be carried out or carried out to check whether, when the manufacturer has chosen to apply the solutions of the relevant harmonised standards, these solutions have been applied correctly.

1.4.4 The appropriate tests and tests shall be carried out or carried out to check whether, in the event that the solutions of the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer for apply other relevant technical specifications meet the relevant essential requirements of this royal decree.

1.4.5 Acordara with the manufacturer the place where the examinations and tests are to be carried out.

1.5 The notified body shall draw up an assessment report to take into account the activities carried out in accordance with point 1.4 and its results. Without prejudice to its obligations to the notifying authorities, the notified body shall only disclose the content of this report, in full or in part, with the agreement of the manufacturer.

1.6 If the type meets the requirements of this royal decree that apply to the instrument in question, the notified body shall issue the manufacturer with an EU-type examination certificate. This certificate shall include the name and address of the manufacturer, the conclusions of the examination, the conditions of validity (where applicable) and the data necessary to identify the approved type. One or more annexes may be attached to the EU-type examination certificate.

The EU type-examination certificate and its annexes shall contain all relevant information to assess the conformity of the instruments manufactured with the type examined and to enable the control in service.

The EU-type examination certificate shall be valid for 10 years from the date of issue and may be renewed for 10-year periods. In the event of fundamental changes in the design of the instrument, for example resulting from the application of new techniques, the validity of the EU-type examination certificate may be limited to two years and extended for a period of three years.

If the type does not satisfy the applicable requirements of this royal decree, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, explaining in detail its negative.

1.7 The notified body shall be kept informed of changes in the generally recognised state of the art which indicate that the approved type can no longer meet the applicable requirements of this royal decree, and shall determine whether or not the Such changes require further research. In that case, the notified body shall inform the manufacturer accord class="parrafo_2">In addition, manufacturers shall indicate in the instrument their name, registered trade name or registered trademark and their postal address. The address shall indicate a single place where the manufacturer can be contacted.

Such instruments shall not bear the conformity marking set out in this royal decree.

APPENDIX IV

Compliance assessment procedures

1. Module B: EU type examination

1.1 The EU-type examina quality documents, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned, etc.,

e) the means by which the achievement of the quality of the product required and the effective functioning of the quality system are monitored.

3.5.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in point 3.5.2

You will be given the compliance with those requirements of the quality system elements that meet the corresponding specifications of the corresponding harmonised standard.

In addition to experience in quality management systems, the team of auditors shall have at least one member who has experience in the field and the technology of the instrument concerned, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises. The team of auditors shall review the technical documentation referred to in point 3.2 to check whether the manufacturer isin point 2.3.1, the identification number of the last on each instrument conforming to the type described in the EU type-examination certificate and satisfies the applicable requirements of this royal decree.

2.5.2 The manufacturer shall draw up an EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for a period of 10 years after the instrument has been introduced into the instrument. market. The EU declaration of conformity shall identify the model of the instrument for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

2.6 For a period of 10 years after the instrument has been placed on the market, the manufacturer shall have at the disposal of the national authorities:

(a) the documentation referred to in point 2.3.1,

(b) the information relating to the adaptation referred to in point 2.3.5 which has been approved,

(c) the decisions and reports of the notified body referred to in points 2.3.5, 2.4.3 and 2.4.4.

2.7 Each notified body shall inform its notifying authority of the approvals of quality systems, issued or withdrawn, and shall, on a regular basis or upon request, make the list available to its notifying authority. of quality system approvals that you have rejected, suspended, or otherwise restricted.

2.8 Authorized Representative.

The manufacturer's obligations referred to in points 2.3.1, 2.3.5, 2.5 and 2.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

3. Module D1: Ensuring the quality of the production process

3.1 The quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 3.2, 3.4 and 3.7 and ensures and declares, under its sole responsibility, that the instruments in question satisfy the applicable requirements of this royal decree.

3.2 Technical documentation.

The manufacturer will produce the technical documentation. The documentation shall allow the assessment of the instrument's compliance with the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the instrument. The technical documentation shall include, where appropriate, at least the following elements:

a) A general description of the instrument.

b) The design and manufacturing plans, and the schemas of the components, subassemblies, circuits, etc.

(c) The descriptions and explanations necessary for the understanding of such plans and schemes and the functioning of the instrument.

(d) A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where such harmonised standards have not been applied, the description of the solutions adopted to meet the essential requirements of this royal decree, including a list of other relevant technical specifications applied. In the case of harmonised standards that are applied in part, the parts that have been applied shall be specified in the technical documentation.

e) The results of the design calculations performed, the examinations performed, etc.

f) The reports on the trials.

3.3 The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for a period of 10 years after the instrument has been placed on the market.

3.4 Manufacturing.

The manufacturer shall manage an approved quality system for production as well as for the inspection of the finished product and testing of the instruments as specified in point 3.5 and shall be subject to surveillance by the manufacturer. referred to in point 3.6.

3.5 Quality System.

3.5.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the instruments concerned.

This 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) a written declaration specifying that the same application has not been filed with another notified body,

(c) all relevant information according to the category of instrument concerned,

d) the documentation relating to the quality system,

e) the technical documentation referred to in point 3.2.

3.5.2 The quality system will ensure that the instruments meet the applicable requirements of this royal decree.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and documents.

In particular, it will include an appropriate description of:

(a) the quality objectives, the organisation chart and the responsibilities and powers of the management staff as regards the quality of the product,

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

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

(d)e examination and the reasoned assessment decision.

2.4 Surveillance under the responsibility of the notified body.

2.4.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

2.4.2 The manufacturer shall allow the notified body to enter the premises of manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

The technical documentation shall include, where appropriate, at least the following elements:

a) A general description of the instrument.

b) The design and manufacturing plans, and the schemas of the components, subassemblies, circuits, etc.

(c) The descriptions and explanations necessary for the understanding of such plans andg process.

4.7 Authorized Representative. The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate. The authorised representative may not fulfil the manufacturer's obligations referred to in point 4.2.

5. Module F1: Compliance based on instrument verification

5.1 Compliance based on the verification of the instruments is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 5.2, 5.3 and 5.6, and ensures and declares under its sole responsibility that the instrument in question, which complies with the provisions of point 5.4, is in accordance with the applicable requirements of this royal decree.

5.2 Technical documentation.

5.2.1 The manufacturer shall draw up the technical documentation. The documentation shall allow the assessment of the instrument's compliance with the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the instrument. The technical documentation shall include, where appropriate, at least the following elements:

a) A general description of the instrument.

b) The design and manufacturing plans, and the schemas of the components, subassemblies, circuits, etc.

(c) The descriptions and explanations necessary for the understanding of such plans and schemes and the functioning of the instrument.

(d) A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where such harmonised standards have not been applied, the description of the solutions adopted to meet the essential requirements of this royal decree, including a list of other relevant technical specifications applied. In the case of harmonised standards that are applied in part, the parts that have been applied shall be specified in the technical documentation.

e) The results of the design calculations performed, the examinations performed, etc.

f) Test reports.

5.2.2 The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for a period of 10 years after the instrument has been placed on the market.

5.3 Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the instruments manufactured with the applicable requirements.

5.4 Verification.

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to verify the conformity of the instrument with the applicable requirements of this royal decree. The examinations and tests to verify compliance with those requirements shall be carried out by examination and testing of each of the instruments as specified in point 5.5.

5.5 Verification of conformity by examination and testing of each instrument.

5.5.1 All instruments shall be individually examined and the appropriate tests shall be submitted to them, as provided for in the harmonised standards or equivalent tests laid down in other relevant technical specifications, to verify compliance with the applicable requirements. In the absence of such harmonised standards, the notified body concerned shall decide on the appropriate tests to be carried out.

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

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for a period of 10 years after the instrument has been placed on the market.

5.6 Conformity Marking and EU Declaration of Conformity.

5.6.1 The manufacturer shall affix the CE marking and the additional metrology marking set out in this royal decree and, under the sole responsibility of the notified body referred to in point 5.4, the identification number of the latter in each instrument that satisfies the applicable requirements of this royal decree.

5.6.2 The manufacturer shall draw up an EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for a period of 10 years after the instrument has been introduced into the instrument. market. The EU declaration of conformity shall identify the model of the instrument for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

If the notified body referred to in point 5.5 has so agreed, the manufacturer may also place, under the responsibility of the notified body, the latter's identification number on the instruments.

5.7 The manufacturer may, if agreed by the notified body and under the responsibility of the notified body, place the identification number of the notified body in the instruments during the manufacturing process.

5.8 Authorized Representative. The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate. The authorised representative may not fulfil the manufacturer's obligations referred to in paragraphs 5.2.1 and 5.3

6. Module G: Compliance based on unit verification

6.1 Compliance based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 6.2, 6.3 and 6.5 and ensures and declares under its sole responsibility that the instrument in question, which complies with the provisions of point 6.4, is in accordance with the applicable requirements of this royal decree.

6.2 Technical documentation.

6.2.1 The manufacturer shall draw up the technical documentation and make it available to the notified body referred to in point 6.4. The documentation shall allow the assessment of the instrument's compliance with the relevant requirements and shall include an appropriate risk assessment and assessment. It shall spe last on each instrument that is in conformity with the approved type described in the EU type-examination certificate and satisfies the applicable requirements of this royal decree.

4.5.2 The manufacturer shall draw up an EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for a period of 10 years after the instrument has been introduced into the instrument. market. The EU declaration of conformity shall identify the model of the instrument for which it has been drawn up.

Rail bridge: automatic weighing instrument equipped with a load receiver and which includes rails for the carriage of wagons.

Article 3. Metrological control phases.

The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and refers to the marketing and commissioning phase.

Article 4. Essential requirements.

1. The essential requirements to be met by the automatic weighing instruments shall be those set out in Appendix I.

2. The tests to be carried out for conformity assessment shall be as set out in Appendix II.

Article 5. Procedures for conformity assessment.

The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer among those identified in Article 10.2 of this Regulation. decree, selecting any of the following options:

For mechanical systems:

a) Module B, type examination, plus module D, conformity to type based on quality assurance of the production process.

b) Module B, type examination, plus module E, compliance with the type based on the quality assurance of the instrument.

c) Module B, type examination, plus module F, compliance with type based on instrument verification.

d) Module D1, quality assurance of the production process.

e) Module F1, compliance based on instrument verification.

f) Module G, compliance based on unit verification.

g) Module H1, compliance based on full quality assurance plus design examination.

For electromechanical instruments:

a) Module B, type examination, plus module D, conformity to type based on quality assurance of the production process.

b) Module B, test of type plus module E, conformity to the type based on the quality assurance of the instrument.

c) Module B, test of type plus module F, compliance with type based on instrument verification.

d) Module G, compliance based on unit verification.

e) Module H1, compliance based on full quality assurance plus design examination.

For electronic systems or systems that contain computer programs:

a) Module B, type examination, or more module D, compliance with the type based on quality assurance of the production process.

b) Module B, type examination, plus module F, compliance with type based on instrument verification.

c) Module G, compliance based on unit verification.

d) Module H1, compliance based on full quality assurance plus design examination.

APPENDIX I

Essential Requirements

Section 1. First 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 current voltage continues or the current power limits continue.

1.3 For the magnitudes of mechanical and climatic influence:

The minimum temperature range is 30 ° C, except if specified otherwise in the following sections.

The mechanical environment classes are not applied according to Annex II.

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):

Operation Flow (s).

The characteristics of the product (or products) to be weighed.

2. The permitted effect of the Electromagnetic Environment.

The required performance and the critical change value are shown in the corresponding chapter of this appendix for 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 in normal operation.

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.

Section 2.

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, and XIIII

and,

Y (I), Y (II), Y (a), Y (b)

The manufacturer must specify.

2. Category X of instruments.

2.1 Category X applies to the instruments used to check pre-packages carried out in accordance with the requirements laid down by Council Directive 76 /211/EEC of 20 January 1976 on the approximation of the laws of the Member States on the mass or volume preconditioning of certain instruments in pre-prepared packages⁽¹⁾, applicable to such pre-packages.

(1) OJ L 46, 21.2.1976, p. 1.

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 1 × 10^k, 2 × 10^k , or 5 × 10^k, with k being an integer or zero.

3. Catel items with the value of the weight and price information.

Automatic-run-fill gravimetric instrument: an automatic 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.

Cogory Y of instruments.

The Y category applies to all other automatic weight pickers.

4. Maximum allowed error.

4.1 Average Error of Instruments in Category X/Maximum Error Allowed for Category Y Instruments.

TABLE 1

load (m) at verification s (a)								0.1 g ≤ ei	500	10 000
XIIII	Y (b)	5 g ≤ ei	50	1 000

(1) When i = r, the corresponding column in Table 3 will be used, replacing and by and_r.

Being:

i = 1, 2, ... r

i = weighing partial field

r = total number of partial fields

5. Measure field.

When specifying the measurement field for the instruments in the Y class, the manufacturer must take into account that the minimum scope must not be less than:

class Y (I)

100
class Y (II)	20 e for 0.001 g ≤ e ≤ 0.05 g and 50 e for 0.1 g ≤
class Y (a)	20
class Y (b)	10 and
Balances used for sorting, for example, mailings and waste pagers	5

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 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, those specified in Table 1.

7.1.2 For Category Y instruments:

-For each load on automatic operation, 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 scale interval.

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.

Section 3-Automatic-run-fill 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 A type of instrument is assigned a reference accuracy class, Ref (x), depending on the best possible accuracy for such instruments. Once the individual instruments are installed, they are assigned one or more operating accuracy classes, X (x), taking into account the specific instruments to be weighed. The class designation factor (x) shall be ≤ 2 and respond to the form 1 × 10^k, 2 × 10^k or 5 × 10^k, 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 regime that relates the accuracy to the weight of the load 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 allowed deviation of each filling with respect to the average, as specified in Table 5, multiplied by the class designation factor (x).

2.1.2 For instruments in which the filling can be carried out by one or more loads (e.g. accumulative or selective combing), the maximum error allowed for static weighing shall be the required accuracy for filling as specified in point 2.2 (i.e. not the sum of the maximum deviation allowed for individual loads).

2.2 Deviation to the average fill value.

TABLE 5

%

m ≤ 50

m ≤ 50

of the mass of the mass load m (g)	Maximum allowable deviation of each load
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%
10 000 < m ≤ 15 000	120 g
	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.

2.3 Default value error (tuning error).

For instruments in which a filling weight can be predetermined, the maximum difference between the filling weight and the average mass of the filled-in shall not exceed 0,312 of the

XII

Y (II)

0.001 g ≤ e_i ≤ 0.05 g

5 000

100 000

0.1 g ≤ e_i

5000

100

XIII

Ymaximum permitted deviation of each filling in respect of the average, as set out in Table 5.

3. Operation under influence factors and electromagnetic disturbances.

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 point 2.1 calculated for the minimum nominal fill, or a variation which has an equivalr>

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:

(a) the value calculated according to Table 9, rounded to the nearest scale range,

(b) the value calculated in accordance with Table 9, rounded to the nearest range for a weight equal to 35% of the maximum weight of the wagon (as indicated in the descriptive indications),

c) an interval of scale (d).

2.3 The maximum allowable errors for the weighing in train movement shall be the highest value of the following:

(a) the value calculated according to Table 9, rounded to the nearest scale range,

(b) 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 do not must exceed 10) on the train, rounded to the nearest range of scale,

c) an interval of scale (d) for each train car but not exceeding 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. Scale interval (d).

The relationship between the accuracy class and the scale interval will be the one 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 under influence factors and electromagnetic disturbances.

5.1 The maximum error allowed due to an influence factor will be the one specified in Table 11.

TABLE 11

0 < m ≤ 500

	(m) at verification scale intervals (d)	Maximum allowed error
± 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 scale interval.

APPENDIX II

Technical test procedure for conformity assessment

Test Procedure

The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (existing versions) and/or in the International OIML Recommendations (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission.

Maximum errors allowed

They shall be those listed in Appendix I.

ANNEX VIII

Water Meters

Article 1. Object.

The purpose of this annex is the regulation of the State's metrological control of instruments intended for the measurement of the volume of clean, cold or hot water for residential, commercial or industrial use Lightweight, hereinafter referred to as clean water meters, which are defined below.

Article 2. Definitions.

Water meter: an instrument designed to measure, memorize and indicate the volume, under the measurement conditions, of the water passing through the measurement transducer.

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

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

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

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

Article 3. Metrological control phases.

The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and refers to the marketing and commissioning phase.

Article 4. Essential requirements.

1. The essential requirements to be met by the clean water meters shall be those set out in Appendix I to this Annex.

2. The tests to be carried out for conformity assessment shall be as set out in Appendix II.

Article 5. Procedures for the assessment of conformity.

The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer among those identified in Article 10.2 of this Regulation. decree, selecto">

a) Module B, type examination, plus Module D, compliance with type based on quality assurance of the production process.

b) Module B, type examination, plus Module F, compliance with type based on instrument verification.

c) Module H1, compliance based on full quality assurance plus design examination.

APPENDIX I

Essential Requirements

In addition to the essential requirements described in this Appendix, the corresponding requirements of those set out in Annex II shall apply.

Specific requirements

1. Nominal operating conditions.

The manufacturer shall specify the nominal operating conditions applicable to the instrument, in particular:

1.1 The water flow rate.

The water flow range values must meet the following conditions:

Q₃ /Q₁ ≥ 40.

Q₂ /Q₁ = 1.6.

Q₄ /Q₃ = 1.25.

1.2 The temperature range of the water.

The water temperature range values must satisfy the following conditions:

-0,1 ° C to at least 30 ° C, or

-30 ° C to at least 90 ° C.

1.3 The relative pressure range of water, which will go from 30 kPa to at least 1 MPa to Q₃.

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

2. Maximum errors allowed.

2.1 The maximum permissible, 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.

The counter will not exploit the maximum error allowed nor will it systematically favor either party.

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

The counter will not exploit the maximum error allowed nor will it systematically favor either party.

3. The permitted effect of disturbances.

3.1 Electromagnetic immunity.

3.1.1 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 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 cannot be interpreted, memorized, or transmitted as a result of the measurement.

3.1.2 After an electromagnetic disturbance, the water meter must:

-recover the operating capacity within the maximum allowed error,

-keep all measurement functions in perfect condition,

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

3.1.3 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).

3.2 Durability.

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

3.2.1 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.

3.2.2 The error of indication of the measured volume after the durability test shall not exceed:

± 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.

4. Fitness.

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

4.2 The manufacturer shall specify whether the counter is designed to measure the reverse flow. In such a case, the volume of the reverse flow shall either subtract from the accumulated volume or be recorded separately. Both the normal and reverse flow will apply the same maximum allowed 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.

5. Units of measure.

The measured volume must be indicated in cubic meters.

6. Putting into service.

7. As regards the requirements referred to in paragraphs 1.1.1.2 and 1.3 above, the competent public authorities shall ensure that the properties (flow, temperature and pressure) are determined by the service undertaking. public or by the person legally authorised to install the counter so that the counter is appropriate to accurately measure the intended or foreseeable consumption.

APPENDIX II

Technical test procedure for conformity assessment

Test Procedure

The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (versions in force) or in the International Recommendations OIML (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission.

Maximum errors allowed

Maximum allowable errors are listed in Appendix I.

ANNEX IX

Gas Counters and Volumetric Conversion Devices

Article 1. Object.

The purpose of this annex is the regulation of the State's metrological control of those instruments intended to measure quantities (volumes or masses) of gas, called gas meters, as well as of devices of volumetric conversion, called converters that are defined below for residential, commercial, and light industry use.

Article 2. 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: A device installed on a gas counter that automatically converts the measured quantity into measurement conditions to an amount in base conditions.

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

Maximum flow (Q_max): The highest flow rate at which the gas meter supplies indications respecting the maximum permissible error requirements.

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

Base conditions: conditions specified to which the amount of measured fluid is converted.

Article 3. Metrological control phases.

The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and which refers to the marketing and commissioning phase.

Article 4. Essential requirements.

1. The essential requirements to be met by gas meters and volumetric conversion devices are those set out in Appendix I to this Annex.

2. The technical test procedures to be performed for conformity assessment shall be as set out in Appendix II.

Article 5. Modules for conformity assessment.

The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer from among those identified in Article 10.2 of this Regulation. decree, selecting any of the following options:

a) Module B, type examination, plus Module D, compliance with type based on quality assurance of the production process.

b) Module B, type examination, plus Module F, compliance with type based on instrument verification.

c) Module H1, compliance based on full quality assurance plus design examination.

APPENDIX I

Essential Requirements

In addition to the essential requirements described in this Appendix, the corresponding requirements of those set out in this Annex shall apply to gas meters and volumetric conversion devices. Annex II.

Part I

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:

	accuracy class	Maximum allowable
0.2	± 0.1%
0.5	± 0.25%

Qmax /Qmin	Qmax /Qt	Qr /Qmax
	≥ 150	≥ 10
	1.0	≥ 20	≥ 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 errors allowed.

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

Table 1

	1.5	1.0
min ≤ Q < Qt	3%	2%
Qt ≤ Q ≤ Qmax	1.5%	1%

The gas counter will not exploit the maximum error allowed nor will it systematically favor either party.

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. The 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 cannot 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 maximum allowed error,

-keep all measurement functions in perfect condition,

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

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 upstream or downstream flow disturbances.

In the installation conditions specified by the manufacturer, the effect of flow disturbances shall not exceed one third of the maximum permissible error.

4. Durability.

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

4.1 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 according to paragraph 2.

4.2 Contents of the 1.0 class.

4.2.1 The variation of the measuremeng of the symbols used in this appendix is as follows:

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 = electrical voltage supplied to the counter.

U_n = reference voltage specified.

f = frequency of the voltage supplied to the counter.

f_n = the specified reference frequency.

FP = power factor = cos = the cosine of the phase between I and U.

Specific requirements

1. Accuracy.

The manufacturer must 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 intensity values specified the counter shall meet the conditions set out in Table 1.

TABLE 1

		Class A	Class B	Class C
For directly attached counters
st	≤ 0.05-Itr	≤ 0.04- Itr	≤ 0.04-Itr
min	≤ 0.5- Itr	≤ 0.5-Itr	≤ 0.3-Itr
	≥ 50-I	≥ 50- Itr	≥ 50-Itr
transformer-attached counters
st	≤ 0.06-Itr	≤ 0.04-Itr	≤ 0.02-Itr
	≤ 0.4-Itr	≤ 0.2-Itr (*)	≤ 0.2-Itr
n	= 20-Itr	= 20-Itr	= 20-Itr
	≥ 1,2-In	≥ 1,2-In	≥ 1,2-In

^(*) For the electromechanical counters in 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 power factor (FP) interval will be, at least, from cos = 0.5 inductive to cos = 0.8 capacitive.

3. Maximum errors allowed.

The effects of the different measurands and the different influence measures (a, b, c, ...) are assessed separately, keeping relatively constant in their reference values all other magnitudes subjected to measurement and magnitude of influence. The measurement error, which shall not exceed the maximum permissible error indicated in Table 2, shall be calculated as follows:

Measurement error =

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.

		Operating temperatures Interior placement and exterior			Operating temperatures Inner placement			Operating temperature Outer
		+ 5 ° C ... + 30 ° C			-10 ° C ... + 40 ° C			-25 ° C ... + 55 °
	Counter Class.	A	B	C	Module B, type examination, plus module F, declaration of conformity to the model based on instrument verification, or c) Module H1, compliance statement based on total quality assurance plus design examination. APPENDIX I Essential Requirements In addition to the essential requirements described in this Appendix, the corresponding requirements of those set out in Annex II shall apply. Symbols used: The meaninminal operating conditions. The manufacturer shall specify the values of the nominal operating conditions as follows: 1.1 Liquid temperature: θmax, θmin, -temperature differences: Δθmax, Δθmin, with the following limitations: Δθmax /Δθmin ≥ 10; Δθmin = 3 K or 5 K or 10 K. 1.2 Liquid pressure: the maximum positive internal pressure that the thermal energy meter can permanently withstand to the upper temperature limit. 1.3 Liquid Caudals: qs, qp, qi, with the values of qp and qi subject to the following limitation: qp /qi ≥ 10. 1.4 Thermal power: Ps. 2. Accuracy classes. The following accuracy classes have been defined for thermal energy counters: 1, 2, 3. 3. Maximum allowable errors applicable to fullr. For specific purposes, the competent Public Administration may require the use of any counter of the class C. (c) The competent Public Administration shall ensure that the electrical current intensity interval 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. d) For the purpose of putting into service and in accordance with Article 12.2 of this royal decree, the following temperature margins are established according to the type of site concerned: Counters installed in inner placement. -10 ° C to + 40 ° C Counter-installed counters. -25 ° C to + 55 ° APPENDIX II Testing procedure for conformity assessment The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (versions in force) or in the International Recommendations OIML (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission. Maximum errors allowed Maximum allowable errors are listed in Appendix I. ANNEX XI Thermal Energy Counters Article 1. Object and scope of application 1. The purpose of this Annex is to regulate the metrological control of the State of those instruments intended to measure thermal energy, hereinafter referred to as thermal energy meters, as defined in Article 2. 2. The specific requirements and conformity assessment procedures listed in this Annex shall apply to thermal energy meters for residential, commercial and light industrial use. Article 2. Definitions. Thermal energy meter: an instrument designed to measure thermal energy that, in a thermal exchange circuit, yields a liquid called the thermal energy transmitter. 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 (av) of this royal decree; or of a combination of these. Article 3. Metrological control phases. 1. The metrological control of the State established in this Annex is the one that is regulated in Section 3. of Chapter III of this royal decree and which refers to the phase of marketing and putting into service. Article 4. Essential requirements. 1. The essential requirements to be met by the thermal energy meters shall be those set out in Appendix I to this Annex. 2. The tests to be carried out for conformity assessment shall be as set out in Appendix II to this Annex. Article 5. Modules for conformity assessment. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer among those identified in Article 10.2 of this Regulation. decree, selecting any of the following options: a) Module B, type examination, plus Module F, compliance with type based on instrument verification. b) Module B, type examination, plus Module D, conformity to type based on quality assurance of the production process. c) Module H1, compliance based on full quality assurance plus design examination. APPENDIX I Essential Requirements In addition to the essential requirements described in this appendix, the corresponding requirements of those set out in Annex II to this royal decree shall apply. Symbols used: The meaning of the symbols used in this appendix is as follows: θ = the temperature of the thermal energy transmitter. θin = the value of θ at the input of the thermal energy exchange circuit. θout= the value of θ at the output of the thermal power exchange circuit. θ θ = the temperature difference θin -θout, with the following : θmax= the maximum limit of θ for the thermal energy counter to function correctly within the maximum allowable errors. θmin= the minimum limit of θ for the thermal energy counter to function correctly within the maximum allowable errors. max. θmax= the maximum limit of the θ θ for the thermal energy counter to function correctly within the maximum allowable errors. {\expndtw-2} {\expndtw-2} {\expndtw-2} {\expndtw-2} {\expndtw-2} {\expndtw-2{\ q = the flow of the thermal energy transmitter liquid. qs = the highest value of q allowed for short periods of time for the counter to function correctly. qp= the highest value of q that is permanently allowed for the thermal energy counter to function correctly. qi = the lowest q value that is allowed for the thermal power counter to work correctly. P = the thermal power of the thermal energy exchange. Ps= the maximum allowed limit of P for the thermal power counter to function correctly. 1. No> 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 when the counter works for 4 000 hours at full load (I = Imax, U = Un and FP = 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 e class="ning_n_estilo_de_tabla" summary="Tabla de formato"> Accuracy 0.3 0.5 1.0 1.5 2.5 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: 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 (Qmin) and the maximum flow rate (Qmax). Article 3. Metrological control phases. The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and refers to the marketing and commissioning phase. Article 4. Essential requirements. 1. The essential requirements to be met by the measurement systems shall be those set out in Appendix I. 2. The tests to be carried out for conformity assessment shall be as set out in Appendix II. Article 5. Modules for conformity assessment. 1. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer from among those identified in Article 10.2 of this royal decree, by selecting any of the following options: a) Module B, type examination, plus Module F, compliance with type based on instrument verification. b) Module B, type examination, plus Module D, conformity to type based on quality assurance of the production process. c) Module H1, compliance based on full quality assurance plus design examination. d) Module G, compliance based on unit verification. APPENDIX I Essential Requirements In addition to the essential requirements described in this Appendix, the corresponding requirements of those set out in Annex II shall apply. If applicable, in this Appendix, the terms "volume" and "litre" can be read, respectively, as "mass" and "kg". Specific requirements 1. Nominal operating conditions. The manufacturer shall specify the nominal operating conditions of the instrument, in particular: 1.1 Flow interval. The flow rate is subject to the following conditions: i) The flow rate 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 5: 1 Measurement System Liquid Features Qmax Q Q Non-liquefied gases. 10: 1 Gases liquefied. 5: 1 system. : 1 5: 1 5: 1 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 the power alternating current voltage, power supply voltage limits, 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 12 (2) of Council Directive 2003 /96/EC of 27 October 2003 for the restructuring of the Community system for the taxation of energy products and electricity (OJ L 283 of 31 October 2003, page 51). 2. Classification of the maximum allowable accuracy and errors. 2.1 For quantities equal to or greater than two litres the maximum error allowed in the indications is: TABLE 2 Associated measuring instrument: instrument connected to the calculator to measure certain magnitudes that are characteristic of the liquid, in order to make a correction or conversion. Conversion device: a part of the calculator which, taking into account the characteristics of the liquid (temperature, density or other magnitudes) measdifferent, the deviation shall not be greater than the largest range of scale. However, in the case of a self-service mode, the scale intervals of the measurement system main indicator device and the scale intervals of the self-service device must be the same and not Any deviation from the recorded measurement results shall occur. 5.2 It should not be possible to divert the measured quantity under normal conditions of use, unless this is clearly stated. 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 whose viscosity 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 sales. 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 Surters. 5.5.1 During measurement, it will not be possible to reset the fuel pump 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 Emin. However, this difference is not required to be less than the minimum denomination of the monetary unit. 6. Power supply interruption. The measurement systems shall either be equipped with an emergency device for the supply of electricity that safeguards all the measurement functions during the interruption of the main power source, 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 supply of the source is interrupted power. 7. Putting into service. TABLE 5 accuracy class Measurement system 0.3 Pipeline measurement systems. 0.5 All systems not specifically listed in this box, in particular: - fuel dispensers (except liquefied gases). -measurement systems in tank trucks for low-viscosity liquids (≤ 20 mPa-s). -measurement systems for (des) loading Ships, wagons and tankers. -measuring systems for milk. -measurement systems for resupply of aircraft 1.0 Measurement systems for gases liquefied under pressure measured at a temperature equal to or greater than -10 °C. The measurement system that normally corresponds to the class 0.3 or 0.5 but used for liquids: - temperature is less than -10 °C or more than 50 °C. -whose dynamic viscosity is greater than 1 000 mPa-s. -the maximum volumetric flow rate not exceeding 20 l/h. 1.5 Measurement Systems 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 better accuracy for certain types of measurement systems. 8. Units of measures. The measured amount will be presented in millilitres, cubic centimeters, liters, cubic meters, grams, kilograms, or tons. APPENDIX II Technical test procedure for conformity assessment Test Procedure The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (versions in force) or in the International Recommendations OIML (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission. Maximum errors allowed Maximum allowable errors are listed in Appendix I. ANNEX XIII Taximeters Article 1. Object. The purpose of this annex is to regulate the metrological control of the state of those instruments intended to measure the elapsed time and to calculate the distance based on a signal sent by the signal generator. distance and calculate and indicate visibly the amount to be paid for a journey based on the calculated distance, the measured duration of the journey, or both, hereinafter referred to as 'taximeters' and defined in Article 2. Article 2. Definitions. Taximeter: a device that works together with a signal generator (which is not included in the scope of the present royal decree) to constitute a measuring instrument. The device measures the elapsed time and calculates the distance traveled 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. Amount of service: total amount of money that is paiby the manufacturer, the following criterion must be met: The variation of the measurement result after the durability test when compared to 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 range interval when the range of the the devices have the same value. If d for a journey, based on an initial fixed rate and/or the distance and/or the duration 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 corresponding to the temporary rate by the value corresponding to the rate based on the distance. 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 ity assurance of the production process. g) Module H, compliance based on full quality assurance. APPENDIX I Essential Requirements In addition to the essential requirements described in this appendix, the corresponding requirements of those set out in Annex II of this royal decree shall apply. However, it must be borne in mind that the declarations of conformity of the materialised measures may be applied to a whole consignment or consignment and not to separfo">-the time of day, -the date, -the day of the week. 16. 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. 17. 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. 18. 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. 19. 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. 20. 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. 21. 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 clock correction capability 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. 22. The values of the distance travelled and of the elapsed time, when displayed or printed according to the present 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. 23. Maximum errors allowed. Maximum allowed errors, excluding any errors due to the application of the taximeter in a taxi, are: -For the 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. APPENDIX II Technical test procedure for conformity assessment Test Procedure The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (versions in force) or in the International Recommendations OIML (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission. Maximum errors allowed Maximum allowable errors are listed in Appendix I. ANNEX XIV Materialized measures Article 1. Object. The purpose of this annex is the regulation of the State's metrological control of the materialised measures of length and of the measures of capacity to serve as defined in Article 2. Article 2. Definitions. Materialized measure of length: an instrument composed of a scale whose distance between traces is indicated in legal units of length. Measure of capacity to serve: 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 consumption immediate. Trace measure: a measure of capacity that is provided with a stroke indicating the nominal capacity. Stop measure: a measure of capacity in which the internal volume is equal to the nominal capacity. Trasiego measure: a measure of capacity from which a liquid is poured before its consumption. Capacity: The capacity is the internal volume for the stop measures or the internal volume up to the trace in the stroke measures. Article 3. Metrological control phases. The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and refers to the marketing and commissioning phase. Article 4. Essential requirements. The essential requirements to be met by the materialised measures shall be those set out in Appendix I. Article 5. Modules for conformity assessment. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 of this Annex shall be chosen by the manufacturer from among those set out in Article 10.2 of this Annex. this royal decree, selecting any of the following options: Materialized measures of length: a) Module F1, compliance based on product verification. b) Module D1, quality assurance of the production process. c) Module B, type examination, plus module D, conformity to type based on quality assurance of the production process. d) Module H, compliance based on full quality assurance. e) Module G, compliance based on unit verification. Capacity measure to serve: a) Module A2, internal control of the production plus monitored control of the instruments at random intervals. b) Module F1, compliance based on instrument verification. c) Module D1, quality assurance of the production process. d) Module E1, quality assurance of inspection and testing of the finished instrument. e) Module B, type examination, plus module E, compliance with the type based on the quality assurance of the instrument. f) Module B, type examination, plus module D, conformity to type based on qualovided 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 8 under conditions of power sing 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 Lambda. -Lambda is a dimension lacking value that represents the combustion efficiency of an engine in terms of air/fuel ratio in exhaust gases. It is determined by reference to a normalized formula. Article 3. Metrological control phases. The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and refers to the marketing and commissioning phase. Article 4. Essential requirements. 1. The essential requirements to be met by the exhaust gas analysers shall be those set out in Appendix I. 2. The tests to be carried out for conformity assessment shall be as set out in Appendix II. Article 5. Modules for conformity assessment. 1. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer from among those identified in Article 10.2 of this royal decree, by selecting any of the following options: a) Module B, type examination, plus module D, conformity to type based on quality assurance of the production process. b) Module B, type examination, plus module F, compliance with type based on instrument verification. c) Module H1, compliance based on full quality assurance plus design examination. APPENDIX I Essential Requirements In addition to the essential requirements described in this Appendix, the corresponding requirements of those set out in Annex II shall apply. Instrument classes 1. Two classes of instruments, 0 and I, are defined for exhaust gas analyzers. The measurement fields for those classes are as shown in Table 1. Table 1. Measurement classes and ranges K Valuo_2">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 as not to prevent the full discharge of the measured liquid. 5. Marked. 5.1 The declared nominal capacity must be clearly and indelibly marked in the measure. 5.2 Measures of capacity to serve 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 during use. APPENDIX II Technical test procedure for conformity assessment Test Procedure The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (versions in force) or in the International Recommendations OIML (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission. Maximum errors allowed Maximum allowable errors are listed in Appendix I. ANNEX XV Instruments for dimensional measures Article 1. Object. The purpose of this Annex is to regulate the metrological control of the State of the instruments for dimensional measures of the types defined in Article 2. Article 2. Definitions. 1. 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 to be measured. 2. Area measurement instruments. An area measuring instrument serves for the determination of the area of irregularly shaped objects, for example leather. 3. Instruments for multidimensional measures. An instrument for multi-dimensional measures serves to determine the length of the edges (length, height, width) of the smallest rectangular parallelepiped that marks a product. Article 3. Metrological control phases. 1. The metrological control of the State set out in this Annex is the one that is regulated in Section 3 of Chapter III and which refers to the marketing and commissioning phase. Article 4. Essential requirements. 1. The essential requirements to be met by the instruments for dimensional measures shall be those set out in Appendix I. 2. The tests to be carried out for conformity assessment shall be as set out in Appendix II. Article 5. Modules for conformity assessment. 1. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by the manufacturer from among those identified in Article 10.2 of this royal decree, by selecting any of the following options: For mechanical or electromechanical instruments: a) Module F1, compliance based on instrument verification. b) Module E1, quality assurance of inspection and testing of the finished instrument. c) Module D1, quality assurance of the production process. d) Module B, type examination, plus module F, compliance with type based on instrument verification. e) Module B, type examination, plus module E, compliance with the type based on the quality assurance of the instrument. f) Module B, type examination, plus module D, conformity to type based on quality assurance of the production process. g) Module H, compliance based on full quality assurance. h) Module H1, compliance based on full quality assurance plus design examination. i) Module G, compliance based on unit verification. For electronic instruments or instruments that include software: a) Module B, type examination, plus module F, compliance with type based on product verification. b) Module B, type examination, plus Module D, conformity to type based on quality assurance of the production process. c) Module H1, compliance based on full quality assurance plus design examination. d) Module G, compliance based on unit verification. APPENDIX I Essential Requirements Section 1. Requirements common to all instruments for dimensional measures In addition to the essential requirements described in this Appendix, the corresponding requirements of those set out in Annex II shall apply. 1. Electromagnetic immunity. 1.1 The effect of an electromagnetic disturbance on an instrument for dimensional measurements shall be such that: -the change in the measurement result does not exceed the critical change value defined in point 1.2, -be impossible to perform any measurement, -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 all stakeholders to be aware of the results of the measurement. 1.2 The change critical value will be equal to a scale interval. Section 2. 1. Characteristics of the product to be measured. 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 is the weight per surface unit of a fabric sample in N/m2. 2. Operat ≥ 100 ml ± 3% -0 + 6% Measures to serve: < 200 ml ± 5% -0 + 10% Parameter Classes 0 and I CO From 0% vol to 5% vol. 2 Fraction From 0% vol to 16% vol. Fraction Fraction of O2 From 0% vol to 21% vol. λ from 0.8 to 1.2. Nominal operating conditions 2. The manufacturer shall specify the nominal operating values as follows: 2.1 For the values of climate and mechanical influences: -A minimum temperature range of 35 ° C for the climate environment. -The applicable mechanical environment class is the M1. 2.2 For the values of the influence of electrical energy: -The voltage and frequency intervals for the supply of alternating current voltage. -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 ≥ 1 060 hPa. Maximum errors allowed 3. Maximum allowable errors are defined below: 3.1 For each of the measured fractions, the maximum value of the error allowed under nominal operating conditions in accordance with Article 3 (1.1) of Annex II in which the essential requirements are collected The absolute values are expressed in% vol or in ppm vol, the percentage values being the percentage of the real value. Table 2. Maximum errors allowed Parameter Faction 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% 2 Fraction ± 0.1% vol ± 5% ± 0.1% vol ± 5% 3.2 The maximum error allowed in the lambda calculation is 0.3%. The true conventional value is calculated according to the formula set out in point 5.3.7.3 of Regulation No 83 of the Economic Commission for Europe of the United Nations (UN/ECE) published in OJ L 42 of 15 February 2012, p.1. and which is listed below: Where: [] = concentration in% vol. K1 = conversion factor of the measurement of the non-dispersive infrared analyzer to the measurement of the flame ionization detector (facilitated by the manufacturer of the measurement equipment). Hcv = hydrogen/carbon atomic ratio (for gasoline (E5) the value of this parameter is 1.89). Ocv = oxygen/carbon atomic ratio (for gasoline (E5) the value of this parameter is 0.016). To this end, the values presented by the instrument are used for the calculation. Allowed effect of disturbances 4. For each of the volume fractions measured by the instrument the criticicle. engine with spark ignition at the moisture limit of the test sample. These components of gases are carbon monoxide (CO), carbon dioxide (CO2), oxygen (O2) and hydrocarbons (HC). The hydrocarbon content must be expressed as concentration of n-hexane (C6H14) measured with new techniques of near-infrared absorption. The volume fractions of the gas components are expressed as a percentage (% vol) for CO, CO2 and O2 and parts per million (ppm vol) for HC. In addition, an exhaust gas analyser calcal 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 the 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 CO2 2 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 maximum permissible error module for each applicable gas volume fraction. 8. In order to measure CO, CO2 and HC, the instrument including the specified gas circulation system shall indicate 95% of the final value as determined by the calibration gases within 15 seconds of 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 exhaust gases other than the component whose value is subject to measurement shall not affect the result of the measurement in more than half of the modules of the maximum permissible errors, when those components are present in the The following maximum volume fractions: 6% vol CO, 16% vol CO2, 10% vol Or2, 5% vol H2, 0.3% vol NO, 2 000 ppm vol HC (as n-hexane), water vapor: to saturation. 10. An exhaust gas analyser shall have an adjustment device for the operation of the exhaust, calibration of the gases and internal adjustment. Said set-to-zero and internal adjustment device will be automatic. 11. In the case of automatic, or semi-automatic adjustment devices, the instrument shall not be able to carry out a measurement until the adjustments have been completed. 12. An exhaust gas analyser shall detect hydrocarbon residues in the gas circulation system. It shall not be possible to carry out a measurement if the concentration of residual hydrocarbons present before a measurement exceeds 20 ppm vol. 13. An exhaust gas analyser shall have a device which allows the automatic recognition of any defective operation of the oxygen channel sensor due to wear or tear on the connecting line. 14. If the exhaust gas analyser can be operated with different fuels (e.g. petrol or liquefied gas), the appropriate coefficients for the calculation of the lambda without any ambiguity in relation to the exhaust gas analyser must be selected. appropriate formula. APPENDIX II Technical test procedure for conformity assessment Test Procedure The technical testing procedure for conformity assessment and the necessary technical means will depend on the technical solution applied by the manufacturer, and can be applied as described in the rules harmonised (versions in force) or in the International Recommendations OIML (regulatory documents in force), taking into account the references to the essential requirements published by the European Commission. Maximum errors allowed Maximum allowable errors are listed in Appendix I. Search Translated Laws of Spain Search Advertising for Lawyers Privacy Terms