Government Regulation No. 120 / 2016 Coll.
Government Regulation on conformity assessment of measuring instruments when making them available on the market
Valid
Effective from 20.04.2016
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120
GOVERNMENT REGULATION
of 30 March 2016
on the conformity assessment of measuring instruments when making them available on the market
The Government mandates, pursuant to Sections 4 and 50 (5) of Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market ("the Act '):
Subject matter
(1) This Regulation implements the relevant provisions of the European Union1) and regulates the technical requirements for measuring instruments to be met when placed on the market, the conditions and procedures for making them available on the market and the conformity assessment methods.
(2) This Regulation shall apply to the following measuring instruments intended to be used for measurement in binding relations, in consumer protection, in the setting of penalties, charges, tariffs and taxes, in the context of environmental protection, in the context of ensuring public safety and order, in the context of the protection of public health, or in the context of the protection of other public interests protected by other legislation4), which are products intended for conformity assessment under Article 4 of the Act:
(a) water meters (MI-001) whose definitions, specific requirements and conformity assessment are laid down in Annex 3 to this Regulation;
(b) gas meters and gas recalculators (MI- 002) and their sub-assemblies, the definitions, specific requirements, putting into service and conformity assessment set out in Annex 4 to this Regulation;
(c) electrometers for measuring active energy (MI- 003), the definitions, specific requirements and conformity assessment of which are laid down in Annex 5 to this Regulation;
(d) heat energy meters (MI-004) and their sub-assemblies, the definitions of which are specific requirements, the putting into service and conformity assessment laid down in Annex 6 to this Regulation;
(e) measuring systems for continuous and dynamic measurement of quantities of liquids other than water (MI- 005), the definitions, specific requirements and conformity assessment of which are laid down in Annex 7 to this Regulation;
(f) automatic weighing instruments (MI- 006) whose definitions, specific requirements and conformity assessment are set out in Annex 8 to this Regulation;
(g) taximeters (MI-007) whose definitions, requirements for them and conformity assessment are set out in Annex 9 to this Regulation;
(h) the embodied rates (MI- 008), the definitions, specific requirements and conformity assessment of which are set out in Annex 10 to this Regulation;
(i) measuring instruments for measuring dimensions (MI-009), the definitions and conformity assessment of which are set out in Annex 11 to this Regulation; and
(j) exhaust gas analysers (MI-010) whose definitions, specific requirements and conformity assessment are laid down in Annex 12 to this Regulation.
(3) The assessment of electromagnetic compatibility of the gauge shall be carried out in accordance with this Regulation as regards electromagnetic resistance. With regard to electromagnetic radiation, the Government's regulation governing the conformity assessment of products with regard to their electromagnetic compatibility shall be followed.
Definition of terms
This Regulation shall mean:
(a) a measuring instrument or system with a measuring function as referred to in Section 1 (2);
(b) a subset of technical equipment which operates independently and forms a measuring instrument together with other sub-assemblies with which it is compatible or with a measuring instrument with which it is compatible;
(c) a standard document containing the technical specifications adopted by the International Organisation for Legal Metrology;
(d) metrological control of the operation of the meter for its use for reasons of public interest, protection of public health, public safety, public order, environmental protection, collection of taxes and charges, consumer protection and fair trade.
Technical requirements for gauges
The technical requirements for measuring instruments are the general requirements set out in Annex 1 to this Regulation and the specific requirements set out for each type of measuring instrument in the relevant Annex to this Regulation for that type of measuring instrument (hereinafter referred to as "basic technical requirements'). Compliance with the essential technical requirements shall be demonstrated by conformity assessment.
Making available on the market and putting into service
(1) Measurements may be made available on the market or put into service only if the requirements of this Regulation are met.
(2) At trade fairs, exhibitions, demonstrations or similar events, measuring instruments which are not in conformity with this Regulation may be presented, provided that it is clear from the visible indication that they are not in conformity and that they cannot be made available on the market or put into service until they have been brought into conformity.
(3) Where the relevant Annex to this Regulation defines different classes of accuracy for a measuring instrument and at the same time indicates which classes are to be used for certain applications, the measuring instrument may be put into service for a given application only if it corresponds to a specified or better class.
Manufacturer
(1) When placing on the market or putting into service of measuring instruments, the manufacturer shall ensure that such measuring instruments are designed and manufactured in accordance with Annex 1 to this Regulation and the specific Annexes to this Regulation for each type of measuring instrument, draw up the technical documentation provided for in Section 12 and carry out or have carried out the conformity assessment procedure set out in Section 10.
(2) Where the conformity of a measuring instrument with the requirements laid down in the conformity assessment procedure referred to in the relevant Annex to this Regulation has been demonstrated, the manufacturer shall draw up an EU declaration of conformity and place the CE marking and the supplementary metrological marking on the measuring instrument.
(3) The manufacturer shall keep the technical documentation and the EU declaration of conformity for 10 years from the placing on the market of the measuring instrument.
(4) The manufacturer shall carry out tests on samples of gauges made available on the market and on-the-spot checks, if necessary in relation to the operation of the gauge. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the existing risk posed by the gauge in relation to the manufacturer's intended purpose of use. The manufacturer shall keep a register of complaints, non-compliant measuring instruments and recall of measuring instruments and shall keep distributors informed of such activities.
(5) The manufacturer shall ensure that a type or series number or serial number or other element enabling its identification is indicated on the measuring instrument which he has placed on the market or, in cases where the size or nature of the measuring instrument does not allow the required information to be given on the document accompanying the measuring instrument and on the packaging, if the measuring instrument is packed, in accordance with point 9.2 of Annex 1 to this Regulation.
(6) The manufacturer shall indicate on the measuring instrument or, if this is not possible, on the document attached to the measuring instrument and on the packaging, if the measuring instrument is packed, his name or business name or trade mark, as the case may be, and the address for service at which he may be contacted in accordance with point 9.2 of Annex 1 to this Regulation. The delivery address shall be the address of the place at which the manufacturer can actually be contacted. The contact details shall be in a language easily understood by end-users and supervisory authorities.
(7) The manufacturer shall ensure that the measuring instrument which he makes available on the market is accompanied by a copy of the EU declaration of conformity and instructions and the information referred to in point 9.3 of this Regulation and that it is provided with the information referred to in points 9.1 or 9.2 of Annex 1 to this Regulation which is clear, understandable and easily understandable to users; a copy of the EU declaration of conformity, instructions and information referred to in point 9 of Annex 1 to this Regulation or in the relevant Annexes to this Regulation shall be given in the Czech language.
Authorised representative
The authorised representative shall keep the EU declaration of conformity and the technical documentation at the disposal of the supervisory authority for 10 years from the placing on the market of the measuring instrument.
Importer
(1) Before placing the measuring instrument on the market or putting into service, the importer shall ensure that the manufacturer carries out the conformity assessment procedure referred to in Article 10, that the manufacturer draws up the technical documentation, that the measuring instrument is bearing the CE marking and the supplementary metrological marking, that it is accompanied by a copy of the EU declaration of conformity and the required documents and that the manufacturer complies with the requirements set out in paragraphs 5 (5) and (6).
(2) The importer shall indicate on the measuring instrument or, if this is not possible, on the document attached to the measuring instrument and on its packaging, if the measuring instrument is packed, his name or business name or trade mark, as the case may be, and the address for service at which he can be contacted in accordance with point 9.2 of Annex 1 to this Regulation. The contact details shall be in a language easily understood by end-users and supervisory authorities.
(3) The importer shall ensure that the measuring instrument is accompanied by the instructions and information referred to in point 9.3 of Annex 1 to this Regulation in the Czech language.
(4) The importer shall carry out tests on samples of measuring instruments made available on the market and on the investigation, where appropriate in relation to the functioning of the measuring instrument. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the existing risk posed by the gauge in relation to the manufacturer's intended purpose of use. The importer shall keep records of complaints, non-compliant measuring instruments and withdrawal of measuring instruments and shall keep distributors informed of those activities.
(5) The importer shall, for a period of 10 years from the placing on the market of the measuring instrument, keep a copy of the EU declaration of conformity for market surveillance purposes and ensure that technical documentation may be submitted to the supervisory authorities upon request.
Distributor
The distributor shall verify before making the measuring instrument available on the market or putting it into service that:
(a) the measuring instrument has a CE marking and an additional metrological marking;
(b) a copy of the EU declaration of conformity and the required documents and instructions and information in the Czech language are attached to the measuring instrument; and
(c) the manufacturers and importers have complied with the relevant requirements set out in Articles 5 (5), 5 (6) and 7 (2).
Economic operator identification time
The operator shall keep for a period of 10 years after the delivery of the measuring instrument on the market the data by which, at the request of the supervisory authority, the economic operator who delivered the measuring instrument to him or to whom he has supplied the measuring instrument may be identified.
Conformity assessment procedures
(1) The conformity assessment procedures are set out in Annex 2 to this Regulation. For the assessment of conformity with the essential technical requirements, one of the conformity assessment procedures set out in the relevant Annex to this Regulation shall be used for that type of measuring instrument.
(2) Documents relating to conformity assessment procedures shall be drawn up in the official language or languages of the Member State of the European Union in which the notified body carrying out the conformity assessment procedures is established or in a language agreed between the manufacturer and the notified body.
(3) Subassemblies and measuring instruments may be assessed independently and separately for the purposes of determining conformity.
Presumption of conformity
(1) Where the measuring instrument complies with the harmonised standards to which the references in the Official Journal of the European Union or parts thereof, or parts thereof, or parts of the normative documents, the list of which has been published in the Official Journal of the European Union, it shall be deemed to comply with the essential technical requirements to which those standards or parts of them or parts of them, as the case may be, of those normative documents.
(2) The manufacturer may choose any technical solution which meets the essential technical requirements. In order to benefit from the presumption of conformity, the manufacturer shall correctly apply the solutions set out in the relevant harmonised standards or normative documents.
(3) If an appropriate test programme has been carried out in accordance with the relevant documents referred to in paragraph 1 and if the test results ensure compliance with the essential technical requirements, the gauges shall be deemed to comply with the tests referred to in paragraph 12 (3) (i).
Technical documentation
(1) The technical documentation shall describe the design, manufacture and operation of the measuring instrument and shall allow for an assessment of its conformity with the relevant requirements of this Regulation.
(2) The technical documentation must be sufficiently detailed to ensure compliance with the following requirements:
(a) determination of metrological characteristics;
(b) the reproducibility of the metrological functions of the measuring instruments manufactured, if they are correctly justified by appropriate means; and
(c) the integrity of the gauge.
(3) The technical documentation shall include the following information if it is necessary for the assessment and identification of the type of measuring instrument or the identification of the measuring instrument:
(a) a general description of the gauge;
(b) conceptual design, manufacturing drawings and schematics of components, sub-assemblies, circuits and, where appropriate, other design documentation;
(c) production processes ensuring uniformity of production;
(d) where appropriate, a description of electronic equipment with drawings, diagrams, development diagrams of logic circuits and general information on the characteristics and function of software elements;
(e) descriptions and explanations necessary for understanding the facts referred to in points (b), (c) and (d), including the operation of the measuring instrument;
(f) the list of harmonised standards or normative documents referred to in Article 11 to which references have been published in the Official Journal of the European Union and which have been used in full or in part;
(g) descriptions of the solutions chosen to meet the essential technical requirements, where harmonised standards or normative documents have not been used pursuant to Article 11, including a list of other relevant technical specifications used;
(h) the results of design calculations, checks carried out and similar activities;
(i) if necessary, test results demonstrating that the type or gauge complies with:
1. with the requirements of this Regulation under declared specified working conditions and with specified disturbances originating from the environment; and
2. with stability specifications for gas meters, water meters, heat energy meters and for measuring systems for liquids other than water; and
(j) an EU type-examination certificate or an EU design examination certificate for measuring instruments containing parts identical to those used in the design of the measuring instrument.
(4) The manufacturer shall indicate in the technical documentation where he has placed the seals and markings.
(5) The manufacturer shall indicate in the technical documentation any conditions to be complied with for compatibility with interfaces and sub-assemblies.
EU declaration of conformity
(1) The EU declaration of conformity demonstrates compliance with the essential requirements set out in Annex 1 to this Regulation and those set out in the relevant Annexes to this Regulation.
(2) The EU declaration of conformity shall be drawn up in accordance with the model set out in Annex 13 to this Regulation. The declaration shall contain the information set out in the relevant modules listed in Annex 2 to this Regulation and shall be kept up to date. The EU declaration of conformity shall also be translated into the language (s) required by the Member State of the European Union in which the measuring instrument is placed or made available on the market.
(3) Where a measuring instrument is covered by several European Union harmonisation rules providing for the drawing up of an EU declaration of conformity, a single EU declaration of conformity shall be drawn up with the references to all those rules under which conformity has been assessed, including the references to their publication. This single EU declaration of conformity may take the form of a component consisting of declarations of conformity issued for each Regulation.
CE marking and other markings
(1) The CE marking and the supplementary metrological marking shall be placed on the measuring instrument or on its production label before it is placed on the market. Where this is not possible or justified due to the nature of the gauge, it shall be placed on accompanying documents and on the packaging if the gauge is packed. The CE marking and the supplementary metrological marking may, where justified, be placed on the gauge during the production process.
(2) If the gauge consists of a set of devices which are not subassemblies but which work together, the CE marking and the supplementary metrological marking shall be placed on the main equipment of the gauge.
(3) The supplementary metrological marking consists of the capital letter "M" and the last two digits of the year in which it was placed, enclosed by a rectangle whose height is equal to the height of the CE marking. The supplementary metrological marking shall be followed immediately by the CE marking. The CE marking procedure shall apply mutatis mutandis to supplementary metrological marking.
(4) The CE marking and the supplementary metrological marking shall be followed by the identification number of the notified body or bodies involved in the control phase of production in accordance with Annex 2 to this Regulation. The identification number of the notified body concerned shall be indelible or placed in such a way that it cannot be removed without damage.
(5) The CE marking, the supplementary metrological marking and the identification number of the notified body may be followed by any other mark indicating a particular risk or use.
Formal deficiencies
A formal deficiency shall be considered to be:
(a) the CE marking or the supplementary metrological marking has been placed in breach of Article 30 of Regulation (EC) No 765 / 2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93 or Article 14;
(b) the CE marking or the supplementary metrological marking has not been affixed;
(c) the identification number of the notified body involved in the control phase of production has been placed in contravention of Section 14 or has not been located;
(d) the EU declaration of conformity has not been attached to the measuring instrument;
(e) the EU declaration of conformity has not been drawn up in accordance with this Regulation;
(f) the technical documentation is missing or incomplete;
(g) the information referred to in Article 5 (6) or Article 7 (2) is missing or is incorrect or incomplete; or
(h) the other administrative requirement referred to in § 5 or § 7 or the administrative requirement referred to in § 6 (1), (5) or (6) or § 8 (1), (3), (6) or (7) of the Act has not been met.
Transitional provisions
(1) Measurements complying with the requirements of Government Regulation 464 / 2005 Coll. may continue to be made available on the market and put into service if they were placed on the market before the date of entry into force of this Regulation.
(2) Valid certificates and other documents certifying the facts established issued by the notified persons under Government Regulation 464 / 2005 Coll. remain valid and shall be considered as certificates and other documents certifying the facts established under this Regulation.
(3) Meters complying with the requirements laid down by the legislation in force before the date of entry into force of Government Decree No. 464 / 2005 Coll. may continue to be placed on the market and put into service until the expiry of the type-approval of such measuring instruments, but not later than 30 October 2016.
Repeal
They shall be deleted:
1. Government Decree No. 464 / 2005 Coll., laying down technical requirements for measuring instruments.
2. Government Regulation No. 246 / 2010 Coll., amending Government Regulation No. 464 / 2005 Coll., laying down technical requirements for measuring instruments.
Efficacy
This Regulation shall enter into force on 20 April 2016.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.
Příloha č. 1
Annex No 1 to Government Regulation No 120 / 2016 Coll.
GENERAL REQUIREMENTS
The measuring instrument shall provide a high level of metrological protection so that each person concerned can have confidence in the result of measurements and shall be designed and manufactured with high quality in terms of measurement technology and the safety of measured values.
The essential requirements to be met by measuring instruments are set out below and supplemented, if necessary, by the specific requirements for individual types of measuring instruments set out in Annexes 3 to 12 to this Regulation which are much more detailed in certain aspects of the general requirements.
The solutions adopted with regard to the essential requirements shall take into account the intended use of the gauge and its foreseeable misuse.
DEFINITIONS
Measured quantity
The measured quantity is a specified quantity which is the subject of the measurement.
Influencing variable
The influencing variable is a variable that is not a measured quantity but affects the result of the measurement.
Fixed working conditions
The specified working conditions are the values of the measured variable and the influencing quantities that make up the normal working conditions of the meter.
Interference
The interference is a variable whose value lies within the limits specified by a particular requirement but is outside the specified working conditions of the gauge. The influencing variable is a interference if the specified working conditions are not specified for such influencing variable.
Critical change value
The critical change value is the value at which the change in the measurement result is considered undesirable.
Incentive rate
The embodied measure is a device designed to reproduce or provide one or more known values of the variable in a permanent manner during use.
Direct sales
A commercial transaction is a direct sale if:
(a) the result of the measurement serves as a basis for determining the price to be paid;
(b) at least one of the parties to this transaction associated with measurement is the consumer or any other person requiring a similar level of protection; and
(c) all parties to the transaction accept the result of the measurements at a given time and place.
Climate
The climatic environment is the conditions under which gauges can be used. A number of temperature ranges were defined in order to take account of climate differences between Member States.
Distribution company
The supplier of electricity, gas, heat or water shall be considered as a distribution company.
ESSENTIAL REQUIREMENTS
1. Allowed errors
1.1. Under specified working conditions and without interference, the measurement error shall not exceed the value of the largest permissible error (MPE) set out in the relevant requirements for the gauge.
Unless otherwise specified in the separate Annexes to this Regulation for each type of measuring instrument, the MPE shall be expressed as a bilateral value of the deviation from the conventional right measurement value.
1.2 Under specified working conditions and in the event of interference, the requirement to operate shall comply with the relevant specific requirements for the type of gauge.
If the gauge is intended to be used in a specified continuous electromagnetic field, its permissible measurement characteristics during the test in a radiated high frequency electromagnetic field with amplitude modulation shall lie within the MPE limits.
1.3. The manufacturer shall determine the climatic, mechanical and electromagnetic environments in which the measuring instrument is to be used, the power supply and other influencing quantities which could affect its accuracy, taking into account the requirements set out in the relevant specific Annexes to this Regulation for each type of measuring instrument.
1.3.1. Climate
Unless otherwise specified in Annexes 3 to 12 to this Regulation, the manufacturer shall determine the upper temperature limit and the lower temperature limit of the values given in Table 1 and shall indicate whether the gauge is designed for condensation moisture or condensation moisture, as well as the intended position of the gauge, i.e. in open or enclosed space.
Table 1
| Teplotní meze | ||||
|---|---|---|---|---|
| Horní teplotní mez | 30 °C | 40 °C | 55 °C | 70 °C |
| Dolní teplotní mez | 5 °C | -10 °C | -25 °C | -40 °C |
1.3.2.
(a) The mechanical environment is divided into classes M1 to M3 as described below.
M1
This class shall apply to gauges which are used in premises with insignificant vibrations and impacts, in particular to gauges fixed to lighter support structures which are exposed to negligible vibrations and shocks due to local activities related to pressure waves, impacts, door banging.
M2
This class applies to gauges used in premises with significant or high levels of vibration and impact, in particular carried from machines and passing vehicles in close proximity or adjacent to heavy machinery, conveyor belts.
M3
This class applies to gauges used in premises where there is a high or very high level of vibration and impact, in particular gauges mounted directly on machines, conveyor belts.
(b) In relation to the mechanical environment, the following influencing quantities should be considered:
1. vibration,
2. mechanical shocks.
1.3.3.
(a) Unless otherwise specified in the relevant specific Annexes to this Regulation for each type of measuring instrument, the electromagnetic environment shall be divided into classes E1, E2, E3 as set out below.
E1
This class applies to gauges which are used in spaces with electromagnetic interference corresponding to disturbances which can be encountered in residential, commercial and light industrial buildings.
E2
This class applies to gauges used in premises with electromagnetic interference corresponding to the interference that can be encountered in other industrial buildings.
E3
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Regulation Information
| Citation | Government Regulation No. 120 / 2016 Coll., on the conformity assessment of meters when making them available on the market |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.04.2016 |
|---|---|
| Effective from | 20.04.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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