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Document 02014L0032-20150127
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 making available on the market of measuring instruments (recast) (Text with EEA relevance)
Consolidated text: 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 making available on the market of measuring instruments (recast) (Text with EEA relevance)
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 making available on the market of measuring instruments (recast) (Text with EEA relevance)
02014L0032 — EN — 27.01.2015 — 001.003
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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 making available on the market of measuring instruments (recast) (OJ L 096 29.3.2014, p. 149) |
Amended by:
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Official Journal |
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COMMISSION DELEGATED DIRECTIVE (EU) 2015/13 of 31 October 2014 |
L 3 |
42 |
7.1.2015 |
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Corrected by:
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 making available on the market of measuring instruments (recast)
(Text with EEA relevance)
CHAPTER 1
GENERAL PROVISIONS
Article 1
Subject matter
This Directive establishes the requirements that measuring instruments have to satisfy with a view to their being made available on the market and/or put into use for the measuring tasks referred to in Article 3(1).
Article 2
Scope
Article 3
Optionality
Article 4
Definitions
For the purposes of this Directive, the following definitions shall apply:
‘measuring instrument’ means any device or system with a measurement function that is covered by Article 2(1);
‘sub-assembly’ means a hardware device, mentioned as such in the instrument-specific annexes, that functions independently and makes up a measuring instrument together with other sub-assemblies with which it is compatible, or with a measuring instrument with which it is compatible;
‘legal metrological control’ means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading;
‘normative document’ means a document containing technical specifications adopted by the International Organisation of Legal Metrology;
‘making available on the market’ means any supply of a measuring instrument for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available of a measuring instrument on the Union market;
‘putting into use’ means the first use of a measuring instrument intended for the end-user for the purposes for which it was intended;
‘manufacturer’ means any natural or legal person who manufactures a measuring instrument or has a measuring instrument designed or manufactured, and markets that measuring instrument under his name or trade mark or puts it into use for his own purposes;
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
‘importer’ means any natural or legal person established within the Union who places a measuring instrument from a third country on the Union market;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a measuring instrument available on the market;
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a measuring instrument;
‘harmonised standard’ means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) no 765/2008;
‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) no 765/2008;
‘conformity assessment’ means the process demonstrating whether the essential requirements of this Directive relating to a measuring instrument have been fulfilled;
‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
‘recall’ means any measure aimed at achieving the return of a measuring instrument that has already been made available to the end-user;
‘withdrawal’ means any measure aimed at preventing a measuring instrument in the supply chain from being made available on the market;
‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
‘CE marking’ means a marking by which the manufacturer indicates that the measuring instrument is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.
Article 5
Applicability to sub-assemblies
Where instrument-specific annexes lay down the essential requirements for sub-assemblies, this Directive shall apply mutatis mutandis to such sub-assemblies.
Sub-assemblies and measuring instruments may be assessed independently and separately for the purpose of establishing conformity.
Article 6
Essential requirements
A measuring instrument shall meet the essential requirements set out in Annex I and in the relevant instrument-specific Annex.
Member States may require, if it is needed for correct use of the instrument, the information referred to in point 9 of Annex I or in the relevant instrument-specific Annexes to be provided in a language which can be easily understood by end-users, as determined by the Member State in which the instrument is made available on the market.
Article 7
Making available on the market and putting into use
When different accuracy classes are defined for a measuring instrument:
the instrument-specific Annexes under the heading ‘Putting into use’ may indicate the accuracy classes to be used for specific applications;
in all other cases a Member State may determine the accuracy classes to be used for specific applications within the classes defined, subject to allowing the use of all accuracy classes on its territory.
For the purposes of point (a) or point (b), measuring instruments of a better accuracy class may be used if the owner so chooses.
CHAPTER 2
OBLIGATIONS OF ECONOMIC OPERATORS
Article 8
Obligations of manufacturers
Where compliance of a measuring instrument with the applicable requirements of this Directive has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking and the supplementary metrology marking.
When deemed appropriate with regard to the performance of a measuring instrument, manufacturers shall carry out sample testing of measuring instruments made available on the market, investigate and, if necessary, keep a register of complaints, of non-conforming measuring instruments and measuring instrument recalls, and shall keep distributors informed of any such monitoring.
Article 9
Authorised representatives
The obligations laid down in Article 8(1) and the obligation to draw up technical documentation referred to in Article 8(2) shall not form part of the authorised representative’s mandate.
An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the measuring instrument has been placed on the market;
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a measuring instrument;
cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by measuring instruments covered by their mandate.
Article 10
Obligations of importers
Where an importer considers or has reason to believe that a measuring instrument is not in conformity with the essential requirements set out in Annex I and in the relevant instrument-specific Annexes, he shall not place the measuring instrument on the market or put it into use until it has been brought into conformity. Furthermore, where the measuring instrument presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
Article 11
Obligations of distributors
Where a distributor considers or has reason to believe that a measuring instrument is not in conformity with the essential requirements set out in Annex I and in the relevant instrument-specific Annexes, he shall not make the measuring instrument available on the market or put it into use, until it has been brought into conformity. Furthermore, where the measuring instrument presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
Article 12
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 8, where he places a measuring instrument on the market under his name or trade mark or modifies a measuring instrument already placed on the market in such a way that compliance with this Directive may be affected.
Article 13
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities:
any economic operator who has supplied them with a measuring instrument;
any economic operator to whom they have supplied a measuring instrument.
Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the measuring instrument and for 10 years after they have supplied the measuring instrument.
CHAPTER 3
CONFORMITY OF MEASURING INSTRUMENTS
Article 14
Presumption of conformity of measuring instruments
Article 15
Publication of the references of normative documents
On request by a Member State or in its own initiative, the Commission shall, where appropriate:
identify normative documents and, in a list, indicate the parts thereof that satisfy the requirements which they cover and which are set out in Annex I and in the relevant instrument-specific Annexes;
publish the reference of the normative documents and the list referred to in point (a) in the Official Journal of the European Union.
Article 16
Withdrawal of the references of normative documents
When a Member State or the Commission considers that a normative document whose reference has been published or is intended to be published in the Official Journal of the European Union does not entirely satisfy the essential requirements which it covers and which are set out in Annex I and in the relevant instrument-specific Annexes, the Commission shall decide:
to publish, not to publish or to publish with restriction the references to the normative documents concerned in the Official Journal of the European Union;
to maintain, to maintain with restrictions or to withdraw the references to the normative documents concerned in or from the Official Journal of the European Union.
Article 17
Conformity assessment procedures
Conformity assessment of a measuring instrument with the applicable essential requirements shall be carried out by the application, at the choice of the manufacturer, of one of the conformity assessment procedures listed in the relevant instrument-specific Annex.
The conformity assessment procedures are set out in Annex II.
Records and correspondence relating to conformity assessment procedures shall be drawn up in the official language(s) of the Member State where the notified body carrying out the conformity assessment procedures is established, or in a language accepted by that body.
Article 18
Technical documentation
The technical documentation shall be sufficiently detailed to ensure compliance with the following requirements:
the definition of the metrological characteristics;
the reproducibility of the metrological performances of produced measuring instruments when properly adjusted using appropriate intended means;
the integrity of the measuring instrument.
The technical documentation shall insofar as relevant for assessment and identification of the type and/or the measuring instrument include the following information:
a general description of the measuring instrument;
conceptual design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.;
manufacturing procedures to ensure consistent production;
if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;
descriptions and explanations necessary for the understanding of the information referred to in points (b), (c) and (d), including the operation of the measuring instrument;
a list of the harmonised standards and/or normative documents referred to in Article 14, applied in full or in part, the references of which have been published in the Official Journal of the European Union;
descriptions of the solutions adopted to meet the essential requirements where the harmonised standards and/or normative documents referred to in Article 14 have not been applied, including a list of other relevant technical specifications applied;
results of design calculations, examinations, etc.;
the appropriate test results, where necessary, to demonstrate that the type and/or the measuring instruments comply with the following:
the EU-type examination certificates or EU design examination certificates in respect of measuring instruments containing parts identical to those in the design.
Article 19
EU declaration of conformity
Article 20
Conformity marking
The conformity of a measuring instrument with this Directive shall be indicated by the presence on it of the CE marking and the supplementary metrology marking as specified in Article 21.
Article 21
General principles of the CE marking and of the supplementary metrology marking
Article 22
Rules and conditions for affixing the CE marking and the supplementary metrology marking
The CE marking and the supplementary metrology marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase as set out in Annex II.
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
The identification number of the notified body concerned shall be indelible or self destructive upon removal.
CHAPTER 4
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 23
Notification
Article 24
Notifying authorities
Article 25
Requirements relating to notifying authorities
Article 26
Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.
Article 27
Requirements relating to notified bodies
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of measuring instruments which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those measuring instruments, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
The second subparagraph does not, however, preclude the possibility of exchanges of technical information between the manufacturer and the body for the purposes of conformity assessment.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
At all times and for each conformity assessment procedure and each kind or category of measuring instruments in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the measuring instrument technology in question and the mass or serial nature of the production process.
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
The personnel responsible for carrying out conformity assessment tasks shall have the following:
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the essential requirements set out in Annex I and in the relevant instrument-specific Annexes, of the applicable harmonised standards and normative documents and of the relevant provisions of Union harmonisation legislation and of national legislation;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Article 28
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity 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, it shall be presumed to comply with the requirements set out in Article 27 in so far as the applicable harmonised standards cover those requirements.
Article 29
Subsidiaries of and subcontracting by notified bodies
Article 30
Accredited in-house bodies
An accredited in-house body shall meet the following requirements:
it shall be accredited in accordance with Regulation (EC) No 765/2008;
the body and its personnel shall be organisationally identifiable and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body;
neither the body nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the measuring instruments they assess nor shall they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities;
it shall supply its services exclusively to the undertaking of which it forms a part.
Article 31
Application for notification
Article 32
Notification procedure
Only such a body shall be considered a notified body for the purposes of this Directive.
Article 33
Identification numbers and lists of notified bodies
It shall assign a single such number even where the body is notified under several Union acts.
The Commission shall ensure that the list is kept up to date.
Article 34
Changes to notifications
Article 35
Challenge of the competence of notified bodies
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 46(2).
Article 36
Operational obligations of notified bodies
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the measuring instrument with this Directive.
Article 37
Appeal against decisions of notified bodies
Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.
Article 38
Information obligation on notified bodies
Notified bodies shall inform the notifying authority of the following:
any refusal, restriction, suspension or withdrawal of a certificate;
any circumstances affecting the scope of or conditions for notification;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Article 39
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.
Article 40
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral or cross sectoral group or groups of notified bodies.
Member States shall ensure that the bodies notified by them participate in the work of that group or those groups, directly or by means of designated representatives.
CHAPTER 5
UNION MARKET SURVEILLANCE, CONTROL OF MEASURING INSTRUMENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 41
Union market surveillance and control of measuring instruments entering the Union market
Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to measuring instruments.
Article 42
Procedure for dealing with measuring instruments presenting a risk at national level
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the measuring instrument does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the measuring instrument into compliance with those requirements, to withdraw the measuring instrument from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant measuring instrument, the origin of the measuring instrument, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:
failure of the measuring instrument to meet requirements relating to aspects of public interest protection laid down in this Directive; or
shortcomings in the harmonised standards or normative documents referred to in Article 14 conferring a presumption of conformity.
Article 43
Union safeguard procedure
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Article 44
Compliant measuring instruments which present a risk
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 46(3).
Article 45
Formal non-compliance
Without prejudice to Article 42, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
the CE marking or the supplementary metrology marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 22 of this Directive;
the CE marking or the supplementary metrology marking has not been affixed;
the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Article 22 or has not been affixed;
the EU declaration of conformity does not accompany the measuring instrument;
the EU declaration of conformity has not been drawn up correctly;
technical documentation is either not available or not complete.
the information referred to in Article 8(6) or Article 10(3) is absent, false or incomplete;
any other administrative requirement provided for in Article 8 or Article 10 is not fulfilled.
CHAPTER 6
COMMITTEE AND DELEGATED ACTS
Article 46
Committee procedure
The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
Article 47
Amendments of Annexes
The Commission shall be empowered to adopt delegated acts in accordance with Article 48 concerning the amendment of the instrument-specific Annexes, in relation to the following:
maximum permissible errors (MPEs) and accuracy classes;
rated operating conditions;
critical change values;
disturbances.
Article 48
Exercise of the delegation
CHAPTER 7
TRANSITIONAL AND FINAL PROVISIONS
Article 49
Penalties
Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules may include criminal penalties for serious infringements.
The penalties provided for shall be effective, proportionate and dissuasive.
Article 50
Transitional provisions
Certificates issued under Directive 2004/22/EC shall be valid under this Directive.
Article 51
Transposition
They shall apply those measures from 20 April 2016.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.
Article 52
Repeal
Without prejudice to Article 50, Directive 2004/22/EC as amended by the acts listed in Annex XIV, Part A, is repealed with effect from 20 April 2016 without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law and the dates of application of the Directives set out in Annex XIV, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XV.
Article 53
Entry into force and application
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Articles 1, 2 and 3, points 1 to 4 of Article 4, Articles 5, 6, 7, 15 to 18 and 20, Article 22(2) and (4) and Annexes I and III to XII shall apply from 20 April 2016.
Article 54
Addressees
This Directive is addressed to the Member States.
ANNEX I
ESSENTIAL REQUIREMENTS
A measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data.
The essential requirements that shall be met by measuring instruments are set out below and are supplemented, where appropriate, by specific instrument requirements in Annexes III to XII that provide more detail on certain aspects of the general requirements.
The solutions adopted in the pursuit of the essential requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof.
DEFINITIONS
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Measurand |
The measurand is the particular quantity subject to measurement. |
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Influence quantity |
An influence quantity is a quantity that is not the measurand but that affects the result of measurement. |
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Rated Operating Conditions |
The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument. |
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Disturbance |
An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified. |
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Critical change value |
The critical change value is the value at which the change in the measurement result is considered undesirable. |
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Material Measure |
A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity. |
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Direct sales |
A trading transaction is direct sales if: — the measurement result serves as the basis for the price to pay; and — at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection; and — all the parties in the transaction accept the measurement result at that time and place. |
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Climatic environments |
Climatic environments are the conditions in which measuring instruments may be used. To cope with climatic differences between the Member States, a range of temperature limits has been defined. |
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Utility |
A utility is regarded as a supplier of electricity, gas, thermal energy or water. |
ESSENTIAL REQUIREMENTS
1. Allowable Errors
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1.1. |
Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements. Unless stated otherwise in the instrument-specific annexes, MPE is expressed as a bilateral value of the deviation from the true measurement value. |
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1.2. |
Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements. Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE. |
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1.3. |
The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific annexes. 1.3.1. The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in the Annexes III to XII, and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.
Table 1
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1.4. |
When carrying out the tests as envisaged in this Directive, the following points shall apply: 1.4.1. Essential requirements specified in points 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific annex, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value. Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur. 1.4.2.
(a)
According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate.
(b)
The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate. |
2. Reproducibility
The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.
3. Repeatability
The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.
4. Discrimination and Sensitivity
A measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.
5. Durability
A measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer’s instruction when in the environmental conditions for which it is intended.
6. Reliability
A measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.
7. Suitability
7.1. A measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.
7.2. A measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.
7.3. The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased.
7.4. Where a measuring instrument is designed for the measurement of values of the measurand that are constant over time, the measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.
7.5. A measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.
7.6. A measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.
When a measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.
8. Protection against corruption
8.1. The metrological characteristics of a measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the measuring instrument.
8.2. A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.
8.3. Software that is critical for metrological characteristics shall be identified as such and shall be secured.
Software identification shall be easily provided by the measuring instrument.
Evidence of an intervention shall be available for a reasonable period of time.
8.4. Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.
8.5. For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use.
9. Information to be borne by and to accompany the instrument
9.1. A measuring instrument shall bear the following inscriptions:
manufacturer’s name, registered trade name or registered trade mark;
information in respect of its accuracy;
and, where applicable:
information in respect of the conditions of use;
measuring capacity;
measuring range;
identity marking;
number of the EU-type examination certificate or the EU design examination certificate;
information whether or not additional devices providing metrological results comply with the provisions of this Directive on legal metrological control.
9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of this Directive suitably marked.
9.3. The instrument shall be accompanied by information on its operation, unless the simplicity of the measuring instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant:
rated operating conditions;
mechanical and electromagnetic environment classes;
the upper and lower temperature limit, whether condensation is possible or not, open or closed location;
instructions for installation, maintenance, repairs, permissible adjustments;
instructions for correct operation and any special conditions of use;
conditions for compatibility with interfaces, sub-assemblies or measuring instruments.
9.4. Groups of identical measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals.
9.5. Unless specified otherwise in an instrument-specific annex, the scale interval for a measured value shall be in the form 1 × 10n, 2 × 10n, or 5 × 10n, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.
9.6. A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used.
9.7. The units of measurement used and their symbols shall be in accordance with the provisions of Union legislation on units of measurement and their symbols.
9.8. All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.
10. Indication of result
10.1. Indication of the result shall be by means of a display or hard copy.
10.2. The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.
10.3. In the case of hard copy the print or record shall also be easily legible and non-erasable.
10.4. A measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of this Directive shall bear appropriate restrictive information.
10.5. Whether or not a measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrologically controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay.
11. Further processing of data to conclude the trading transaction
11.1. A measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when:
the measurement is non-repeatable; and
the measuring instrument is normally intended for use in the absence of one of the trading parties.
11.2. Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.
12. Conformity evaluation
A measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of this Directive.
ANNEX II
MODULE A: INTERNAL PRODUCTION CONTROL
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1. |
‘Internal production control’ is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them. |
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2. |
Technical documentation
The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. |
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3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them. |
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4. |
Conformity marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive to each individual measuring instrument that satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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5. |
Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS
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1. |
Internal production control plus supervised instrument checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them. |
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2. |
Technical documentation
The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. |
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3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them. |
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4. |
Instrument checks
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the instrument, taking into account, inter alia, the technological complexity of the instruments and the quantity of production. An adequate sample of the final measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard, and/or normative document, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instruments with the relevant requirements of this Directive. In the absence of a relevant harmonised standard or normative document, the accredited in-house body or notified body concerned shall decide on the appropriate tests to be carried out. In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process. |
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5. |
Conformity marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive to each individual instrument that satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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6. |
Authorised representative
The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility provided that they are specified in the mandate. |
MODULE B: EU- TYPE EXAMINATION
1. ‘EU-type examination’ is the part of a conformity assessment procedure in which a notified body examines the technical design of an instrument and verifies and attests that the technical design of the instrument meets the requirements of this Directive that apply to it.
2. EU-type examination may be carried out in either of the following manners:
examination of a specimen, representative of the production envisaged, of the complete measuring instrument (production type),
assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type);
assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).
The notified body decides on the appropriate manner and the specimens required.
3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation as described in Article 18. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.
The application shall in addition contain, wherever applicable:
the specimens, representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme;
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards, and/or normative documents have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
4. The notified body shall:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument;
verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and normative documents, these have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards, and/or normative documents have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Directive;
agree with the manufacturer on the location where the examinations and tests will be carried out.
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the measuring instrument.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis, the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached.
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured measuring instruments with the examined type to be evaluated and to allow for in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include:
The EU-type examination certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
8. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the instrument with the essential requirements of this Directive or the conditions for validity of that certificate Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
9. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of that certificate.
10. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
11. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 8 and 10, provided that they are specified in the mandate.
MODULE C: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
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1. |
Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them. |
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2. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them. |
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3. |
Conformity marking and EU declaration of conformity
3.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive to each individual instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 3.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it was drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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4. |
Authorised representative
The manufacturer’s obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS
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1. |
Conformity to type based on internal production control plus supervised instrument checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them. |
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2. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them. |
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3. |
Instrument checks
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks on the instrument, taking into account, inter alia, the technological complexity of the measuring instruments and the quantity of production. An adequate sample of the final measuring instrument, taken on site by the accredited in-house body or by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant parts of the harmonised standards, and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instrument with the type described in the EU-type examination certificate and with the relevant requirements of this Directive. Where a sample does not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the instrument performs within acceptable limits, with a view to ensuring conformity of the instrument. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process. |
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4. |
Conformity marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking, and the supplementary metrology marking set out in this Directive to each individual measuring instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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5. |
Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
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1. |
Conformity to 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, and ensures and declares on his sole responsibility that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them. |
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2. |
Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 3 and shall be subject to surveillance as specified in point 4. |
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3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
(b)
a written declaration that the same application has not been lodged with any other notified body,
(c)
all relevant information for the instrument category envisaged;
(d)
the documentation concerning the quality system;
(e)
the technical documentation of the approved type and a copy of the EU-type examination certificate. 3.2. The quality system shall ensure that the measuring instruments are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
(b)
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(c)
the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;
(d)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
(e)
the means of monitoring the achievement of the required product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point (e) of point 3.1, to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
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4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
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5. |
Conformity marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual measuring instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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6. |
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a)
the documentation referred to in point 3.1,
(b)
the information relating to the change referred to in point 3.5, as approved;
(c)
the decisions and reports from the notified body referred to in points 3.5, 4.3 and 4.4. |
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7. |
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. |
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8. |
Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS
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1. |
Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them. |
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2. |
Technical documentation
The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. |
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3. |
The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market. |
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4. |
Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 5 and shall be subject to surveillance as specified in point 6. |
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5. |
Quality system
5.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
all relevant information for the instrument category envisaged;
(d)
the documentation concerning the quality system;
(e)
the technical documentation referred to in point 2. 5.2. The quality system shall ensure compliance of the measuring instruments with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
(b)
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(c)
the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;
(d)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
(e)
the means of monitoring the achievement of the required product quality and the effective operation of the quality system. 5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
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6. |
Surveillance under the responsibility of the notified body
6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the technical documentation referred to in point 2;
(c)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. 6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 6.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
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7. |
Conformity marking and EU declaration of conformity
7.1. The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual measuring instrument that satisfies the applicable requirements of this Directive. 7.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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8. |
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a)
the documentation referred to in point 5.1;
(b)
the information relating to the change referred to in point 5.5, as approved;
(c)
the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4. |
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9. |
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. |
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10. |
Authorised representative
The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE E: CONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE
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1. |
Conformity to type based on instrument quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the measuring instruments concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them. |
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2. |
Manufacturing
The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instruments concerned as specified in point 3 and shall be subject to surveillance, as specified in point 4. |
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3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the measuring instruments concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
all relevant information for the instrument category envisaged;
(d)
the documentation concerning the quality system;
(e)
the technical documentation of the approved type and a copy of the EU-type examination certificate. 3.2. The quality system shall ensure compliance of the measuring instruments with the type described in the EU-type examination certificate and with the applicable requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
(b)
the examinations and tests that will be carried out after manufacture;
(c)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
(d)
the means of monitoring the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point (e) of point 3.1, in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
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4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
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5. |
Conformity marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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6. |
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a)
the documentation referred to in point 3.1;
(b)
the information relating to the change referred to in point 3.5, as approved;
(c)
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. |
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7. |
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. |
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8. |
Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE E1: QUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING
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1. |
Quality assurance of final instrument inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them. |
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2. |
Technical documentation
The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. |
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3. |
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market. |
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4. |
Manufacturing
The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instruments concerned as specified in point 5 and shall be subject to surveillance as specified in point 6. |
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5. |
Quality system
5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the measuring instruments concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
all relevant information for the instrument category envisaged;
(d)
the documentation concerning the quality system;
(e)
the technical documentation referred to in point 2. 5.2. The quality system shall ensure compliance of the measuring instruments with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
(b)
the examinations and tests that will be carried out after manufacture;
(c)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
(d)
the means of monitoring the effective operation of the quality system. 5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
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6. |
Surveillance under the responsibility of the notified body
6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the technical documentation referred to in point 2;
(c)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. 6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 6.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
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7. |
Conformity marking and EU declaration of conformity
7.1. The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual measuring instrument that satisfies the applicable requirements of this Directive. 7.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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8. |
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a)
the documentation referred to in point 5.1,
(b)
the information relating to the change referred to in point 5.5, as approved;
(c)
the decisions and reports from the notified body referred to in points 5.5, 6.3 and 6.4. |
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9. |
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. |
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10. |
Authorised representative
The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
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1. |
Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on his sole responsibility that the measuring instruments concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them. |
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2. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them. |
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3. |
Verification
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the instruments with the type as described in the EU-type examination certificate and the appropriate requirements of this Directive. The examinations and tests to verify the conformity of the measuring instruments with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in point 4, or by examination and testing of the measuring instruments on a statistical basis as specified in point 5. |
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4. |
Verification of conformity by examination and testing of every instrument
4.1. All measuring instruments shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive. In the absence of a harmonised standard or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. 4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the instrument has been placed on the market. |
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5. |
Statistical verification of conformity
5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his measuring instruments for verification in the form of homogeneous lots. 5.2. A random sample shall be taken from each lot according to the requirements of point 5.3. All measuring instruments in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or normative document(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the type described in the EU-type examination certificate and with the applicable requirements of this Directive, and to determine whether the lot is accepted or rejected. In the absence of such harmonised standard or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. 5.3. The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure:
(a)
a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %;
(b)
a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %. 5.4. If a lot is accepted, all measuring instruments of the lot shall be considered approved, except for those measuring instruments from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market. 5.5. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. |
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6. |
Conformity marking and EU declaration of conformity
6.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual instrument that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 6.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. If y the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the measuring instruments. |
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7. |
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the measuring instruments during the manufacturing process. |
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8. |
Authorised 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 the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 2 and 5.1. |
MODULE F1: CONFORMITY BASED ON PRODUCT VERIFICATION
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1. |
Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the measuring instruments concerned which have been subject to the provisions of point 4, are in conformity with the requirements of this Directive that apply to them. |
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2. |
Technical documentation
The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market. |
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3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured measuring instruments with the applicable requirements of this Directive. |
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4. |
Verification
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the measuring instruments with the applicable requirements of this Directive. The examinations and tests to verify the conformity with the requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in point 5, or by examination and testing of the measuring instruments on a statistical basis as specified in point 6. |
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5. |
Verification of conformity by examination and testing of every instrument
5.1. All measuring instruments shall be individually examined and appropriate tests, set out in the relevant harmonized standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify their conformity with the requirements that apply to them. In the absence of such a harmonised standard, or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. 5.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market. |
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6. |
Statistical verification of conformity
6.1. The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of each lot produced, and shall present his measuring instruments for verification in the form of homogeneous lots. 6.2. A random sample shall be taken from each lot according to the requirements of point 6.4. 6.3. All measuring instruments in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of this Directive and to determine whether the lot is accepted or rejected. In the absence of such harmonised standard, or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. 6.4. The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure:
(a)
a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %;
(b)
a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %. 6.5. If a lot is accepted, all measuring instruments of the lot shall be considered approved, except for those measuring instruments from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market. If a lot is rejected, the notified body shall take appropriate measures to prevent that lot from being placed on the market. In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. |
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7. |
Conformity marking and EU declaration of conformity
7.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and under the responsibility of the notified body referred to in point 4, the latter’s identification number to each individual measuring instrument that satisfies the applicable requirements of this Directive. 7.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual measuring instruments in those cases where a large number of instruments is delivered to a single user. If the notified body referred to in point 5 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the measuring instruments. |
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8. |
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the measuring instruments during the manufacturing process. |
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9. |
Authorised 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 the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2, first paragraph, point 3 and point 6.1. |
MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
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1. |
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5 and ensures and declares on his sole responsibility that the instrument concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it. |
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2. |
Technical documentation
The manufacturer shall establish the technical documentation as described in Article 18 and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market. |
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3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instrument with the applicable requirements of this Directive. |
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4. |
Verification
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests set out in the relevant harmonised standards, and/or normative documents, or equivalent tests set out in other relevant technical specifications, to verify the conformity of the instrument with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard, or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and affix its identification number to the approved instrument, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market. |
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5. |
Conformity marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each instrument that satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with the measuring instrument. |
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6. |
Authorised representative
The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE
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1. |
Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them. |
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2. |
Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the measuring instruments concerned as specified in point 3, and shall be subject to surveillance as specified in point 4. |
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3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the measuring instruments concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
(b)
the technical documentation, as described in Article 18, for one model of each category of measuring instruments intended to be manufactured. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument,
(c)
the documentation concerning the quality system, and
(d)
a written declaration that the same application has not been lodged with any other notified body. 3.2. The quality system shall ensure compliance of the measuring instruments with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
(b)
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards, and/or normative documents will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the measuring instruments will be met applying other relevant technical specifications;
(c)
the design control and design verification techniques, processes and systematic actions that will be used when designing the measuring instruments pertaining to the instrument category covered;
(d)
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(e)
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
(f)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
(g)
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point (b) of point 3.1 to verify the manufacturer’s ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
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4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests.;
(c)
the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
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5. |
Conformity marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual instrument that satisfies the applicable requirements of this Directive. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
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6. |
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a)
the technical documentation referred to in point 3.1,
(b)
the documentation concerning the quality system referred to in point 3.1,
(c)
the information relating to the change referred to in point 3.5, as approved;
(d)
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. |
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7. |
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. |
|
8. |
Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
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1. |
Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this Directive that apply to them. |
|
2. |
Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the measuring instruments concerned as specified in point 3, and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the measuring instruments shall have been examined in accordance with point 4. |
|
3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of the quality system with the notified body of his choice for the measuring instruments concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)
all relevant information for the instrument category envisaged;
(c)
the documentation concerning the quality system;
(d)
a written declaration that the same application has not been lodged with any other notified body. 3.2. The quality system shall ensure compliance of the measuring instruments with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
(b)
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or normative documents will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the measuring instruments will be met, applying other relevant technical specifications;
(c)
the design control and design verification techniques, processes and systematic actions that will be used when designing the measuring instruments pertaining to the instrument category covered;
(d)
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(e)
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
(f)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
(g)
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer or his authorised representative of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 3.6. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. |
|
4. |
Design examination
4.1. The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1. 4.2. The application shall make it possible to understand the design, manufacture and operation of the instrument, and to assess the conformity with the requirements of this Directive that apply to it. It shall include:
(a)
the name and address of the manufacturer;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). It shall, as far as relevant for such assessment, cover the design and operation of the instrument;
(d)
the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or normative documents have not been applied in full, and shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications, by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. 4.3. The notified body shall examine the application, and where the design meets the requirements of this Directive that apply to the instrument it shall issue an EU design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached. That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured measuring instruments with the examined design to be evaluated and to allow for in-service control. It shall allow the evaluation of conformity of the manufactured instruments with the examined design regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, including:
(a)
the metrological characteristics of the design of the instrument;
(b)
measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.);
(c)
information on other elements necessary for the identification of the instrument and to check its visual external conformity to the design;
(d)
if appropriate, any specific information necessary to verify the characteristics of manufactured instruments;
(e)
in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments. The notified body shall establish an evaluation report in this regard and keep it at the disposal of the Member State that designated it. Without prejudice to Article 27(10), the notified body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. The certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each. Where the design does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 4.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval – from the notified body that issued the EU design examination certificate – in the form of an addition to the original EU design examination certificate. 4.5. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate. 4.6. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions with the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market. |
|
5. |
Surveillance under the responsibility of the notified body
5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 5.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
(c)
the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. 5.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 5.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
|
6. |
Conformity marking and EU declaration of conformity
6.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual instrument that satisfies the applicable requirements of this Directive. 6.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up and shall mention the number of the design examination certificate. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. |
|
7. |
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a)
the documentation concerning the quality system referred to in point 3.1,
(b)
the information relating to the change referred to in point 3.5, as approved;
(c)
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4. |
|
8. |
Authorised representative
The manufacturer’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate. |
ANNEX III
WATER METERS (MI-001)
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to water meters intended for the measurement of volumes of clean, cold or heated water in residential, commercial and light industrial use.
DEFINITIONS
|
Water Meter |
An instrument designed to measure, memorise and display the volume at metering conditions of water passing through the measurement transducer. |
|
Minimum Flowrate (Q1) |
The lowest flowrate at which the water meter provides indications that satisfy the requirements concerning the maximum permissible errors (MPEs.) |
|
Transitional Flowrate (Q2) |
The transitional flowrate is the flowrate value occurring between the permanent and minimum flowrates, at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘lower zone’. Each zone has a characteristic MPE. |
|
Permanent Flowrate (Q3) |
The highest flowrate at which the water meter operates in a satisfactory manner under normal conditions of use, i.e. under steady or intermittent flow conditions. |
|
Overload Flowrate (Q4) |
The overload flowrate is the highest flowrate at which the meter operates in a satisfactory manner for a short period of time without deteriorating. |
SPECIFIC REQUIREMENTS
Rated Operating Conditions
The manufacturer shall specify the rated operating conditions for the instrument, in particular:
The flowrate range of the water.
The values for the flowrate range shall fulfil the following conditions:
The temperature range of the water.
The values for the temperature range shall fulfil the following conditions:
The meter may be designed to operate over both ranges.
The relative pressure range of the water, the range being 0,3 bar to at least 10 bar at Q3.
For the power supply: the nominal value of the AC voltage supply and/or the limits of DC supply.
MPE
5. The MPE, positive or negative, on volumes delivered at flowrates between the transitional flowrate (Q2) (included) and the overload flowrate (Q4) is:
The meter shall not exploit the MPE or systematically favour any party.
6. The MPE, positive or negative, on volumes delivered at flowrates between the minimum flowrate (Q1) and the transitional flowrate (Q2) (excluded) is 5 % for water having any temperature.
The meter shall not exploit the MPE or systematically favour any party.
Permissible Effect of Disturbances
7.1. Electromagnetic immunity
7.1.1. The effect of an electromagnetic disturbance on a water meter shall be such that:
7.1.2. After undergoing an electromagnetic disturbance the water meter shall:
7.1.3. The critical change value is the smaller of the two following values:
7.2. Durability
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:
The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed:
The error of indication for the volume metered after the durability test shall not exceed:
Suitability
8.1. The meter shall be able to be installed to operate in any position unless clearly marked otherwise.
8.2. The manufacturer shall specify whether the meter is designed to measure reverse flow. In such a case, the reverse flow volume shall either be subtracted from the cumulated volume or shall be separately recorded. The same MPE shall apply to both forward and reverse flow.
Water meters not designed to measure reverse flow shall either prevent reverse flow or shall withstand an accidental reverse flow without any deterioration or change in metrological properties.
Units of Measurement
9. Metered volume shall be displayed in cubic metres.
Putting into Use
10. The Member State shall ensure that the requirements under points 1, 2 and 3 are determined by the utility or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
B + F or B + D or H1.
ANNEX IV
GAS METERS AND VOLUME CONVERSION DEVICES (MI-002)
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to gas meters and volume conversion devices defined below, intended for residential, commercial and light industrial use.
DEFINITIONS
|
Gas meter |
An instrument designed to measure, memorise and display the quantity of fuel gas (volume or mass) that has passed it. |
|
Conversion device |
A device fitted to a gas meter that automatically converts the quantity measured at metering conditions into a quantity at base conditions. |
|
Minimum flowrate (Qmin) |
The lowest flowrate at which the gas meter provides indications that satisfy the requirements regarding maximum permissible error (MPE). |
|
Maximum flowrate (Qmax) |
The highest flowrate at which the gas meter provides indications that satisfy the requirements regarding MPE. |
|
Transitional flowrate (Qt) |
The transitional flowrate is the flowrate occurring between the maximum and minimum flowrates at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘lower zone’. Each zone has a characteristic MPE. |
|
Overload Flowrate (Qr) |
The overload flowrate is the highest flowrate at which the meter operates for a short period of time without deteriorating. |
|
Base conditions |
The specified conditions to which the measured quantity of fluid is converted. |
PART I
SPECIFIC REQUIREMENTS
GAS METERS
1. Rated operating conditions
The manufacturer shall specify the rated operating conditions of the gas meter, taking into account:
|
1.1. |
The flowrate range of the gas shall fulfil at least the following conditions:
|
|
1.2. |
The temperature range of the gas, with a minimum range of 40 °C. |
|
1.3. |
The fuel/gas related conditions
The gas meter shall be designed for the range of gases and supply pressures of the country of destination. In particular the manufacturer shall indicate:
—
the gas family or group;
—
the maximum operating pressure.
|
|
1.4. |
A minimum temperature range of 50 °C for the climatic environment. |
|
1.5. |
The nominal value of the AC voltage supply and/or the limits of DC supply. |
2. Maximum permissible error (MPEs)
2.1. Gas meter indicating the volume at metering conditions or mass
Table 1
|
Class |
1,5 |
1,0 |
|
Qmin ≤ Q < Qt |
3 % |
2 % |
|
Qt ≤ Q ≤ Qmax |
1,5 % |
1 % |
The gas meter shall not exploit the MPEs or systematically favour any party.
|
2.2. |
For a gas meter with temperature conversion, which only indicates the converted volume, the MPE of the meter is increased by 0,5 % in a range of 30 °C extending symmetrically around the temperature specified by the manufacturer that lies between 15 °C and 25 °C. Outside this range, an additional increase of 0,5 % is permitted in each interval of 10 °C. |
3. Permissible effect of disturbances
3.1. Electromagnetic immunity
3.1.1. The effect of an electromagnetic disturbance on a gas meter or volume conversion device shall be such that:
3.1.2. After undergoing a disturbance, the gas meter shall:
3.1.3. The critical change value is the smaller of the two following values:
3.2. Effect of upstream-downstream flow disturbances
Under installation conditions specified by the manufacturer, the effect of the flow disturbances shall not exceed one third of the MPE.
4. Durability
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:
4.1. Class 1,5 meters
4.1.1. The variation of the measurement result after the durability test when compared with the initial measurement result for the flow rates in the range Qt to Qmax- shall not exceed the measurement result by more than 2 %.
4.1.2. The error of indication after the durability test shall not exceed twice the MPE in point 2.
4.2. Class 1,0 meters
4.2.1. The variation of the measurement result after the durability test when compared with the initial measurement result shall not exceed one-third of the MPE in point 2.
4.2.2. The error of indication after the durability test shall not exceed the MPE in point 2.
5. Suitability
5.1. A gas meter powered from the mains (AC or DC) shall be provided with an emergency power supply device or other means to ensure, during a failure of the principal power source, that all measuring functions are safeguarded.
5.2. A dedicated power source shall have a lifetime of at least five years. After 90 % of its lifetime an appropriate warning shall be shown.
5.3. An indicating device shall have a sufficient number of digits to ensure that the quantity passed during 8 000 hours at Qmax does not return the digits to their initial values.
5.4. The gas meter shall be able to be installed to operate in any position declared by the manufacturer in its installation instruction.
5.5. The gas meter shall have a test element, which shall enable tests to be carried out in a reasonable time.
5.6. The gas meter shall respect the MPE in any flow direction or only in one flow direction clearly marked.
6. Units
Metered quantity shall be displayed in cubic metre, or in kilogram.
PART II
SPECIFIC REQUIREMENTS
VOLUME CONVERSION DEVICES
A volume conversion device constitutes a sub-assembly when it is together with a measuring instrument with which it is compatible.
For a volume conversion device, the essential requirements for the gas meter shall apply, if applicable. In addition, the following requirements shall apply:
7. Base conditions for converted quantities
The manufacturer shall specify the base conditions for converted quantities.
8. MPE
Note:
The error of the gas meter is not taken into account.
The volume conversion device shall not exploit the MPEs or systematically favour any party.
9. Suitability
9.1. An electronic conversion device shall be capable of detecting when it is operating outside the operating range(s) stated by the manufacturer for parameters that are relevant for measurement accuracy. In such a case, the conversion device must stop integrating the converted quantity, and may totalise separately the converted quantity for the time it is operating outside the operating range(s).
9.2. An electronic conversion device shall be capable to display all relevant data for the measurement without additional equipment.
PART III
PUTTING INTO USE AND CONFORMITY ASSESSMENT
Putting into use
10.
Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class 1,5 meter, and by Class 1,0 meters which have a Qmax/Qmin ratio equal or greater than 150.
Where a Member State imposes measurement of commercial and/or light industrial use, it shall allow such measurement to be performed by any Class 1,5 meter.
As regards the requirements under points 1.2 and 1.3, Member States shall ensure that the properties be determined by the utility or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are
B + F or B + D or H1.
ANNEX V
ACTIVE ELECTRICAL ENERGY METERS (MI-003)
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to active electrical energy meters intended for residential, commercial and light industrial use.
Note:
Electrical energy meters may be used in combination with external instrument transformers, depending upon the measurement technique applied. However, this Annex covers only electrical energy meters but not instrument transformers.
DEFINITIONS
An active electrical energy meter is a device which measures the active electrical energy consumed in a circuit.
|
I |
= |
the electrical current flowing through the meter; |
|
In |
= |
the specified reference current for which the transformer operated meter has been designed; |
|
Ist |
= |
the lowest declared value of I at which the meter registers active electrical energy at unity power factor (polyphase meters with balanced load); |
|
Imin |
= |
the value of I above which the error lies within maximum permissible errors (MPEs) (polyphase meters with balanced load); |
|
Itr |
= |
the value of I above which the error lies within the smallest MPE corresponding to the class index of the meter; |
|
Imax |
= |
the maximum value of I for which the error lies within the MPEs; |
|
U |
= |
the voltage of the electricity supplied to the meter; |
|
Un |
= |
the specified reference voltage; |
|
f |
= |
the frequency of the voltage supplied to the meter; |
|
fn |
= |
the specified reference frequency; |
|
PF |
= |
power factor = cosφ = the cosine of the phase difference φ between I and U. |
SPECIFIC REQUIREMENTS
1. Accuracy
The manufacturer shall specify the class index of the meter. The class indices are defined as: Class A, B and C.
2. Rated operating conditions
The manufacturer shall specify the rated operating conditions of the meter; in particular:
The values of fn, Un, In, Ist, Imin, Itr and Imax that apply to the meter. For the current values specified, the meter shall satisfy the conditions given in Table 1;
Table 1
|
|
Class A |
Class B |
Class C |
|
For direct-connected meters |
|||
|
Ist |
|
|
|
|
Imin |
|
|
|
|
Imax |
|
|
|
|
For transformer-operated meters |
|||
|
Ist |
|
|
|
|
Imin |
|
|
|
|
In |
|
|
|
|
Imax |
|
|
|
|
(1) For Class B electromechanical meters
|
|||
The voltage, frequency and power factor ranges within which the meter shall satisfy the MPE requirements are specified in Table 2. These ranges shall recognise the typical characteristics of electricity supplied by public distribution systems.
The voltage and frequency ranges shall be at least:
power factor range at least from cosφ = 0,5 inductive to cosφ = 0,8 capacitive.
3. MPEs
The effects of the various measurands and influence quantities (a, b, c,…) are evaluated separately, all other measurands and influence quantities being kept relatively constant at their reference values. The error of measurement, that shall not exceed the MPE stated in Table 2, is calculated as:
When the meter is operating under varying-load current, the percentage errors shall not exceed the limits given in Table 2.
Table 2
|
MPEs in percent at rated operating conditions and defined load current levels and operating temperature |
||||||||||||
|
|
Operating temperatures |
Operating temperatures |
Operating temperatures |
Operating temperatures |
||||||||
|
|
+ 5 °C … + 30 °C |
– 10 °C … + 5 °C or + 30 °C … + 40 °C |
– 25 °C … – 10 °C or + 40 °C … + 55 °C |
– 40 °C … – 25 °C or + 55 °C … + 70 °C |
||||||||
|
Meter class |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
|
Single phase meter; polyphase meter if operating with balanced loads |
||||||||||||
|
|
3,5 |
2 |
1 |
5 |
2,5 |
1,3 |
7 |
3,5 |
1,7 |
9 |
4 |
2 |
|
|
3,5 |
2 |
0,7 |
4,5 |
2,5 |
1 |
7 |
3,5 |
1,3 |
9 |
4 |
1,5 |
|
Polyphase meter if operating with single phase load |
||||||||||||
|
|
4 |
2,5 |
1 |
5 |
3 |
1,3 |
7 |
4 |
1,7 |
9 |
4,5 |
2 |
| For electromechanical polyphase meters the current range for single-phase load is limited to
|
||||||||||||
When a meter operates in different temperature ranges the relevant MPE values shall apply.
The meter shall not exploit the MPEs or systematically favour any party.
4. Permissible effect of disturbances
4.1. General
As electrical energy meters are directly connected to the mains supply and as mains current is also one of the measurands, a special electromagnetic environment is used for electricity meters.
The meter shall comply with the electromagnetic environment E2 and the additional requirements in points 4.2 and 4.3.
The electromagnetic environment and permissible effects reflect the situation that there are disturbances of long duration which shall not affect the accuracy beyond the critical change values and transient disturbances, which may cause a temporary degradation or loss of function or performance but from which the meter shall recover and shall not affect the accuracy beyond the critical change values.
When there is a foreseeable high risk due to lightning or where overhead supply networks are predominant, the metrological characteristics of the meter shall be protected.
4.2. Effect of disturbances of long duration
Table 3
|
Critical change values for disturbances of long duration |
|||
|
Disturbance |
Critical change values in percent for meters of class |
||
|
A |
B |
C |
|
|
Reversed phase sequence |
1,5 |
1,5 |
0,3 |
|
Voltage unbalance (only applicable to polyphase meters) |
4 |
2 |
1 |
|
Harmonic contents in the current circuits (1) |
1 |
0,8 |
0,5 |
|
DC and harmonics in the current circuit (1) |
6 |
3 |
1,5 |
|
Fast transient bursts |
6 |
4 |
2 |
|
Magnetic fields; HF (radiated RF) electromagnetic field; Conducted disturbances introduced by radio-frequency fields; and Oscillatory waves immunity |
3 |
2 |
1 |
|
(1)
In the case of electromechanical electricity meters, no critical change values are defined for harmonic contents in the current circuits and for DC and harmonics in the current circuit. |
|||
4.3. Permissible effect of transient electromagnetic phenomena
4.3.1. The effect of an electromagnetic disturbance on an electrical energy meter shall be such that during and immediately after a disturbance:
and in reasonable time after the disturbance the meter shall:
(m being the number of measuring elements of the meter, Un in Volts and Imax in Amps).
4.3.2. For overcurrent the critical change value is 1,5 %.
5. Suitability
|
5.1. |
Below the rated operating voltage the positive error of the meter shall not exceed 10 %. |
|
5.2. |
The display of the total energy shall have a sufficient number of digits to ensure that when the meter is operated for 4 000 hours at full load (I = Imax, U = Un and PF = 1) the indication does not return to its initial value and shall not be able to be reset during use. |
|
5.3. |
In the event of loss of electricity in the circuit, the amounts of electrical energy measured shall remain available for reading during a period of at least 4 months. |
|
5.4. |
Running with no load
When the voltage is applied with no current flowing in the current circuit (current circuit shall be open circuit), the meter shall not register energy at any voltage between |
and 1,1 U|
5.5. |
Starting
The meter shall start and continue to register at Un, PF = 1 (polyphase meter with balanced loads) and a current which is equal to Ist. |
6. Units
The electrical energy measured shall be displayed in kilowatt-hours or in megawatt-hours.
7. Putting into use
(a) Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class A meter. For specified purposes the Member State is authorised to require any Class B meter.
(b) Where a Member State imposes measurement of commercial and/or light industrial use, it shall allow such measurement to be performed by any Class B meter. For specified purposes the Member State is authorised to require any Class C meter.
(c) The Member State shall ensure that the current range be determined by the utility or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
B + F or B + D or H1.
ANNEX VI
THERMAL ENERGY METERS (MI-004)
The relevant requirements of Annex I, the specific requirements and the conformity assessment procedures listed in this Annex, apply to thermal energy meters defined below, intended for residential, commercial and light industrial use.
DEFINITIONS
A thermal energy meter is an instrument designed to measure the thermal energy which, in a thermal energy exchange circuit, is given up by a liquid called the thermal energy-conveying liquid.
A thermal energy meter is either a complete instrument or a combined instrument consisting of the sub-assemblies, flow sensor, temperature sensor pair, and calculator, as defined in Article 4(2), or a combination thereof
|
θ |
= |
the temperature of the thermal energy-conveying liquid; |
|
θin |
= |
the value of θ at the inlet of the thermal energy exchange circuit; |
|
θοut |
= |
the value of θ at the outlet of the thermal energy exchange circuit; |
|
Δθ |
= |
the temperature difference θin — θοut with Δθ ≥ 0; |
|
θmax |
= |
the upper limit of θ for the thermal energy meter to function correctly within the MPEs; |
|
θmin |
= |
the lower limit of θ for the thermal energy meter to function correctly within the MPEs; |
|
Δθmax |
= |
the upper limit of Δθ for the thermal energy meter to function correctly within the MPEs; |
|
Δθmin |
= |
the lower limit of Δθ for the thermal energy meter to function correctly within the MPEs; |
|
q |
= |
the flow rate of the thermal energy conveying liquid; |
|
qs |
= |
the highest value of q that is permitted for short periods of time for the thermal energy meter to function correctly; |
|
qp |
= |
the highest value of q that is permitted permanently for the thermal energy meter to function correctly; |
|
qi |
= |
the lowest value of q that is permitted for the thermal energy meter to function correctly; |
|
P |
= |
the thermal power of the thermal energy exchange; |
|
Ps |
= |
the upper limit of P that is permitted for the thermal energy meter to function correctly. |
SPECIFIC REQUIREMENTS
1. Rated operating conditions
The values of the rated operating conditions shall be specified by the manufacturer as follows:
For the temperature of the liquid: θmax, θmin,
subject to the following restrictions:
; Δθmin = 3 K or 5 K or 10 K.
For the pressure of the liquid: The maximum positive internal pressure that the thermal energy meter can withstand permanently at the upper limit of the temperature.
For the flow rates of the liquid: qs, qp, qi, where the values of qp and qi are subject to the following restriction:
.
For the thermal power: Ps.
2. Accuracy classes
The following accuracy classes are defined for thermal energy meters: 1, 2, 3.
3. MPEs applicable to complete thermal energy meters
The maximum permissible relative errors applicable to a complete thermal energy meter, expressed in percent of the true value for each accuracy class, are:
The complete thermal energy meter shall not exploit the MPEs or systematically favour any party.
4. Permissible influences of electromagnetic disturbances
4.1. The instrument shall not be influenced by static magnetic fields and by electromagnetic fields at mains frequency.
4.2. The influence of an electromagnetic disturbance shall be such that the change in the measurement result is not greater than the critical change value as laid down in requirement 4.3 or the indication of the measurement result is such that it cannot be interpreted as a valid result.
4.3. The critical change value for a complete thermal energy meter is equal to the absolute value of the MPE applicable to that thermal energy meter (see point (3).
5. Durability
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:
Flow sensors: The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed the critical change value.
Temperature sensors: The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed 0,1 °C.
6. Inscriptions on a thermal energy meter
7. Sub-assemblies
The provisions for sub-assemblies may apply to sub-assemblies manufactured by the same or different manufacturers. Where a thermal energy meter consists of sub-assemblies, the essential requirements for the thermal energy meter apply to the sub-assemblies as relevant. In addition, the following apply:
|
7.1. |
The relative MPE of the flow sensor, expressed in %, for accuracy classes:
—
Class 1:
—
Class 2:
—
Class 3:
where the error Ef relates the indicated value to the true value of the relationship between flow sensor output signal and the mass or the volume. |
|
7.2. |
The relative MPE of the temperature sensor pair, expressed in %:
—
where the error Et relates the indicated value to the true value of the relationship between temperature sensor pair output and temperature difference. |
|
7.3. |
The relative MPE of the calculator, expressed in %:
—
where the error Ec relates the value of the thermal energy indicated to the true value of the thermal energy. |
|
7.4. |
The critical change value for a sub-assembly of a thermal energy meter is equal to the respective absolute value of the MPE applicable to the sub-assembly (see points 7.1, 7.2 or 7.3). |
|
7.5. |
Inscriptions on the sub-assemblies
|
PUTTING INTO USE
|
8. |
(a)
Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class 3 meter.
(b)
Where a Member State imposes measurement of commercial and/or light industrial use, it is authorised to require any Class 2 meter.
(c)
As regards the requirements under points 1.1 to 1.4, Member States shall ensure that the properties be determined by the utility or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable. |
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
B + F or B + D or H1.
ANNEX VII
MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES OF LIQUIDS OTHER THAN WATER (MI-005)
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to measuring systems intended for the continuous and dynamic measurement of quantities (volumes or masses) of liquids other than water. If appropriate, the terms ‘volume, and L’ in this Annex can be read as: ‘mass and kg’.
DEFINITIONS
|
Meter |
An instrument designed to measure continuously, memorise and display the quantity at metering conditions of liquid flowing through the measurement transducer in a closed, fully charged conduit. |
|
Calculator |
A part of a meter that receives the output signals from the measurement transducer(s) and possibly, from associated measuring instruments and displays the measurement results. |
|
Associated measuring instrument |
An instrument connected to the calculator for measuring certain quantities which are characteristic of the liquid, with a view to make a correction and/or conversion. |
|
Conversion Device |
A part of the calculator which by taking account of the characteristics of the liquid (temperature, density, etc.) measured using associated measuring instruments, or stored in a memory, automatically converts: — the volume of the liquid measured at metering conditions into a volume at base conditions and/or into mass, or — the mass of the liquid measured at metering conditions into a volume at metering conditions and/or into a volume at base conditions Note: A conversion device includes the relevant associated measuring instruments. |
|
Base conditions |
The specified conditions to which the measured quantity of liquid at metering conditions is converted. |
|
Measuring System |
A system that comprises the meter itself and all devices required to ensure correct measurement or intended to facilitate the measuring operations. |
|
Fuel dispenser |
A measuring system intended for the refuelling of motor vehicles, small boats and small aircraft. |
|
Self-service arrangement |
An arrangement that allows the customer to use a measuring system for the purpose of obtaining liquid for his own use. |
|
Self-service device |
A specific device that is part of a self-service arrangement and which allows one of more measuring systems to perform in this self-service arrangement. |
|
Minimum measured quantity (MMQ) |
The smallest quantity of liquid for which the measurement is metrologically acceptable for the measuring system. |
|
Direct indication |
The indication, either volume or mass, corresponding to the measure and that the meter is physically capable of measuring. Note: The direct indication may be converted into another quantity using a conversion device. |
|
Interruptible/non-interruptible |
A measuring system is considered as interruptible/non-interruptible when the liquid flow can/cannot be stopped easily and rapidly. |
|
Flowrate range |
The range between the minimum flowrate (Qmin) and maximum flowrate (Qmax). |
SPECIFIC REQUIREMENTS
1. Rated operating conditions
The manufacturer shall specify the rated operating conditions for the instrument, in particular;
1.1. The flowrate range
The flowrate range is subject to the following conditions:
the flowrate range of a measuring system shall be within the flowrate range of each of its elements, in particular the meter.
meter and measuring system:
Table 1
|
Specific measuring system |
Characteristic of liquid |
Minimum ratio of Qmax: Qmin |
|
Fuel dispensers |
Not Liquefied gases |
10: 1 |
|
Liquefied gases |
5: 1 |
|
|
Measuring system |
Cryogenic liquids |
5: 1 |
|
Measuring systems on pipeline and systems for loading ships |
All liquids |
Suitable for use |
|
All other measuring systems |
All liquids |
4: 1 |
|
1.2. |
The properties of the liquid to be measured by the instrument by specifying the name or type of the liquid or its relevant characteristics, for example:
—
Temperature range;
—
Pressure range;
—
Density range;
—
Viscosity range.
|
|
1.3. |
The nominal value of the AC voltage supply and/or limits of the DC voltage supply. |
|
1.4. |
The base conditions for converted values. Note: Point 1.4 is without prejudice to the Member States’ obligations to require use of a temperature of either 15 °C in accordance with Article 12(2) of Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity ( 11 ). |
2. Accuracy classification and maximum permissible errors (MPEs)
|
2.1. |
For quantities equal to or greater than 2 litres the MPE on indications is:
Table 2
|
||||||||||||||||||||||||
|
2.2. |
For quantities less than two litres the MPE on indications is:
Table 3
|
|
2.3. |
However, no matter what the measured quantity may be, the magnitude of the MPE is given by the greater of the following two values:
—
the absolute value of the MPE given in Table 2 or Table 3,
—
the absolute value of the MPE for the minimum measured quantity (Emin).
|
|
2.4.1. |
For minimum measured quantities greater than or equal to 2 litres the following conditions apply: Condition 1
Emin shall fulfil the condition: Emin ≥ 2 R, where R is the smallest scale interval of the indication device.
Condition 2
Emin is given by the formula:
—
MMQ is the minimum measured quantity,
—
A is the numerical value specified in line A of Table 2.
|
|
2.4.2. |
For minimum measured quantities of less than two litres, the above mentioned condition 1 applies and Emin is twice the value specified in Table 3, and related to line A of Table 2. |
|
2.5. |
Converted indication
In the case of a converted indication the MPEs are as in line A of Table 2. |
|
2.6. |
Conversion devices
MPEs on converted indications due to a conversion device are equal to ± (A — B), A and B being the values specified in Table 2. Parts of conversion devices that can be tested separately (a) MPEs on quantities of liquid indications applicable to calculation, positive or negative, are equal to one-tenth of the MPEs as defined in line A of Table 2. (b) Associated measuring instruments shall have an accuracy at least as good as the values in Table 4:
Table 4
These values apply to the indication of the characteristic quantities of the liquid displayed by the conversion device. (c) The MPE for the calculation of each characteristic quantity of the liquid, positive or negative, is equal to two fifths of the value fixed in (b). |
|||||||||||||||||||||||||||||
|
2.7. |
The requirement (a) in point 2.6 applies to any calculation, not only conversion. |
|
2.8. |
The measuring system shall not exploit the MPEs or systematically favour any party. |
3. Maximum permissible effect of disturbances
3.1. The effect of an electromagnetic disturbance on a measuring system shall be one of the following:
3.2. The critical change value is the greater of MPE/5 for a particular measured quantity or Emin.
4. Durability
After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criterion shall be satisfied:
The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed the value for meters specified in line B of table 2.
5. Suitability
|
5.1. |
For any measured quantity relating to the same measurement, the indications provided by various devices shall not deviate one from another by more than one scale interval where devices have the same scale interval. In the case where the devices have different scale intervals, the deviation shall not be more than that of the greatest scale interval. However, in the case of a self-service arrangement the scale intervals of the main indicating device on the measuring system and the scale intervals of the self-service device shall be the same and results of measurement shall not deviate one from another. |
|
5.2. |
It shall not be possible to divert the measured quantity in normal conditions of use unless it is readily apparent. |
|
5.3. |
Any percentage of air or gas not easily detectable in the liquid shall not lead to a variation of error greater than:
—
0,5 % for liquids other than potable liquids and for liquids of a viscosity not exceeding 1 mPa.s, or
—
1 % for potable liquids and for liquids of a viscosity exceeding 1 mPa.s.
However, the allowed variation shall never be smaller than 1 % of MMQ. This value applies in the case of air or gas pockets. |
|
5.4. |
Instruments for direct sales
|
|
5.5. |
Fuel Dispensers
|
6. Power supply failure
A measuring system shall either be provided with an emergency power supply device that will safeguard all measuring functions during the failure of the main power supply device or be equipped with means to save and display the data present in order to permit the conclusion of the transaction in progress and with means to stop the flow at the moment of the failure of the main power supply device.
7. Putting into use
Table 5
|
Accuracy Class |
Types of Measuring system |
|
0,3 |
Measuring systems on pipeline |
|
0,5 |
All measuring systems if not differently stated elsewhere in this Table, in particular: — fuel dispensers (not for liquefied gases), — measuring systems on road tankers for liquids of low viscosity (< 20 mPa.s) — measuring systems for (un)loading ships and rail and road tankers (1) — measuring systems for milk — measuring systems for refuelling aircraft |
|
1,0 |
Measuring systems for liquefied gases under pressure measured at a temperature equal to or above – 10 °C |
|
Measuring systems normally in class 0,3 or 0,5 but used for liquids — whose temperature is less than – 10 °C or greater than 50 °C — whose dynamic viscosity is higher than 1 000 mPa.s — whose maximum volumetric flowrate is not higher than 20 L/h |
|
|
1,5 |
Measuring systems for liquefied carbon dioxide |
|
Measuring systems for liquefied gases under pressure measured at a temperature below – 10 °C (other than cryogenic liquids) |
|
|
2,5 |
measuring systems for cryogenic liquids (temperature below – 153 °C) |
|
(1)
However, Member States may require measuring systems of accuracy class 0,3 or 0,5 when used for the levying of duties on mineral oils when (un)loading ships and rail and road tankers. Note: However, the manufacturer may specify a better accuracy for a certain type of measuring system. |
|
8. Units of measurement
The metered quantity shall be displayed in millilitres, cubic centimetres, litres, cubic metres, grams, kilograms or tonnes.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
B + F or B + D or H1 or G.
ANNEX VIII
AUTOMATIC WEIGHING INSTRUMENTS (MI-006)
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in Chapter I of this Annex, apply to automatic weighing instruments defined below, intended to determine the mass of a body by using the action of gravity on that body.
DEFINITIONS
|
Automatic weighing instrument |
An instrument that determines the mass of a product without the intervention of an operator and follows a predetermined programme of automatic processes characteristic of the instrument. |
|
Automatic catchweigher |
An automatic weighing instrument that determines the mass of pre-assembled discrete loads (for example prepackages) or single loads of loose material. |
|
Automatic checkweigher |
An automatic catchweigher that subdivides articles of different mass into two or more subgroups according to the value of the difference of their mass and a nominal set-point. |
|
Weight labeller |
An automatic catchweigher that labels individual articles with the weight value. |
|
Weight/price labeller |
An automatic catchweigher that labels individual articles with the weight value, and price information. |
|
Automatic gravimetric filling instrument |
An automatic weighing instrument that fills containers with a predetermined and virtually constant mass of product from bulk. |
|
Discontinuous totaliser (totalising hopper weigher) |
An automatic weighing instrument that determines the mass of a bulk product by dividing it into discrete loads. The mass of each discrete load is determined in sequence and summed. Each discrete load is then delivered to bulk. |
|
Continuous totaliser |
An automatic weighing instrument that continuously determines the mass of a bulk product on a conveyor belt, without systematic subdivision of the product and without interrupting the movement of the conveyor belt. |
|
Rail-weighbridge |
An automatic weighing instrument having a load receptor inclusive of rails for conveying railway vehicles. |
SPECIFIC REQUIREMENTS
CHAPTER I
Requirements common to all types of automatic weighing instruments
1. Rated Operating Conditions
The manufacturer shall specify the rated operating conditions for the instrument as follows:
For the measurand:
The measuring range in terms of its maximum and minimum capacity.
For the electrical supply influence quantities:
|
In case of AC voltage supply |
: |
the nominal AC voltage supply, or the AC voltage limits. |
|
In case of DC voltage supply |
: |
the nominal and minimum DC voltage supply, or the DC voltage limits. |
For the mechanical and climatic influence quantities:
The minimum temperature range is 30 °C unless specified otherwise in the following chapters of this Annex.
The mechanical environment classes according to Annex I, point 1.3.2 are not applicable. For instruments which are used under special mechanical strain, e.g. instruments incorporated into vehicles, the manufacturer shall define the mechanical conditions of use.
For other influence quantities (if applicable):
2. Permissible effect of disturbances — Electromagnetic environment
The required performance and the critical change value are given in the relevant Chapter of this Annex for each type of instrument.
3. Suitability
3.1. Means shall be provided to limit the effects of tilt, loading and rate of operation such that maximum permissible errors (MPEs) are not exceeded in normal operation.
3.2. Adequate material handling facilities shall be provided to enable the instrument to respect the MPEs during normal operation.
3.3. Any operator control interface shall be clear and effective.
3.4. The integrity of the display (where present) shall be verifiable by the operator.
3.5. Adequate zero setting capability shall be provided to enable the instrument to respect the MPEs during normal operation.
3.6. Any result outside the measurement range shall be identified as such, where a printout is possible.
4. Conformity assessment
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
CHAPTER II
Automatic Catchweighers
1. Accuracy Classes
1.1. Instruments are divided into primary categories designated by:
X or Y
as specified by the manufacturer.
1.2. These primary categories are further divided into four accuracy classes:
which shall be specified by the manufacturer.
2. Category X Instruments
2.1. Category X applies to instruments used to check prepackages made up in accordance with the requirements of Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products ( 12 ) applicable to prepackages.
2.2. The accuracy classes are supplemented by a factor (x) that quantifies the maximum permissible standard deviation as specified in point 4.2.
The manufacturer shall specify the factor (x), where (x) shall be ≤ 2 and in the form 1 × 10k, 2 × 10k or 5 × 10k, where k is a negative whole number or zero.
3. Category Y Instruments
Category Y applies to all other automatic catchweighers.
4. MPE
4.1. Mean error Category X/MPE Category Y instruments
Table 1
|
Net Load (m) in verification scale intervals (e) |
Maximum permissible mean error |
Maximum permissible error |
|||||||
|
XI |
Y(I) |
XII |
Y(II) |
XIII |
Y(a) |
XIIII |
Y(b) |
X |
Y |
|
0 < m ≤ 50 000 |
0 < m ≤ 5 000 |
0 < m ≤ 500 |
0 < m ≤ 50 |
± 0,5 e |
± 1 e |
||||
|
50 000 < m ≤ 200 000 |
5 000 < m ≤ 20 000 |
500 < m ≤ 2 000 |
50 < m ≤ 200 |
± 1,0 e |
± 1,5 e |
||||
|
200 000 < m |
20 000 < m ≤ 100 000 |
2 000 < m ≤ 10 000 |
200 < m ≤ 1 000 |
± 1,5 e |
± 2 e |
||||
4.2. Standard deviation
Maximum permissible value for the standard deviation of a class X (x) instrument is the result of the multiplication of the factor (x) by the value in Table 2 below.
Table 2
|
Net Load (m) |
Maximum permissible standard deviation for class X(1) |
|
m ≤ 50 g |
0,48 % |
|
50 g < m ≤ 100 g |
0,24 g |
|
100 g < m ≤ 200 g |
0,24 % |
|
200 g < m ≤ 300 g |
0,48 g |
|
300 g < m ≤ 500 g |
0,16 % |
|
500 g < m ≤ 1 000 g |
0,8 g |
|
1 000 g < m ≤ 10 000 g |
0,08 % |
|
10 000 g < m ≤ 15 000 g |
8 g |
|
15 000 g < m |
0,053 % |
For class XI and XII (x) shall be less than 1.
For class XIII (x) shall be not greater than 1.
For class XIIII (x) shall be greater than 1.
4.3. Verification scale interval — single interval instruments
Table 3
|
Accuracy classes |
Verification scale interval |
Number of verification scale intervals
|
||
|
|
|
|
Minimum |
Maximum |
|
XI |
Y(I) |
0,001 g ≤ e |
50 000 |
— |
|
XII |
Y(II) |
0,001 g ≤ e ≤ 0,05 g |
100 |
100 000 |
|
0,1 g ≤ e |
5 000 |
100 000 |
||
|
XIII |
Y(a) |
0,1 g ≤ e ≤ 2 g |
100 |
10 000 |
|
5 g ≤ e |
500 |
10 000 |
||
|
XIIII |
Y(b) |
5 g ≤ e |
100 |
1 000 |
4.4. Verification scale interval — multi-interval instruments
Table 4
|
Accuracy classes |
Verification scale interval |
Number of verification scale intervals
|
||
|
|
|
|
Minimum value (1)
|
Maximum value
|
|
XI |
Y(I) |
0,001 g ≤ ei |
50 000 |
— |
|
XII |
Y(II) |
0,001 g ≤ ei ≤ 0,05 g |
5 000 |
100 000 |
|
|
|
0,1 g ≤ ei |
5 000 |
100 000 |
|
XIII |
Y(a) |
0,1 g ≤ ei |
500 |
10 000 |
|
XIIII |
Y(b) |
5 g ≤ ei |
50 |
1 000 |
|
(1)
For i = r the corresponding column of Table 3 applies with e replaced by er. |
||||
Where:
|
i |
= |
1, 2, … r |
|
i |
= |
partial weighing range |
|
r |
= |
total number of partial ranges |
5. Measurement Range
In specifying the measurement range for class Y instruments the manufacturer shall take account that the minimum capacity shall not be less than:
|
class Y(I) |
: |
100 e |
|
class Y(II) |
: |
20 e for 0,001 g ≤ e ≤ 0,05 g, and 50 e for 0,1 g ≤ e |
|
class Y(a) |
: |
20 e |
|
class Y(b) |
: |
10 e |
|
Scales used for grading, e.g. postal scales and garbage weighers |
: |
5 e |
6. Dynamic Setting
6.1. The dynamic setting facility shall operate within a load range specified by the manufacturer.
6.2. When fitted, a dynamic setting facility that compensates for the dynamic effects of the load in motion shall be inhibited from operating outside the load range, and shall be capable of being secured.
7. Performance Under Influence Factors And Electromagnetic Disturbances
|
7.1. |
The MPEs due to influence factors are:
|
|
7.2. |
The critical change value due to a disturbance is one verification scale interval. |
|
7.3. |
Temperature range:
—
For class XI and Y(I) the minimum range is 5 °C,
—
For class XII and Y(II) the minimum range is 15 °C.
|
CHAPTER III
Automatic Gravimetric Filling Instruments
1. Accuracy classes
1.1. The manufacturer shall specify both the reference accuracy class Ref(x) and the operational accuracy class(es) X(x).
1.2. An instrument type is designated a reference accuracy class, Ref(x), corresponding to the best possible accuracy for instruments of the type. After installation, individual instruments are designated for one or more operational accuracy classes, X(x), having taken account of the specific products to be weighed. The class designation factor (x) shall be ≤ 2, and in the form 1 × 10k, 2 × 10k or 5 × 10k where k is a negative whole number or zero.
1.3. The reference accuracy class, Ref(x) is applicable for static loads.
1.4. For the operational accuracy class X(x), X is a regime relating accuracy to load weight and (x) is a multiplier for the limits of error specified for class X(1) in point 2.2.
2. MPE
2.1. Static weighing error
2.1.1. For static loads under rated operating conditions, the MPE for reference accuracy class Ref(x), shall be 0,312 of the maximum permissible deviation of each fill from the average; as specified in Table 5; multiplied by the class designation factor (x).
2.1.2. For instruments where the fill may be made up from more than one load (e.g. cumulative or selective combination weighers) the MPE for static loads shall be the accuracy required for the fill as specified in point 2.2 (i.e. not the sum of the maximum permissible deviation for the individual loads).
2.2. Deviation from average fill
Table 5
|
Value of the mass, m (g), of the fills |
Maximum permissible deviation of each fill from the average for class X(1) |
|
m ≤ 50 |
7,2 % |
|
50 < m ≤ 100 |
3,6 g |
|
100 < m ≤ 200 |
3,6 % |
|
200 < m ≤ 300 |
7,2 g |
|
300 < m ≤ 500 |
2,4 % |
|
500 < m ≤ 1 000 |
12 g |
|
1 000 < m ≤ 10 000 |
1,2 % |
|
10 000 < m ≤ 15 000 |
120 g |
|
15 000 < m |
0,8 % |
Note:
The calculated deviation of each fill from the average may be adjusted to take account for the effect of material particle size.
2.3. Error relative to pre-set value (setting error)
For instruments where it is possible to pre-set a fill weight; the maximum difference between the pre-set value and the average mass of the fills shall not exceed 0,312 of the maximum permissible deviation of each fill from the average, as specified in Table 5.
3. Performance Under Influence Factor And Electromagnetic Disturbance
3.1. The MPE due to influence factors shall be as specified in point 2.1.
3.2. The critical change value due to a disturbance is a change of the static weight indication equal to the MPE as specified in point 2.1 calculated for the rated minimum fill, or a change that would give equivalent effect on the fill in the case of instruments where the fill consists of multiple loads. The calculated critical change value shall be rounded to the next higher scale interval (d).
3.3. The manufacturer shall specify the value of the rated minimum fill.
CHAPTER IV
Discontinuous Totalisers
1. Accuracy Classes
Instruments are divided into four accuracy classes as follows: 0,2; 0,5; 1; 2.
2. MPEs
Table 6
|
Accuracy class |
MPE of totalised load |
|
0,2 |
± 0,10 % |
|
0,5 |
± 0,25 % |
|
1 |
± 0,50 % |
|
2 |
± 1,00 % |
3. Totalisation scale interval
The totalisation scale interval (dt) shall be in the range:
0,01 % Max ≤ dt ≤ 0,2 % Max
4. Minimum Totalised Load (Σmin)
The minimum totalised load (Σmin) shall be not less than the load at which the MPE is equal to the totalisation scale interval (dt) and not less than the minimum load as specified by the manufacturer.
5. Zero Setting
Instruments that do not tare weigh after each discharge shall have a zero setting device. Automatic operation shall be inhibited if zero indication varies by:
6. Operator Interface
Operator adjustments and reset function shall be inhibited during automatic operation.
7. Printout
On instruments equipped with a printing device, the reset of the total shall be inhibited until the total is printed. The printout of the total shall occur if automatic operation is interrupted.
8. Performance under influence factors and electromagnetic disturbances
8.1. The MPEs due to influence factors shall be as specified in Table 7.
Table 7
|
Load (m) in totalisation scale intervals (dt) |
MPE |
|
0 < m ≤ 500 |
± 0,5 dt |
|
500 < m ≤ 2 000 |
± 1,0 dt |
|
2 000 < m ≤ 10 000 |
± 1,5 dt |
8.2. The critical change value due to a disturbance is one totalisation scale interval for any weight indication and any stored total.
CHAPTER V
Continuous Totalisers
1. Accuracy classes
Instruments are divided into three accuracy classes as follows: 0,5; 1; 2.
2. Measurement Range
2.1. The manufacturer shall specify the measurement range, the ratio between the minimum net load on the weighing unit and the maximum capacity, and the minimum totalised load.
2.2. The minimum totalised load Σmin shall not be less than
Where d is the totalisation scale interval of the general totalisation device.
3. MPE
Table 8
|
Accuracy class |
MPE for totalised load |
|
0,5 |
± 0,25 % |
|
1 |
± 0,5 % |
|
2 |
± 1,0 % |
4. Speed of the belt
The speed of the belt shall be specified by the manufacturer. For single-speed beltweighers, and variable-speed beltweighers having a manual speed setting control, the speed shall not vary by more than 5 % of the nominal value. The product shall not have a different speed than the speed of the belt.
5. General Totalisation Device
It shall not be possible to reset the general totalisation device to zero.
6. Performance under influence factors and electromagnetic disturbances
6.1. The MPE due to influence factor, for a load not less than the Σmin, shall be 0,7 times the appropriate value specified in Table 8, rounded to the nearest totalisation scale interval (d).
6.2. The critical change value due to a disturbance shall be 0,7 times the appropriate value specified in Table 8, for a load equal to Σmin, for the designated class of the beltweigher; rounded up to the next higher totalisation scale interval (d).
CHAPTER VI
Automatic Rail Weighbridges
1. Accuracy classes
Instruments are divided into four accuracy classes as follows:
0,2; 0,5; 1; 2.
2. MPE
2.1. The MPEs for weighing-in-motion of a single wagon or a total train are shown in Table 9.
Table 9
|
Accuracy class |
MPE |
|
0,2 |
± 0,1 % |
|
0,5 |
± 0,25 % |
|
1 |
± 0,5 % |
|
2 |
± 1,0 % |
2.2. The MPEs for the weight of coupled or uncoupled wagons weighing-in-motion shall be one of the following values, whichever is the greatest:
2.3. The MPEs for the weight of train weighing-in-motion shall be one of the following values, whichever is the greatest:
2.4. When weighing coupled wagons; the errors of not more than 10 % of the weighing results taken from one or more passes of the train may exceed the appropriate MPE given in point 2.2, but shall not exceed twice the MPE.
3. Scale interval (d)
The relationship between the accuracy class and the scale interval shall be as specified in Table 10.
Table 10
|
Accuracy class |
Scale interval (d) |
|
0,2 |
d ≤ 50 kg |
|
0,5 |
d ≤ 100 kg |
|
1 |
d ≤ 200 kg |
|
2 |
d ≤ 500 kg |
4. Measurement range
4.1. The minimum capacity shall not be less than 1 t, and not greater than the value of the result of the minimum wagon weight divided by the number of partial weighings.
4.2. The minimum wagon weight shall not be less than 50 d.
5. Performance under influence factor and electromagnetic disturbance
5.1. The MPE due to an influence factor shall be as specified in Table 11.
Table 11
|
Load (m) in verification scale intervals (d) |
MPE |
|
0 < m ≤ 500 |
± 0,5 d |
|
500 < 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 one scale interval.
ANNEX IX
TAXIMETERS (MI-007)
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex apply to taximeters.
DEFINITIONS
Taximeter
A device that works together with a signal generator ( 13 ) to make a measuring instrument.
This device measures duration, calculates distance on the basis of a signal delivered by the distance signal generator. Additionally, it calculates and displays the fare to be paid for a trip on the basis of the calculated distance and/or the measured duration of the trip.
Fare
The total amount of money due for a trip based on a fixed initial hire fee and/or the length and/or the duration of the trip. The fare does not include a supplement charged for extra services.
Cross-over speed
The speed value found by division of a time tariff value by a distance tariff value.
Normal calculation mode S (single application of tariff)
Fare calculation based on application of the time tariff below the cross-over speed and application of the distance tariff above the cross-over speed.
Normal calculation mode D (double application of tariff)
Fare calculation based on simultaneous application of time tariff and distance tariff over the whole trip.
Operating position
The different modes in which a taximeter fulfils the different parts of its functioning. The operating positions are distinguished by the following indications:
|
‘For Hire’ |
: |
The operating position in which the fare calculation is disabled |
|
‘Hired’ |
: |
The operating position in which the fare calculation takes place on the basis of a possible initial charge and a tariff for distance travelled and/or time of the trip |
|
‘Stopped’ |
: |
The operating position in which the fare due for the trip is indicated and at least the fare calculation based on time is disabled. |
DESIGN REQUIREMENTS
1. The taximeter shall be designed to calculate the distance and to measure the duration of a trip.
2. The taximeter shall be designed to calculate and display the fare, incrementing in steps equal to the resolution fixed by the Member State in the operation position ‘Hired’. The taximeter shall also be designed to display the final value for the trip in the operating position ‘Stopped’.
3. A taximeter shall be able to apply the normal calculation modes S and D. It shall be possible to choose between these calculation modes by a secured setting.
4. A taximeter shall be able to supply the following data through an appropriate secured interface(s):
National legislation may require certain devices to be connected to the interface(s) of a taximeter. Where such a device is required; it shall be possible, by secured setting, to inhibit automatically the operation of the taximeter for reasons of the non-presence or improper functioning of the required device.
5. If relevant, it shall be possible to adjust a taximeter for the constant of the distance signal generator to which it is to be connected and to secure the adjustment.
RATED OPERATING CONDITIONS
6.1. The mechanical environment class that applies is M3.
6.2. The manufacturer shall specify the rated operating conditions for the instrument, in particular:
MAXIMUM PERMISSIBLE ERRORS (MPEs)
7. The MPE, excluding any errors due to application of the taximeter in a taxi, are:
PERMISSIBLE EFFECT OF DISTURBANCES
8. Electromagnetic immunity
8.1. The electromagnetic class that applies is E3.
8.2. The MPE laid down in point 7 shall also be respected in the presence of an electromagnetic disturbance.
POWER SUPPLY FAILURE
9. In case of a reduction of the voltage supply to a value below the lower operating limit as specified by the manufacturer, the taximeter shall:
OTHER REQUIREMENTS
10. The conditions for the compatibility between the taximeter and the distance signal generator shall be specified by the manufacturer of the taximeter.
11. If there is a supplement charge for an extra service, entered by the driver on manual command, this shall be excluded from the fare displayed. However, in that case a taximeter may display temporarily the value of the fare including the supplementary charge.
12. If the fare is calculated according to calculation mode D a taximeter may have an additional display mode in which only the total distance and duration of the trip are displayed in real time.
13. All values displayed for the passenger shall be suitably identified. These values as well as their identification shall be clearly readable under daylight and night conditions.
14.1. If the fare to be paid or the measures to be taken against fraudulent use can be affected by the choice of functionality from a pre-programmed setting or by free data setting, it shall be possible to secure the instrument settings and data entered.
14.2. The securing possibilities available in a taximeter shall be such that separate securing of the settings is possible.
14.3. The provisions in point 8.3 of Annex I apply also to the tariffs.
15.1. A taximeter shall be fitted with non-resettable totalisers for all of the following values:
The totalised values shall include the values saved according to point 9 under conditions of loss of power supply.
15.2. If disconnected from power, a taximeter shall allow the totalised values to be stored for one year for the purpose of reading out the values from the taximeter to another medium.
15.3. Adequate measures shall be taken to prevent the display of totalised values from being used to deceive passengers.
16. Automatic change of tariffs is allowed due to the:
17. If properties of the taxi are important for the correctness of the taximeter, the taximeter shall provide means to secure the connection of the taximeter to the taxi in which it is installed.
18. For the purpose of testing after installation, the taximeter shall be equipped with the possibility to test separately the accuracy of time and distance measurement and the accuracy of the calculation.
19. A taximeter and its installation instructions specified by the manufacturer shall be such that, if installed according to the manufacturer’s instructions, fraudulent alterations of the measurement signal representing the distance travelled are sufficiently excluded.
20. The general essential requirement dealing with fraudulent use shall be fulfilled in such a way that the interests of the customer, the driver, the driver’s employer and the fiscal authorities are protected.
21. A taximeter shall be designed so that it can respect the MPEs without adjustment during a period of one year of normal use.
22. The taximeter shall be equipped with a real-timeclock by means of which the time of the day and the date are kept, one or both can be used for automatic change of tariffs. The requirements for the real-time clock are:
23. The values of distance travelled and time elapsed, when displayed or printed in accordance with this Directive, shall use the following units:
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
B + F or B + D or H1.
ANNEX X
MATERIAL MEASURES (MI-008)
CHAPTER I
Material measures of length
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this chapter, apply to material measures of length defined below. However, the requirement for the supply of a copy of declarations of conformity may be interpreted as applying to a batch or consignment rather than each individual instrument.
DEFINITIONS
|
Material measure of length |
An instrument comprising scale marks whose distances are given in legal units of length. |
SPECIFIC REQUIREMENTS
Reference Conditions
1.1. For tapes of length equal to or greater than 5 metres, the maximum permissible errors (MPEs) are to be met when a tractive force of fifty newtons or other force values as specified by the manufacturer and marked on the tape accordingly, or in the case of rigid or semi-rigid measures no tractive force is needed, is applied.
1.2. The reference temperature is 20 °C unless otherwise specified by the manufacturer and marked on the measure accordingly.
MPEs
2. The MPE, positive or negative in mm, between two non-consecutive scale marks is (a + bL), where:
When a terminal interval is bounded by a surface, the MPE for any distance beginning at this point is increased by the value c given in Table 1.
Table 1
|
Accuracy Class |
a (mm) |
b |
c (mm) |
|
I |
0,1 |
0,1 |
0,1 |
|
II |
0,3 |
0,2 |
0,2 |
|
III |
0,6 |
0,4 |
0,3 |
|
D — special class for dipping tapes (1) Up to and including 30 m (2) |
1,5 |
zero |
zero |
|
S — special class for tank strapping tapes For each 30 m length when the tape is supported on a flat surface |
1,5 |
zero |
zero |
|
(1)
Applies to the tape/dip weight combinations.
(2)
If the nominal tape length exceeds 30 m, an additional mpe of 0,75 mm shall be permitted for each 30 m of tape length. |
|||
Dip tapes may also be of Classes I or II in which case for any length between two scale marks, one of which is on the sinker and the other on the tape, the MPE is ± 0,6 mm when application of the formula gives a value of less than 0,6 mm.
The MPE for the length between consecutive scale marks, and the maximum permissible difference between two consecutive intervals, are given in Table 2 below.
Table 2
|
Length i of the interval |
MPE or difference in millimetres according to accuracy class |
||
|
I |
II |
III |
|
|
i ≤ 1 mm |
0,1 |
0,2 |
0,3 |
|
1 mm < i ≤ 1 cm |
0,2 |
0,4 |
0,6 |
Where a rule is of the folding type, the jointing shall be such as not to cause any errors, supplementary to those above, exceeding: 0,3 mm for Class II, and 0,5 mm for Class III.
Materials
3.1. Materials used for material measures shall be such that length variations due to temperature excursions up to ± 8 °C about the reference temperature do not exceed the MPE. This does not apply to Class S and Class D measures where the manufacturer intends that thermal expansion corrections shall be applied to observed readings where necessary.
3.2. Measures made from material whose dimensions may alter materially when subjected to a wide range of relative humidity, may only be included in Classes II or III.
Markings
4. The nominal value shall be marked on the measure. Millimetre scales shall be numbered every centimetre and measures with a scale interval greater than 2 cm shall have all scale marks numbered.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
F 1 or D1 or B + D or H or G.
CHAPTER II
Capacity serving measures
The relevant essential requirements of Annex I, and the specific requirements and the conformity assessment procedures listed in this chapter, apply to capacity serving measures defined below. However, the requirement for the supply of a copy of declarations of conformity may be interpreted as applying to a batch or consignment rather than each individual instrument. Also, the requirement for the instrument to bear information in respect of its accuracy shall not apply.
DEFINITIONS
|
Capacity serving measure |
A capacity measure (such as a drinking glass, jug or thimble measure) designed to determine a specified volume of a liquid (other than a pharmaceutical product) which is sold for immediate consumption. |
|
Line measure |
A capacity serving measure marked with a line to indicate nominal capacity. |
|
Brim measure |
A capacity serving measure for which the internal volume is equal to the nominal capacity. |
|
Transfer measure |
A capacity serving measure from which it is intended that the liquid is decanted prior to consumption. |
|
Capacity |
The capacity is the internal volume for brim measures or internal volume to a filling mark for line measures. |
SPECIFIC REQUIREMENTS
1. Reference Conditions
1.1. Temperature: the reference temperature for measurement of capacity is 20 °C.
1.2. Position for correct indication: free standing on a level surface.
2. MPEs
Table 1
|
|
Line |
Brim |
|
Transfer measures |
|
|
|
< 100 ml |
± 2 ml |
– 0 + 4 ml |
|
≥ 100 ml |
± 3 % |
– 0 + 6 % |
|
Serving measures |
|
|
|
< 200 ml |
± 5 % |
– 0 + 10 % |
|
≥ 200 ml |
± (5 ml + 2,5 %) |
– 0 + 10 ml + 5 % |
3. Materials
Capacity serving measures shall be made of material which is sufficiently rigid and dimensionally stable to maintain capacity within the MPE.
4. Shape
4.1. Transfer measures shall be designed so that a change of contents equal to the MPE causes a change in level of at least 2 mm at the brim or filling mark.
4.2. Transfer measures shall be designed so that the complete discharge of the liquid being measured will not be impeded.
5. Marking
5.1. The nominal capacity declared shall be clearly and indelibly marked on the measure.
5.2. Capacity serving measures may also be marked with up to three clearly distinguishable capacities, none of which shall lead to confusion one to the other.
5.3. All filling marks shall be sufficiently clear and durable to ensure that MPEs are not exceeded in use.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
A2 or F1 or D1 or E1 or B + E or B + D or H.
ANNEX XI
DIMENSIONAL MEASURING INSTRUMENTS (MI-009)
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to dimensional measuring instruments of the types defined below.
DEFINITIONS
|
Length measuring instrument |
A length measuring instrument serves for the determination of the length of rope-type materials (e.g. textiles, bands, cables) during feed motion of the product to be measured. |
|
Area Measuring Instruments |
An area measuring instrument serves for the determination of the area of irregular shaped objects, e.g. for leather. |
|
Multi-dimensional Measuring Instruments |
A multi-dimensional measuring instrument serves for the determination of the edge length (length, height, width) of the smallest enclosing rectangular parallelepiped of a product. |
CHAPTER I
Requirements common to all dimensional measuring instruments
Electromagnetic immunity
1. The effect of an electromagnetic disturbance on a dimensional measuring instrument shall be such that:
2. The critical change value is equal to one scale interval.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
CHAPTER II
Length measuring instruments
Characteristics of the product to be measured
1. Textiles are characterised by the characteristic factor K. This factor takes the stretchability and force per unit area of the product measured into account and is defined by the following formula:
|
K |
= |
ε is the relative elongation of a cloth specimen 1 m wide at a tensile force of 10 N, GA is the weight force per unit area of a cloth specimen in N/m2. |
Operating conditions
2.1. Range
Dimensions and K-factor, where applicable, within the range specified by the manufacturer for the instrument. The ranges of K-factor are given in Table 1:
Table 1
|
Group |
Range of K |
Product |
|
I |
0 < K < 2 × 10–2 N/m2 |
low stretchability |
|
II |
2 × 10–2 N/m2 < K < 8 × 10–2 N/m2 |
medium stretchability |
|
III |
8 × 10–2 N/m2 < K < 24 × 10–2 N/m2 |
high stretchability |
|
IV |
24 × 10–2 N/m2 < K |
very high stretchability |
|
2.2. |
Where the measured object is not transported by the measuring instrument, its speed must be within the range specified by the manufacturer for the instrument. |
|
2.3. |
If the measurement result depends on the thickness, the surface condition and the kind of delivery (e.g. from a big roll or from a pile), corresponding limitations are specified by the manufacturer. |
MPEs
3. Instrument
Table 2
|
Accuracy class |
MPE |
|
I |
0,125 %, but not less than 0,005 Lm |
|
II |
0,25 %, but not less than 0,01 Lm |
|
III |
0,5 %, but not less than 0,02 Lm |
Where Lm is the minimum measurable length, that is to say the smallest length specified by the manufacturer for which the instrument is intended to be used.
The true length value of the different types of materials shall be measured using suitable instruments (e.g. tapes of length). Thereby, the material which is going to be measured shall be laid out on a suitable underlay (e.g. a suitable table) straight and unstretched.
Other requirements
4. The instruments must ensure that the product is measured unstretched according to the intended stretchability for which the instrument is designed.
CHAPTER III
Area measuring instruments
Operating conditions
1.1. Range
Dimensions within the range specified by the manufacturer for the instrument.
1.2. Condition of the product
The manufacturer shall specify the limitations of the instruments due to the speed, and thickness of the surface conditions if relevant, of the product.
MPEs
2. Instrument
The MPE is 1,0 %, but not less than 1 dm2.
Other requirements
3. Presentation of the product
In the case of pulling back or stopping the product, it shall not be possible to have an error of measurement or the display must be blanked.
4. Scale interval
The instruments must have a scale interval of 1,0 dm2. In addition, it must be possible to have a scale interval of 0,1 dm2 for testing purposes.
CHAPTER IV
Multidimensional measuring instruments
Operating conditions
1.1. Range
Dimensions within the range specified by the manufacturer for the instrument.
1.2. Minimum dimension
The lower limit of the minimum dimension for all values of the scale interval is given in Table 1.
Table 1
|
Scale interval (d) |
Minimum dimension (min) (lower limit) |
|
d ≤ 2 cm |
10 d |
|
2 cm < d ≤ 10 cm |
20 d |
|
10 cm < d |
50 d |
1.3. Speed of the product
The speed must be within the range specified by the manufacturer for the instrument.
MPE
2. Instrument:
The MPE is ± 1,0 d.
ANNEX XII
EXHAUST GAS ANALYSERS (MI-010)
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex, apply to exhaust gas analysers defined below intended for inspection and professional maintenance of motor vehicles in use.
DEFINITIONS
|
Exhaust gas analyser |
An exhaust gas analyser is a measuring instrument that serves to determine the volume fractions of specified components of the exhaust gas of a motor vehicle engine with spark ignition at the moisture level of the sample analysed. These gas components are carbon monoxide (CO), carbon dioxide (CO2), oxygen (O2) and hydrocarbons (HC). The content of hydrocarbons has to be expressed as concentration of n-hexane (C6H14), measured with near-infrared absorption techniques. The volume fractions of the gas components are expressed as a percentage (% vol) for CO, CO2 and O2 and in parts per million (ppm vol) for HC. Moreover, an exhaust gas analyser calculates the lambda value from the volume fractions of the components of the exhaust gas. |
|
Lambda |
Lambda is a dimensionless value representative of the burning efficiency of an engine in terms of air/fuel ratio in the exhaust gases. It is determined with a reference standardised formula. |
SPECIFIC REQUIREMENTS
Instrument Classes
1. Two classes (0 and I) are being defined for exhaust gas analysers. The relevant minimum measuring ranges for these classes are shown in Table 1.
Table 1
|
Classes and measuring ranges |
|
|
Parameter |
Classes 0 and I |
|
CO fraction |
from 0 to 5 % vol |
|
CO2 fraction |
from 0 to 16 % vol |
|
HC fraction |
from 0 to 2 000 ppm vol |
|
O2 fraction |
from 0 to 21 % vol |
|
λ |
from 0,8 to 1,2 |
Rated operating conditions
2. The values of the operating conditions shall be specified by the manufacturer as follows:
For the climatic and mechanical influence quantities:
For the electrical power influence quantities:
For the ambient pressure:
Maximum permissible errors (MPEs)
3. The MPEs are defined as follows:
For each of the fractions measured, the maximum error value permitted under rated operating conditions according to point 1.1 of Annex I is the greater of the two values shown in Table 2. Absolute values are expressed in % vol or ppm vol, percentage values are percent of the true value.
Table 2
|
MPEs |
||
|
Parameter |
Class 0 |
Class I |
|
CO fraction |
± 0,03 % vol ± 5 % |
± 0,06 % vol ± 5 % |
|
CO2 fraction |
± 0,5 % vol ±5 % |
± 0,5 % vol ± 5 % |
|
HC fraction |
± 10 ppm vol ± 5 % |
± 12 ppm vol ± 5 % |
|
O2 fraction |
± 0,1 % vol ± 5 % |
± 0,1 % vol ± 5 % |
The MPE on lambda calculation is 0,3 %. The conventional true 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) ( 14 ).
For this purpose, the values displayed by the instrument are used for calculation.
Permissible effect of disturbances
4. For each of the volume fractions measured by the instrument, the critical change value is equal to the MPE for the parameter concerned.
5. The effect of an electromagnetic disturbance shall be such that:
Other requirements
6. The resolution shall be equal to or of one order of magnitude higher than the values shown in Table 3.
Table 3
|
Resolution |
||||
|
|
CO |
CO2 |
O2 |
HC |
|
Class 0 and class I |
0,01 % vol |
0,1 % vol |
1 ppm vol |
|
|
(1)
0,01 % vol for measurand values below or equal to 4 % vol, otherwise 0,1 % vol. |
||||
The lambda value shall be displayed with a resolution of 0,001.
7. The standard deviation of 20 measurements shall not be greater than one third of the modulus of the MPE for each applicable gas volume fraction.
8. For measuring CO, CO2 and HC, the instrument, including the specified gas handling system, must indicate 95 % of the final value as determined with calibration gases within 15 seconds after changing from a gas with zero content, e.g. fresh air. For measuring O2, the instrument under similar conditions must indicate a value differing less than 0,1 % vol from zero within 60 seconds after changing from fresh air to an oxygen-free gas.
9. The components in the exhaust gas, other than the components whose values are subject to the measurement, shall not affect the measurement results by more than the half of the modulus of the MPEs when those components are present in the following maximum volume fractions:
water vapor up to saturation.
10. An exhaust gas analyser shall have an adjustment facility that provides operations for zero-setting, gas calibration and internal adjustment. The adjustment facility for zero-setting and internal adjustment shall be automatic.
11. For automatic or semi-automatic adjustment facilities, the instrument shall be unable to make a measurement as long as the adjustments have not been made.
12. An exhaust gas analyser shall detect hydrocarbon residues in the gas handling system. It shall not be possible to carry out a measurement if the hydrocarbon residues, present before any measurement, exceed 20 ppm vol.
13. An exhaust gas analyser shall have a device for automatically recognising any malfunctioning of the sensor of the oxygen channel due to wear or a break in the connecting line.
14. If the exhaust gas analyser is capable to operate with different fuels (e.g. petrol or liquefied gas), there shall be the possibility to select the suitable coefficients for the Lambda calculation without ambiguity concerning the appropriate formula.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in Article 17 that the manufacturer can choose between are:
B + F or B + D or H1.
ANNEX XIII
EU DECLARATION OF CONFORMITY (No XXXX) ( 15 )
1. Instrument model/Instrument (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. Object of the declaration (identification of instrument allowing traceability; it may, where necessary for the identification of the instrument, include an image):
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
6. References to the relevant harmonised standards or normative documents used or references to the other technical specifications in relation to which conformity is declared:
7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:
8. Additional information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
ANNEX XIV
PART A
Repealed Directive with list of the successive amendments thereto
(referred to in Article 52)
|
Directive 2004/22/EC of the European Parliament and of the Council (OJ L 135, 30.4.2004, p. 1). |
|
|
Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). |
Only point B.3 of the Annex |
|
Regulation (EC) No 1137/2008 of the European Parliament and of the Council (OJ L 311, 21.11.2008, p. 1). |
Only point 3.8 of the Annex |
|
Commission Directive 2009/137/EC (OJ L 294, 11.11.2009, p. 7). |
|
|
Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). |
Only point (g) of Article 26(1) |
PART B
Time-limits for transposition into national law and dates of application
(referred to in Article 52)
|
Directive |
Time limit for transposition |
Date of application |
|
2004/22/EC |
30 April 2006 |
30 October 2006 |
|
2006/96/EC |
|
|
|
2009/137/EC |
1 December 2010 |
1 June 2011 |
ANNEX XV
CORRELATION TABLE
|
Directive 2004/22/EC |
This Directive |
|
Article 1 |
Article 2(1) |
|
Article 2 |
Article 3 |
|
Article 3, first paragraph |
Article 1 |
|
Article 3, second paragraph |
Article 2(2) |
|
Article 4 |
Article 4(1) to (4), (6) to (9) |
|
— |
Article 4(5) and (10) to (22) |
|
Article 5 |
Article 5 |
|
Article 6(1) |
Article 6 |
|
Article 6(2) |
— |
|
Articles 7(1) |
Article 20 |
|
Article 7(2) |
Article 22(4) |
|
Article 7(3) |
— |
|
Article 7(4) |
— |
|
Article 8 |
Article 7 |
|
— |
Article 8 |
|
— |
Article 9 |
|
— |
Article 10 |
|
— |
Article 11 |
|
— |
Article 12 |
|
— |
Article 13 |
|
Article 9 |
Article 17 |
|
Article 10 |
Article 18 |
|
Article 11(1) |
— |
|
Article 11(2), first subparagraph |
— |
|
Article 11(2), second subparagraph |
Article 23(2) |
|
Article 12 |
— |
|
Article 13(1) |
— |
|
Article 13(2) |
— |
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Article 14(1) |
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Article 14(2) |
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Article 13(3) |
Article 14(3) |
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Article 13(4) |
Article 14(4) |
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Article 14 |
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Article 15(1) |
Article 46(1) |
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Article 15(2) |
Article 46(3) |
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Article 15(3) |
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Article 15(4) |
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Article 15(5) |
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Article 16(1) |
Article 15 |
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Article 16(2) |
Article 47 |
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Article 16(3) |
Article 16 |
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Article 16(4) |
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Article 17(1) |
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Article 17(2) |
Article 21(2) |
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Article 17(3) |
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Article 17(4), first subparagraph |
Article 22(2) |
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Article 17(4), second subparagraph |
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Article 17(5) |
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Article 18 |
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Article 19 |
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Article 21(1) |
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Article 22(1) |
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Article 22(3) |
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Article 22(5), second subparagraph |
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Article 22(5), third subparagraph |
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Article 22(6) |
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Article 23 |
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Article 24 |
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Article 25 |
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Article 26 |
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Article 27 |
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Article 28 |
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Article 29 |
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Article 31 |
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Article 32 |
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Article 33 |
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Article 34 |
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Article 35 |
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Article 36 |
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Article 37 |
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Article 38 |
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Article 39 |
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Article 40 |
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Article 19(1) |
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Article 19(2)(a), first subparagraph |
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Article 19(2)(a), second subparagraph |
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Article 19(2)(a), third subparagraph |
Article 43(4) |
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Article 19(2)(b) |
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Article 20 |
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Article 21 |
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Article 22 |
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Article 23 |
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Article 41 |
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Article 42 |
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Article 43(1) |
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Article 43(2) |
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Article 43(3) |
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Article 44 |
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Article 45 |
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Article 48 |
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Article 49 |
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Article 50 |
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Article 24 |
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Article 51 |
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Article 25 |
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Article 52 |
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Article 26 |
Article 53, first paragraph |
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Article 53, second paragraph |
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Article 27 |
Article 54 |
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Annex I |
Annex I |
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Annex A |
Annex II, point 1 |
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Annex A1 |
Annex II, point 2 |
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Annex B |
Annex II, point 3 |
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Annex C |
Annex II, point 4 |
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Annex C1 |
Annex II, point 5 |
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Annex D |
Annex II, point 6 |
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Annex D1 |
Annex II, point 7 |
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Annex E |
Annex II, point 8 |
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Annex E1 |
Annex II, point 9 |
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Annex F |
Annex II, point 10 |
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Annex F1 |
Annex II, point 11 |
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Annex G |
Annex II, point 12 |
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Annex H |
Annex II, point 13 |
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Annex H1 |
Annex II, point 14 |
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Annex MI-001 |
Annex III |
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Annex MI-002 |
Annex IV |
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Annex MI-003 |
Annex V |
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Annex MI-004 |
Annex VI |
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Annex MI-005 |
Annex VII |
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Annex MI-006 |
Annex VIII |
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Annex MI-007 |
Annex IX |
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Annex MI-008 |
Annex X |
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Annex MI-009 |
Annex XI |
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Annex MI-010 |
Annex XII |
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Annex XIV |
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Annex XV |
( 1 ) OJ C 181, 21.6.2012, p. 105.
( 2 ) Position of the European Parliament of 5 February 2014 (not yet published in the Official Journal) and decision of the Council of 20 February 2014.
( 3 ) OJ L 135, 30.4.2004, p. 1.
( 4 ) See Annex XIV, Part A.
( 5 ) OJ L 218, 13.8.2008, p. 30.
( 6 ) OJ L 218, 13.8.2008, p. 82.
( 7 ) OJ L 390, 31.12.2004, p. 24.
( 8 ) OJ L 316, 14.11.2012, p. 12.
( 9 ) OJ L 55, 28.2.2011, p. 13.
( 10 ) Directive 2014/30/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 electromagnetic compatibility (see page 79 of this Official Journal).
( 11 ) OJ L 283, 31.10.2003, p. 51.
( 12 ) OJ L 46, 21.2.1976, p. 1.
( 13 ) The distance signal generator is outside the scope of this Directive.
( 14 ) OJ L 42, 15.2.2012, p. 1.
( 15 ) It is optional for the manufacturer to assign a number to the declaration of conformity.