Key Benefits:
Law 3/1985, of 18 March, of Metrology, as amended by Royal Decree-Law 1296/1986 of 28 June 1986, in order to adapt it to Community secondary legislation, establishes the legal system of metrological activity in Spain, which must be subject, in defence of security, to the protection of the health and economic interests of consumers and users, the instruments, apparatus, means and systems of measurement, which serve to weigh, measure or count, among which include the non-automatic weighing instruments.
Following the accession of Spain to the European Communities, a number of Community Directives were incorporated into Spanish national law, which were issued in accordance with Directive 71 /316/EEC of 26 July and their amendments on the provisions common to measuring instruments and methods of metrological control. These include, as far as the non-automatic weighing instruments are concerned, Directive 73 /360/EEC of 19 November, as amended by 76 /696/EEC of 27 July and 82 /622/EEC of 1 July. These Directives were incorporated into Spanish national law by the Order of Public Works and Urbanism of 28 December 1988 (Official Gazette of the State of 27 February 1989).
The non-automatic weighing instruments were the subject of a new Community regulation through Directive 90 /384/EEC of 20 June, which is incorporated into Spanish national law by the Order of the Ministry of Public Works and Transport of 24 November 1992 (Official Journal of the State of 18 December 1992). This Directive has been amended by Directive 93 /68/EEC of 22 July 1989 as a sequence of the Council Resolution of 21 December 1989 on a global approach to conformity assessment for all Member States. Directives and the creation of common rules concerning an EC market in accordance with a single logo.
Therefore, it is necessary to amend the Order of 24 November 1992 regulating the EEC metrological control of non-automatic weighing instruments. However, in view of the large number of amendments made to the aforementioned Order, the adoption of a new Order has been chosen in order to unify in a single text the regulation of these instruments.
Consequently, the purpose of this Order is to incorporate into Spanish national law the amendments to Directive 90 /384/EEC introduced by Directive 93 /68/EEC, by virtue of the provisions laid down by the provision The first of the Royal Decree 597/1988 of 10 June 1988 regulating the metrological control of the EEC.
In its virtue, I have:
Article 1. Object.
The purpose of this Order is to determine the necessary conditions to be met by the non-automatic weighing instruments, for the purposes of their adaptation and the declaration of their conformity with the Community prescriptions.
Article 2. Definitions.
By weighing instrument, a measuring instrument is understood to be used to determine the value of the mass of a body using the action of gravity on that body, and may also serve to determine other quantities, quantities, parameters or mass-related characteristics.
By means of non-automatic weighing instrument a weighing instrument is understood which requires the intervention of an operator in the course of the weighing.
Article 3. Use of the non-automatic weighing instruments.
For the purposes of this Order, two fields of use of the non-automatic weighing instruments shall be distinguished:
a) For the determination of the mass of a body for the following purposes:
Performing business transactions.
Calculation of fees, duties, taxes, premiums, fines, remuneration, allowances and other similar fees.
Application of rules or regulations, as well as conduct of judicial expertise.
Weighing patients for reasons of control, diagnosis, and medical treatment.
Pharmaceutical preparation of medicines by order, as well as carrying out analyses carried out in the medical and pharmaceutical laboratories.
Determination of the price or total amount in direct sale to the public and prepackaged preparation.
b) For the determination of the mass of a body for purposes other than those specified in point (a) above.
Article 4. Conditions for placing on the market and putting into service.
1. Only the instruments in which it is visible, easily legible to indelible, the name of the manufacturer and the maximum extent represented by Max ...
may be placed on the market.2. For the uses referred to in Article 3 (a), only instruments which meet the essential requirements laid down in Annex 1 may be put into service and which, for that reason, bear the CE marking referred to in Article 3 (1). Article 7 of this Order and the conformity of which has been established in accordance with the conformity checking procedures set out in Annex II.
3. If the instrument consists of or is connected to devices that are not used for the applications referred to in Article 3 (a), those devices shall not be subject to the essential requirements of Annex I.
Article 5. Compliance check.
1. The conformity of the non-automatic weighing instruments with the essential requirements set out in Annex I shall be verified by any of the following procedures, at the choice of the applicant:
(a) The EC approval of a model as set out in point 1 of Annex II, followed either by the EC declaration in accordance with the model (guarantee of production quality), as referred to in point 2 of the said Annex, or of the EC verification, as set out in point 3 of the same Annex.
Model EC approval will not be mandatory for instruments that do not use electronic devices and whose load meter device does not use springs to balance it.
(b) EC verification per unit, as set out in point 4 of Annex II.
2. Conformity with the essential requirements set out in Annex I of those instruments which comply with national rules which in turn apply or are referred to in the harmonised standards published in the Official Journal of the European Communities is presumed to be European ", which also meet the above essential requirements.
Article 6. Notified bodies.
1. Verification of conformity by any of the procedures referred to in the previous Article shall be carried out by bodies which comply with the requirements of Annex V, point 1 and which are officially recognised for that purpose.
2. The competent public authority shall, after having verified compliance with the requirements referred to in the preceding number, give a decision by setting up the body, establishing its composition and the metrological control activities to be carried out. perform.
3. If a body fails to comply with the requirements for recognition, the competent public administration shall, after hearing the body, decide to revoke its constitution.
Article 7. CE conformity marking, identification number of the notified body and inscriptions.
1. The CE conformity marking, the identification number of the notified body and the inscriptions referred to in point 1 of Annex IV, shall be clearly visible and easily legible and indelible on the instruments whose CE conformity has been checked.
2. The inscriptions referred to in point 2 of Annex IV shall appear in all the instruments referred to in Article 3 (b), in a clearly visible and easily legible and indelible form.
3. It shall be prohibited to place marks on the instruments which may mislead third parties in relation to the meaning or the logo of the CE marking. Any other mark may be affixed to the instrument, provided that it does not reduce the visibility or legibility of the CE marking.
4. Where other Community Directives providing for the affixing of the CE marking are applicable to the instruments, this shall indicate that the instruments also comply with the provisions of those Directives.
However, should one or more of those Directives apply to the instruments to allow the manufacturer to choose, during a transitional period, the system to be applied, the CE marking shall only indicate compliance with the provisions of the Directives applied by the manufacturer. In this case, the references of the Directives applied, as published in the Official Journal of the European Communities, must be included in the documents, brochures or instructions required by those Directives and accompanying them. instruments.
Article 8. Non-compliance with the essential requirements.
1. Where the competent Public Administration considers that the instruments bearing the CE conformity marking referred to in points 2, 3 and 4 of Annex II do not comply with the requirements of this Order, even if they have been correctly installed and used for the purposes for which they are intended, shall take all appropriate measures to remove them from the market, and may also prohibit or restrict their placing in service and their placing on the market, as well as the appropriate measures against those responsible for the fixing of said marking, informing the Spanish Metrology Center about the adoption of those measures for the purpose of their immediate communication to the Commission of the European Union, indicating the reasons for their decision, and in particular whether the lack of conformity is derived:
(a) failure to comply with the essential requirements referred to in Article 4, in cases where the instruments do not comply with the standards referred to in Article 5 (2
;(b) an incorrect application of the rules referred to in Article 5 (2
;(c) of gaps in the rules referred to in Article 5 (2
.Article 9. Incorrect placement of CE marking.
Where the competent public authority finds that the CE marking has been affixed incorrectly, the manufacturer or his authorised representative established within the European Union shall be obliged to replace the marking of the instrument. in accordance with the provisions of this Order.
If the manufacturer or his authorised representative established in the European Union does not comply with the obligation referred to, the competent public administration shall take all necessary measures to restrict or prohibit the placing on the market of the instrument or withdraw it from the market, as set out in the previous article.
Article 10. Restrictive symbol of use.
If an instrument used in any of the applications referred to in Article 3 (a) consists of or is connected to devices which have not been subject to the conformity check as set out in Article 5, each of these devices shall bear the restrictive symbol of use as defined in point 3 of Annex IV. The symbol shall be clearly visible or indelible on the devices.
Additional disposition.
The constitutive resolution of a notified body, referred to in Article 6 (2), shall be communicated to the Spanish Metrology Centre, who shall, through the Secretariat of State for the European Communities, notify the Commission, the other Member States and the relevant national and international organisations, the relationship of the notified bodies and the specific tasks for which each of them has been designated. The Commission shall assign them identification numbers.
The revocation of a notified body shall also be communicated to the Spanish Metrology Centre, who, through the Secretariat of State for the European Communities, shall notify the Commission of such revocation, other Member States and the organisations to which it was notified.
Transitional disposition.
Early verification and placing on the market and in service of instruments manufactured in accordance with model approvals obtained prior to 1 January 1993 may be carried out until 31 December 1993. of 2002 in accordance with the provisions of Chapters I, II, III and V of the Annex to the Order of the Ministry of Public Works and Urbanism of 28 December 1988. In addition, and up to that date, amendments and extensions to the models approved before 1 January 1993 may be made in accordance with the same chapters in the Annex to the Order.
The placing on the market and putting into service of the instruments marked in accordance with the systems established by the Order of 24 November 1992 can only be carried out until 1 January 1997.
Repeal provision.
Without prejudice to the provisions of the transitional provision, the Order of the Ministry of Public Works and Transport of 24 November 1992 regulating the metrological control of the instruments of the Non-automatic weighing.
Final disposition.
This Order will enter into force on January 1, 1995.
Madrid, 22 December 1994.
BORRELL FONTELLES
ANNEX I
Essential Requirements
The essential requirements to be met by the instruments referred to in Article 3 (a) shall be as set out below. The terminology used is that of the International Organization of Legal Metrology.
Preliminary observation. -If the instrument consists of or is connected to more than one indicator or printer device that is used for the applications referred to in Article 3 (a), those devices which 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, provided that the results of the weighing are printed or recorded correctly and indelibly by a part of the instrument that meets the essential requirements and is accessible to both parties interested in 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.
Metrological prescriptions
1. Units of mass. -The units of mass to be used are the legal units of measure established in Royal Decree 1317/1989, of 27 October.
The authorized units are subject to the above conditions:
SI units: kilogram, microgram, milligram, gram, tonne.
Other units: metric carat, for weighing precious stones.
2. Precision classes.
2.1 The following precision classes are defined:
Special [I]
Fine [II]
Media [III]
Ordinary [IIII]
In table 1 below, these classes are specified.
TABLE 1
Precision classes
| Escalon verification (e) |
Minimum Scope (Min) Minimum Value - e | Number of Verification steps n = Max/ | ||
|---|---|---|---|---|
| Minimum Value - Pesetas | Maximum value - Pesetas | |||
|
I] | 0.001 g ≤ e | 100 | 50,000 |
- |
| [II] | 0,001 g ≤ e ≤ 0,05 g | 20 | 100 | |
|
| 0.1 g ≤ e | 50 | 5,000 | |
| g ≤ e ≤ 2 g | 20 |
100 | ||
|
| 5g ≤ e | 20 | 500 | 10,000 |
|
[IIII] | 5g ≤ e | 10 | 100 | 1,000 |
For instruments of classes [II] and [III] that serve to determine a transport rate, and minimum scope is reduced to 5 e.
2.2 Escalations.
2.2.1 The actual step (d) and the verification step (e) shall correspond to:
1 × 10k, 2 × 10k or 5 × 10k 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 × 10kg
d < e ≤ 10 d
except for instruments of class [I] with
d < 10-4 g, for which e = 10-3 g.
3. Classification.
3.1 Instruments with a single weighing field. -Instruments with auxiliary indicator device shall correspond to classes [I] or [II] The lower limit of the minimum range of instruments of these two classes is obtained from from Table 1, by replacing the verification step (e) of the third column by the actual step (d).
If d < 10-4 g, the maximum scope of the 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 precision classes, the instrument shall meet the most stringent requirements applicable to the precision classes to which the passage fields correspond.
3.3 Multirange Instruments.
3.3.1 Instruments with a single weighing field may have several partial weighing fields (multi-range instruments).
Multi-range instruments must not carry any auxiliary indicator devices.
3.3.2 Each partial weighing field and multi-range instruments is defined by:
your verification step andi : e(i + 1) ] ei
max max reachi : Maxr = Max
your Mini minimum scope: Mini = Max(i-1), and Min1 = Min
where:
i = 1, 2, ... r
i = number of weighing partial fields
r = total number of weighing partial fields
All scopes are understood to be referred 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 precision, that is, the kind of precision 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
| Escalon verification (e) |
Minimum Scope (Min) Minimum Value - e | Number of Verification | ||
|---|---|---|---|---|
|
value (1) n = Maxi /e(i + 1) - Pesetas | Maximum value n = Maxi / ei - Pesetas | |||
|
I] | 0.001 g ≤ ei |
100 | 50,000 |
- |
| [II] | 0.001 g ≤ ei ≤ 0.05 g | 20 | 5,000 | 100,000 |
|
| 0.1 g ≤ ei | 50 | 5,000 | 100,000 |
|
[III] | 0.1 g ≤ ei | 20 |
500 | 10,000 |
| [IIII] | 5g ≤ ei |
10 | 50 | 1,000 |
(1) When i = r the corresponding column in Table 1 will be applied, replacing e by ei.
4. Accuracy.
4.1 In the application of the procedures referred to in Article 5 (1), the error of indication shall not exceed the maximum permissible error indicated in Table 3. If this is a numeric 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 the default tare values.
TABLE 3
Maximum errors allowed
|
| Maximum error allowed | |||
|---|---|---|---|---|
| Class [I] | Class [II] | Class [III] | Class [IIII] | |
|
0 ≤ m ≤ 50,000 e | 0 ≤ m ≤ 5,000 e | 0 ≤ m ≤ 500 e | 0 ≤ m 50 e | ± 0.5 |
| 50,000 e < m ≤ 200,000 e | 5,000 e < m ≤ 20,000 e | 500 e < m ≤ 2,000 e | 50 e < m ≤ 200 e | ± 1.0 |
| 200,000 e < m |
20,000 e < m ≤ 100,000 e | 2,000 < m ≤ 10,000 e | 200 e < m ≤ 1,000 e | ± 1.5 |
4.2 The maximum errors allowed in service will be double the maximum allowable errors set by 4.1.
5. Results of the heavy ones. -The results of the heavy ones of an instrument must be repeatable and reproducible by the different devices of indication use in the instrument and according to the methods of balanced used.
The results of the heavy ones must be sufficiently insensitive to the changes of site of the load on the load receiving device.
6. The instrument shall react to small variations in the load.
7. Magnitudes of influence and time.
7.1 The instruments of classes [II], [III] and [IIII], which can be used in a tilted position, shall be sufficiently insensitive to the inclination that may occur in normal operation.
7.2 The instruments must satisfy the metrological characteristics within the temperature range specified by the manufacturer. The value of this interval will be at least equal to:
5 ° C for an instrument of class [I].
15 ° C for an instrument of class [II].
30 ° C for an instrument of classes [III] or [IIII].
If it is not specified by the manufacturer, the temperature range from -10 ° C to +40 ° C.
7.3 The instruments that operate connected to the electrical grid shall satisfy the metrological characteristics under feeding conditions within the limits of normal fluctuations.
Battery-operated instruments should point to any voltage drop below the required minimum, and in this case, they must continue to function correctly or be automatically disconnected.
7.4 Electronic instruments, except for classes [I] and [II] for which "e" is less than 1 g, shall satisfy the metrological characteristics under conditions of high relative humidity at the upper limit of their range temperature.
7.5 The loading of an instrument of classes [II], [III] or [IIII] over a long period of time shall not have a significant influence on the indication of the load or on the indication of zero immediately after the removal of the load.
7.6 In other conditions the instruments will continue to function correctly or will be automatically disconnected.
Design and Build
8. General conditions.
8.1 The design and manufacture of the instruments will have to be carried out in such a way that they retain their metrological qualities if they are used and installed properly and if they work in the medium for which they have been designed. The value of the mass must be indicated.
8.2 If they are exposed to disturbances, electronic instruments shall not charge significant failures or detect and clearly identify and point to them.
When a significant failure is automatically detected, electronic instruments will cause a visual or sound alarm, which should persist until the user corrects the failure or disappears.
8.3 The conditions set out in points 8.1 and 8.2 shall be met on a permanent basis for a normal period of time, in accordance with the use of these instruments.
Digital electronic devices will always exercise proper control of the correct operation of the measurement process, the indicator device, as well as the storage and transfer of the data.
In the case of automatic detection of a significant durability error, electronic instruments must issue a visual or sound signal that must persist until the user takes the appropriate corrective measures or even The error will disappear.
8.4 When an external equipment is connected to an electronic instrument by means of an appropriate interface, this shall not prejudice the metrological qualities of the instrument.
8.5 The instruments will not possess features that facilitate their fraudulent use and will be minimal the possibilities of incurring involuntary misuse. Components that must not be disassembled or adjusted by the user will be protected against such actions.
8.6 The instruments will be designed in such a way as to allow for the rapid implementation of the regulatory controls provided for in this Order.
9. Indication of the results of the weighing and other estimates of the weight. -indication of the results of the weighing and other estimates of the weight will be precise, clear and not to be misleading and the indicator device will allow an easy reading of the indication under normal conditions of use.
The names and symbols of the units mentioned in the number 1 of this Annex shall comply with the provisions of Royal Decree 1317/1989 of 27 October using the symbol "ct" for the metric carat.
The indication will not be possible above the maximum extent (Max) increased by 9 e.
Only one auxiliary indicator device is allowed to be installed behind the decimal mark. An extended indicator device can be temporarily used, but during operation, printing will not be possible.
Secondary indications may be shown, as long as they can be identified as such and are not confused with the primary indications.
10. Printing of the results of the weighing and other estimates of the weight. -The printed results will be correct, conveniently identifiable and unambiguously. The printing will be clear, legible, indelible and permanent.
11. Levelling.-Where appropriate, the instruments shall be equipped with a levelling device and a level indicator, of a sufficient sensitivity, to enable a suitable installation.
12. Set to zero. -The instruments may be equipped with devices to be set to zero. The operation of such devices will allow for accurate zero-to-zero and will not cause incorrect measurement results.
13. Tare device and tare predetermination devices. -Instruments may have one or more tare devices and a tare predetermination mechanism. The operation of the tare devices will produce a precise set to zero and will guarantee the correct net weights. The operation of the pre-determination device of the tare shall ensure the correct determination of the calculated net value.
14. Instruments for direct sale to the public with a maximum range not exceeding 100 kilograms. Additional conditions.-The instruments for direct sale to the public will clearly offer the customer all the essential information on the operation of the heavy goods and, in the case of instruments indicating the unit price, will indicate to the customer clearly the calculation of the amount of the item purchased.
The amount, if indicated, will be accurate.
Instruments that calculate the amount will have to present the essential indications for long enough for the customer to read them correctly.
These instruments may perform other functions in addition to the weighing and the calculation of the amount, provided that all indications relating to the transactions are clearly and unambiguously printed. reflected in a customer's intended label or label.
The instruments will not present features that may give, directly or indirectly, indications that cannot be interpreted easily or immediately.
The instruments will protect customers from improper sales transactions due to defective operation.
Auxiliary indicator devices and extended indicator devices will not be allowed.
Additional devices will only be allowed when they make fraudulent use impossible.
Instruments similar to those normally used for direct sale to the public, which do not meet the conditions required by this point, must bear the inscription "prohibited" in indelible form for direct sale to the public. "
15. Instruments for the labelling of the price or total amount. -Instruments for the labelling of the price or total amount shall comply with the applicable conditions laid down for the price indicators or the total amount in the instruments of Non-automatic weighing for direct sale to the public. Labels cannot be printed below the minimum range.
ANNEX II
Compliance check procedures
1. EC Model Approval.
1.1 The EC model approval is the procedure whereby a notified body checks and certifies that the representative instrument of production which is intended to be achieved complies with the applicable provisions of the this Order.
1.2 The application for model approval shall be submitted by the manufacturer or his authorised representative established in the European Union. For the same instrument, the application may be made before any notified body, at the choice of the manufacturer, and cannot be made, however, more than one of them. The application must include:
(a) The name and address of the manufacturer and, when presented by the authorised representative, also the name and address of the authorised representative.
b) A written statement that the application has not been filed with any other notified body.
(c) The technical documentation specified in Annex III.
The applicant shall make available to the notified body a representative instrument of what is intended to be produced, hereinafter referred to as "model".
1.3 The notified body.
1.3.1 You will examine the design documentation and verify that the model has been manufactured according to that documentation.
1.3.2 You will agree with the applicant where the exams or tests will be performed, or both.
1.3.3 shall carry out or carry out appropriate examinations or tests, or both, to confirm that the solutions adopted by the manufacturer meet the essential requirements, where the standards referred to in the Article 5 (2).
1.4 The notified body, after verifying that the model complies with the provisions of this Order, shall issue to the applicant an EC model approval certificate. The certificate shall include the conclusions of the examination, the conditions of its validity, if any, the data necessary for the identification of the approved instrument and the description of its operation. All descriptive elements of a technical nature, such as graphs or schemas, shall be attached as an annex to the EC model approval certificate.
1.5 Each notified body for the purposes of fulfilling its obligations to the Commission and to the other Member States shall provide the Administration with regular notification of:
a) The received model CE approval requests.
b) The model CE approval certificates issued.
c) Add-ons and modifications to documents already issued.
d) The deleted model CE approval certificates.
1.6 The applicant shall keep the body that issued the EC certificate of approval of the modifications made to the model informed.
When modifications made to an approved model affect conformity with the essential requirements of this Order or the prescribed conditions of use of the instrument, they must obtain approval of the model additional of the notified body which issued the EC model approval certificate. Such additional approval will be presented as an add-on to the original model CE approval certificate.
2. EC declaration of conformity with the model (guarantee of production quality).
2.1 The EC declaration of conformity with the model (production quality assurance) is the procedure whereby the manufacturer who fulfils the obligations referred to in paragraph 2.2 declares that the instruments are, in their case, conforming to the model described in the EC certificate of approval and meeting the applicable requirements of this Order.
The manufacturer or his authorised representative established within the European Union shall affix the CE marking to each instrument, as well as the inscriptions provided for in Annex IV, and shall extend a written declaration of conformity.
The CE marking shall be accompanied by the identification number of the notified body responsible for the EC control referred to in point 2.4.
2.2 The manufacturer shall apply an appropriate quality system in accordance with the provisions of paragraph 2.3 and shall be subject to the control specified in point 2.4.
2.3 Quality System.
2.3.1 The manufacturer shall submit the application for approval of the quality system to a notified body.
The request will include:
-a commitment to meet the obligations arising from the approved quality system;
-a commitment to maintain the approved quality system to ensure long-term efficiency.
The manufacturer shall make available to the notified body all the necessary information, in particular the documentation relating to the quality system and the design of the instrument.
2.3.2 The quality system ensures that the instruments conform to the model described in the EC model approval certificate and are in accordance with the requirements of this Order that affect them.
All elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic manner by means of written rules, instructions and procedures. Such quality system documentation shall ensure a common interpretation of quality programmes, plans, manuals and records.
The documentation will include an appropriate description of:
-the quality objectives, the organic structure, responsibilities and responsibilities of those responsible for the quality of the product;
-the manufacturing process, quality assurance and control techniques, processes and systematic operations performed;
-the examans and tests performed before during and after manufacture, and the frequency with which they are performed;
-the means to control the materialization of the quality of the product and the proper functioning of the quality control system.
2.3.3 The notified body shall examine and verify the quality system to determine whether it complies with the requirements of paragraph 2.3.2. Compliance with the provisions of that paragraph shall be presumed where the quality systems apply the relevant harmonised standards.
This body shall notify the manufacturer of its decision and inform the other notified bodies accordingly. The notification shall consist of the findings of the examination and, in the event of a refusal, a detailed justification for this decision.
2.3.4 The manufacturer or his legal representative shall inform the notified body that it has recognised its quality system for any updating of the quality assurance system, related to changes due, for example, to new technologies and quality concepts.
2.3.5 When a notified body withdraws its approval to a quality system, it must inform the Administration that it has notified it so that it, through the Secretariat of State for the European Communities, will notify the Commission, the other Member States and the relevant national and international organisations.
2.4 CE Control.
2.4.1 This is the procedure whereby the notified body concerned ensures that the manufacturer duly fulfils the obligations arising from the approved quality system.
2.4.2 The manufacturer shall allow the notified body the entry, for inspection purposes, to the places of manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:
-the documentation on the quality system;
-the technical documentation;
-quality records, such as inspection reports, test data, calibration data, staff fitness reports, etc.
The notified body shall carry out periodic audits in order to ensure that the manufacturer maintains and applies the quality system and shall provide a report on such audits to the manufacturer.
The notified body may visit the manufacturer without notice. During such visits, the notified body may carry out full or partial audits and provide the manufacturer with a report on the visit and, where appropriate, on the audit.
3. EC verification.
3.1 EC verification is the procedure by which the manufacturer or his authorised representative established in the European Union ensures and declares that the instruments complying with the provisions of point 3.3 are in conformity, where appropriate, to the model described in the model CE approval certificate and meet the relevant requirements of this Order.
3.2 The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures, where appropriate, the conformity of the instruments with the model described in the EC model approval certificate and with the relevant requirements of this Order. The manufacturer or his authorised representative established within the European Union shall affix the CE marking to each instrument and shall extend a written declaration of conformity.
3.3 The notified body shall carry out appropriate examinations and tests to verify the conformity of the instrument with the requirements of this Order by inspecting and testing each instrument as specified in the point 3.5.
3.4 In the case of instruments that are not subject to EC model approval, the notified body shall be able to access, on request, the documentation relating to the design of the instrument to which it refers. Annex III.
3.5 Verification through inspection and testing of each instrument.
3.5.1 The instruments shall be examined one by one and the appropriate tests as defined in the relevant standard or standards referred to in Article 5 (2) or equivalent tests shall be carried out to verify, where appropriate, its conformity with the model described in the EC model approval certificate and with the relevant requirements of this Order.
3.5.2 The notified body shall affix or cause its identification number to be placed on each instrument whose compliance with the requirements has been verified and shall extend a certificate of conformity concerning the tests. performed.
3.5.3 The manufacturer or his authorised representative established in the European Union must be able to present the notified body's certificates of conformity when requested.
4. CE verification per unit.
4.1 The EC verification per unit is the procedure by which the manufacturer or his authorised representative established in the European Union ensures and declares that the instrument, in general designed for a specific use and which it has obtained the certificate referred to in paragraph 4.2 meets the applicable requirements of this Order. The manufacturer or his authorised representative established in the European Union shall affix the CE marking to the instrument and extend a written declaration of conformity.
4.2 The notified body shall examine the instrument and carry out appropriate tests as defined in the applicable standard or rules referred to in Article 5 (2) and other equivalent tests to verify conformity. with the relevant requirements of this Order.
The notified body shall affix or cause its identification number to be placed on the instrument whose compliance with the essential requirements has been verified and shall extend a certificate of conformity relating to the tests performed.
4.3 The technical documentation relating to the design of the instrument and to which Annex III refers is intended to enable verification of compliance with the requirements of this Order, as well as the understanding of the design, the manufacture and operation of the instrument. Such documentation shall be made available to the notified body.
4.4 The manufacturer or his authorised representative established in the European Union must be able to present the notified body's certificates of conformity when requested.
5. Common provisions.
5.1 The EC declaration of conformity with the model (guarantee of production quality), EC verification and EC verification per unit may be carried out at the manufacturer's premises or elsewhere, provided that the following requirements are met in the latter case:
a) That the transport does not require disassembly of the instrument.
b) That their putting into service does not require the installation of the instrument and other technical interventions that may affect their performance.
c) That the value of the severity at the place of use was taken into account.
d) That the capabilities of the instrument are insensitive to variations of gravity.
In all other cases, the above procedures shall be carried out at the place where the instrument is to be used.
5.2 If the characteristics of the instrument are sensitive to variations in gravity, the procedures referred to in paragraph 5.1 may be performed in two phases:
(a) The first stage shall comprise all tests and tests which, not included in the second stage, can be carried out anywhere.
(b) The second stage shall comprise all tests and trials whose result depends on the gravity.
This second phase will be performed at the place of use of the instrument. In the case where areas of gravity have been established, the appropriate area of gravity shall be understood as the place of use of the instrument.
5.3.1 If a manufacturer has opted for two phases of one of the procedures mentioned in point 5.1 and two different teams are responsible for carrying out these two phases, the instrument that has been subject to the first stage of the procedure, the identification number of the notified body which has intervened in that stage shall be established.
5.3.2 The equipment which has carried out the first stage of the procedure shall, for each instrument, issue a written certificate showing the data necessary to identify the instrument, specifying the examinations and tests carried out.
The team performing the second phase of the procedure will perform the tests and tests that have not yet been performed.
The manufacturer or his authorised representative established in the European Union must be able to present the notified body's certificates of conformity when requested.
5.3.3 The manufacturer who has opted for the EC declaration of conformity with the model (production quality assurance) in the first stage may, in the second stage, either opt for the same procedure or for the verification EC.
5.3.4 The CE marking shall be affixed to the instrument after the end of the second stage, as shall the identification number of the notified body involved in the second stage.
ANNEX III
Technical documentation about the design
The technical documentation shall permit the clear interpretation of the design, manufacture, operation of the instrument and the verification of its conformity with the requirements of this Order.
The documentation will include:
-a general description of the model;
-design design, production diagrams and component projects, subsets, circuits, and so on;
-descriptions and explanations necessary for the understanding of the above, in particular the operation of the instrument;
-the rules referred to in Article 5 (2), applied in whole or in part, and descriptions of the solutions adopted to meet the essential requirements where the above standards have not been applied;
-the results of the design calculations and tests;
-the reports on the trials;
-EC model approval certificates and corresponding test results on instruments containing elements identical to those of the project.
ANNEX IV
Inscriptions and marking of instruments
1. Instruments subject to the EC conformity check procedure.
1.1 These instruments should take:
(a) the CE marking of conformity, which comprises the EC symbol described in Annex VI;
(b) the number or identification numbers of the notified body or notified bodies which have carried out the EC control or EC verification;
(c) a square vignette of at least 12,5 mm. of green colour, with the letter Mmayuscula as a black printing press.
d) the following entries:
-the number of the model CE approval certificate, if any;
-the name of the manufacturer;
-the precision class, within an oval or two horizontal lines joined by two semicircles;
-the maximum scope, in the form: Max. ...;
-the minimum scope, in the form: Min ...;
-the verification step, in the form: e = ...;
-the last two digits of the CE marking year.
In addition, where applicable, also the following entries:
-the manufacturing number;
-the identification mark on each element, for instruments consisting of separate but associated elements;
-the step if different from e, in the form: d = ...;
-the maximum additive effect of Tara, in the form: T = + ...;
-the maximum subtractive effect of tare, if different from Max in the form: T =-..;
-the tare step, if different from d, in the form: dt = ...;
-the limit load, if different from Max, in the form: Lim ...;
-the special temperature limits, in the form: orC/ ...orC;
-the relationship between weight and load receiver.
The CE conformity marking, the identification number of the notified body and the inscriptions mentioned above shall be attached to the instrument, grouped in a distinguishable manner.
1.2 The instruments must be equipped with appropriate areas in order to be able to affix the CE conformity marking, the identification number of the notified body or the aforementioned inscriptions. This shall be done so that they cannot be removed without being destroyed and that they are visible when the instrument is in a normal operating position.
1.3 When a nameplate is used, it will be sealable or sealed, unless it is impossible to remove without destroying it. If the plate is sealable, you will be able to apply a control mark.
1.4 Max, Min, and d inscriptions must also appear next to the result indication, if they do not appear in advance.
1.5 Any load measuring device that is or may be connected to one or more load receivers shall bear the appropriate inscriptions relating thereto.
2. Other instruments. -Other instruments shall bear:
-the name of the manufacturer;
-the maximum scope, in the form: Max ...
These instruments cannot carry the vignette referred to in paragraph 1.1.c) of this annex.
3. Restrictive symbol of use.-The restrictive symbol of use referred to in Article 10 of this Order shall be constituted by the letter M capital, in character of black printing on a red square background of at least 25 mm. two diagonals of the square.
ANNEX V
Notified Bodies
1. Minimum criteria for the recognition of a notified body.-In order for an agency to be recognised and officially designated to carry out the tasks relating to the procedures referred to in Article 5 (1), it shall comply with the following minimum requirements:
a) That you have the necessary personnel, equipment, and means to perform the activities for which you wish to be designated.
b) Your personnel are of recognized technical competence and professional integrity.
c) That the body and its personnel be independent from all circles, groups or persons, who have a direct or indirect interest in respect to the actions and surveillance required in this Order, in relation to the categories of instruments for which it is designated.
d) That your staff be warned that you must respect professional secrecy.
e) That the body has covered its civil liability through an insurance policy, if the insurance policy does not have public coverage.
Compliance with these requirements should be checked periodically.
2. Processing of recognition and notification. -The competent public administration, once the decision on the composition and resources of the notified body has been adopted, will inform the Spanish Metrology Center, providing the documentation next:
a) Composition of the body with indication of the units that constitute and support it, specifying both the competence and the administrative capacity to perform the metrological control, as well as the technical and organizational capacity of the laboratories that will do the tests.
(b) Metrological control activities to be carried out, indicating the specific categories of measuring instruments for which action and specification are intended for the modules for which they are requests to be notified in accordance with the provisions of the Decision of the Council of the European Communities 90 /683/EEC of 13 December.
(c) Technical procedures written under which laboratory tests of the metrological control activities shall be carried out, the recognition and notification of which is intended.
ANNEX VI
CE conformity marking
The CE conformity marking shall be composed of the initial CE designed as follows:
If the CE marking size is reduced or increased, the proportions of this logo should be retained.
The different elements of the CE marking shall have an appreciably equal vertical dimension which shall not be less than 5 mm.
