120/2016 Sb.
GOVERNMENT REGULATION
of 30 March 2004. March 2016
on conformity assessment of measuring instruments when they are making available on the market
The Government directs pursuant to § 4 and § 50 para. 5 of law No. 90/2016 Coll.
conformity assessment of specified products when they are making available on the market (hereinafter
"the Act"):
§ 1
The subject of the edit
(1) this regulation incorporates the relevant provisions of the European Union ^ 1) and
regulates the technical requirements on the gauge, which shall meet at
placing on the market, the conditions and procedures for their marketing and ways of
conformity assessment.
(2) this Regulation applies to the following measuring instruments which are
products intended for conformity assessment pursuant to section 4 of the Act:
and) water meters (MI-001), whose definition, the specific requirements and the assessment of
conformity set out in annex 3 to this regulation,
(b)), gas meters and volume conversion devices (MI-002), and their
the subreport whose definitions, special requirements, commissioning and
assessment of conformity set out in annex 4 to this regulation,
(c) to measure active electrical energy meters) (MI-003), whose definitions,
the specific requirements and assessment of conformity set out in annex 5 to this
Regulation,
(d)), the thermal energy meters (MI-004), and their subassemblies, whose
definition, the specific requirements, commissioning and conformity assessment
set out in annex 6 to this regulation,
e) measuring systems for continuous and dynamic measurement of quantities of liquids
other than water (MI-005), whose definition, the specific requirements and
assessment of conformity set out in annex # 7 to this regulation,
f) automatic weighing instruments (MI-006), whose definition, special
requirements and assessment of conformity set out in annex 8 to this regulation,
(g)), taximeters (MI-007), the definitions, requirements, and assessments
conformity set out in annex 9 to this regulation,
h) typified by the measures (MI-008), whose definition, the specific requirements and
assessment of conformity set out in annex No 10 to this regulation,
I) gauge for measuring dimensions (MI-009), whose definition and assessment
conformity set out in annex 11 to this regulation, and
(j)) exhaust gas analysers (MI-010), whose definition, special
requirements and assessment of conformity set out in annex 12 to this regulation.
(3) in assessing the electromagnetic compatibility of a measuring instrument shall be treated
under this regulation, as regards electromagnetic resistance. If
as for the electromagnetic radiation, under government regulation
governing the assessment of conformity of products in terms of their
electromagnetic compatibility.
§ 2
Definition of terms
In this regulation means
and) the meter device or system with a measurement function, referred to in § 1 (1).
2,
(b)) technical devices that sub-assembly works independently and form
the gauge together with other sub-assemblies with which it is compatible, or
with a measuring instrument with which it is compatible,
c) normative document document contains technical
specifications adopted by the International Organization for legal metrology,
(d) the metrological control of functioning of the control) of the gauge for its use
for reasons of public interest, public health, public
security, public order, protection of the environment, effectively
taxes and duties, protection of consumers and fair trading.
§ 3
Technical requirements for measuring instruments
Technical requirements on the gauge are the General requirements laid down in
Annex 1 to this regulation and the specific requirements laid down for the
the different types of measuring instruments in the relevant annex to this regulation for the
a kind of measuring instrument (hereinafter referred to as "basic technical requirements"). Meet
the basic technical requirements to prove the conformity assessment.
§ 4
Making available on the market and putting into service
(1) the Gauges can be supplied on the market or put into service only
If the requirements of this regulation are met.
(2) For trade fairs, exhibitions, demonstrations or similar events can be
perform the gauge, which are not in conformity with this regulation, in
provided that a visible sign clearly indicates that they are not in
conformity and that cannot be delivered on the market or put into service until
will not be brought into conformity.
(3) If the relevant annex to this regulation defines the meter
different accuracy classes and also indicates which class to use for the
certain applications, can be used to gauge for the application entered into service only
If it matches the indicated or better class.
§ 5
The manufacturer of the
(1) when placing the measuring instruments on the market or putting into service of the manufacturer shall ensure that the
This gauge has been designed and constructed in accordance with Annex 1 to the
This regulation and the specific annexes to this regulation for each of the
types of gauges, shall establish the technical documentation as provided for in section 12, and
carry out or have carried out the conformity assessment procedure provided for in § 10.
(2) if compliance with the established requirements of the procedure of the gauge
conformity assessment in accordance with the annex to this regulation shown,
manufacturers shall draw up the EU Declaration of conformity and the CE marking placed on a gauge
and the supplementary metrology marking.
(3) the manufacturer shall keep the technical documentation and the EU Declaration of conformity
period of 10 years from putting a meter on the market.
(4) the manufacturer shall carry out sample testing of measuring instruments that came on the market, and the investigation,
If it is necessary due to the operation of the instrument. These tests and investigations
shall be carried out to the extent necessary to confirm or rebut the
of the risks involved, which represents the gauge due to the manufacturer
its intended purpose of use. The producer keeps records of complaints,
non-complying measuring instruments and measuring instrument recalls, and such
activities inform distributors.
(5) the manufacturer shall ensure that on the gauge, which it placed on the market, stated
type or number of the batch or serial number or other element allowing its
identification, or, where the size or nature of the gauge
does not allow, that the required information is given in a document accompanying
the measuring instrument and on the package if the meter is packed, in accordance with section 9.2 of the
Annex 1 to this regulation.
(6) the manufacturer shall indicate on the gauge, or, if this is not possible, in a document
accompanying the measuring instrument and on the package if the meter is packed, your name
or trade name or trademark and the address for
the service, at which he can be contacted in accordance with section 9.2 of the annex No.
1 to this regulation. Delivery address must be the address of the place in
which the manufacturer can be actually reach you. Contact details are given in the
language easily understood by end users and to the supervisory authorities.
(7) the manufacturer shall ensure that the measuring instrument, which comes on the market, accompanied by a
a copy of the EU Declaration of conformity and instruction manuals and information referred to in point 9.3 k
of this regulation, and that it bears an information referred to in points 9.1 or 9.2.
Annex 1 to this regulation, which are clear,
clear and easy to understand; a copy of the EU Declaration of conformity, instructions
and the information referred to in point 9 of annex 1 to this regulation, or in the
the relevant annexes to this Regulation shall be given in the Czech
language.
§ 6
Authorized representative
Authorized representative shall keep the EU Declaration of conformity and the technical
documentation for the requirements of a supervisory authority for a period of 10 years after the gauge
on the market.
§ 7
The importer
(1) prior to the placing of the gauge on the market and/or put into service, the importer shall ensure that the
the manufacturer has carried out the conformity assessment procedure referred to in article 10, that the manufacturer
has drawn up the technical documentation, that the gauge was marked
The CE marking and supplementary metrology marking, it was accompanied by a
a copy of the EU Declaration of conformity and the required documents and that the manufacturer has complied with the
the requirements set out in § 5 para. 5 and 6.
(2) the importer shall indicate on the gauge, or, if this is not possible, in a document
accompanying the measuring instrument and its packaging, if the meter is packed, its
name or trade name or trademark and the address for
the service, at which he can be contacted in accordance with section 9.2 of the annex No.
1 to this regulation. Contact details must be given in a language easily
understood by end-users and the supervisory authorities.
(3) the importer shall ensure that the measuring instrument is accompanied by instructions and information
referred to in point 9.3 of the annex 1 to this regulation in the Czech language.
(4) the importer carries out tests on samples of measuring instruments that came on the market, and the investigation,
If it is appropriate to the operation of the instrument. These tests and the investigation
carried out to the extent necessary for confirmation or refutation of the existing
the risk, which represents the gauge due to the intended use by the manufacturer
the use of the. The importer keeps records of complaints, of non-conforming meters and
measuring instrument recalls, and shall keep on these activities will inform the
distributors.
(5) the importer for a period of 10 years following the placing on the market of a gauge keeps a copy of the EU
Declaration of conformity at the disposal of the market surveillance authorities and ensure that the
surveillance may be submitted technical documentation on request.
§ 8
Distributor
The Distributor before you ship gauges on the market or its putting into service,
verifies whether the
and the gauge was) bears the CE marking and supplementary metrology
the designation,
(b)) the measuring instrument is accompanied by a copy of the EU Declaration of conformity and the required
documents and manuals and information in Czech language and
(c) manufacturers and importers meet) the requirements set out in § 5 para.
5 and 6 and § 7 (2). 2.
§ 9
Time for the identification of the operator
Economic operator for a period of 10 years from the delivery of the gauges on the market stores
data that can be used at the request of the supervisory authority to determine the economic
the body, which had a gauge or gauge which he added.
§ 10
The conformity assessment procedures
(1) the conformity assessment procedures set out in annex 2 to this
of the regulation. To assess compliance with the basic technical requirements
It's one of the conformity assessment procedures referred to in the annex to
This regulation for the type of gauge.
(2) the documents relating to the conformity assessment procedures shall be drawn up in
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 the
the language on which the manufacturer with this notified body agree.
(3) the subreports and the gauge can be assessed for the purposes of establishing conformity
independently and separately.
§ 11
Presumption of conformity
(1) if the meter is in conformity with the harmonised standards the references of which have been
published references in the official journal of the European Union, or parts thereof,
parts of the normative documents, where appropriate, the list of which has been published
in the official journal of the European Union, it is considered that it is in compliance with
basic technical requirements covered by those standards or their
part or parts of the normative documents, refer to.
(2) the manufacturer may choose any technical solution that complies with the
basic technical requirements. In order to take advantage of the presumption of conformity, the manufacturer
You must correctly use the solutions in the relevant harmonised
the standards or normative documents.
(3) If the corresponding test programme has been carried out in accordance with the
relevant documents referred to in paragraph 1 and if the results of
the tests ensure the conformity with the essential requirements, it is considered
that gauge meet the tests set out in § 12 para. 3 (b). I).
§ 12
The technical documentation
(1) technical documentation shall describe the design, manufacture and operation of the
the meter and shall enable assessment of its conformity with the relevant requirements of the
of this regulation.
(2) technical documentation shall be sufficiently detailed to
to comply with the following requirements:
and the) determination of the metrological characteristics,
(b)) the reproducibility of the metrological performances of produced instruments
When they are properly adjusted using appropriate intended for that purpose
resources, and
(c)) the integrity of the instrument.
(3) the technical documentation must contain the following information, if
are needed for the assessment and identification of the type of the gauge or
identification of the gauge:
and a general description of the instrument,)
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
circuit design, design documentation, if any,
(c) procedures to ensure uniformity of production) of production,
(d) where appropriate, a description of the electronic devices) with drawings, diagrams,
flowcharts, logic circuits and general information
the characteristics and function of the elements of the software,
e) descriptions and explanations necessary for the understanding of the facts referred to in
(b)), (c) and (d))), including the operation of the instrument,
(f)) for a list of the harmonized standards or normative documents referred to in section 11,
the links which have been published in the official journal of the European Union and that
were applied in full or in part,
g) descriptions of the solutions adopted to meet the essential technical
requirements have not been applied the harmonized standards or normative
documents referred to in section 11, including a list of other relevant used
technical specifications,
h) results of design calculations, examinations and similar
activities,
I) if necessary, the results of tests showing that the type or gauge
are in accordance with:
1. with the requirements of this regulation for the declared rated operating
conditions and under specified environmental disturbances, and
2. the durability specifications for gas meters, water meters, heat meters
energy and for measuring systems for liquids other than water and
(j) the EU type-examination certificate) or EU design examination certificate
for measuring instruments containing parts identical to parts that are used in the
the design of the gauge.
(4) the manufacturer in the technical documentation shall specify where seals and
the designation.
(5) the manufacturer shall indicate in the technical documentation of any conditions to which it is
to be followed for compatibility with interfaces and sub-assemblies, where relevant.
section 13 of the
EU Declaration of conformity
(1) the EU Declaration of conformity to meet the essential requirements
set out in annex 1 to this regulation and the conditions laid down 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 statement contains the information set out in
relevant modules set out in annex 2 to this regulation and shall
still be updated. EU Declaration of conformity shall be translated also into the language
or languages required by the Member State of the European Union, in which the
gauge is placed or made available on the market.
(3) If the measuring instrument is subject to more rules for harmonisation of the European
the Union providing for the elaboration of EU Declaration of conformity,
a single EU Declaration of conformity with links to all of these provisions, in accordance with
which was considered a match, including links to their publication. This
a single EU Declaration of conformity may take the form of a folder consisting of
declarations of conformity issued to individual regulations.
§ 14
The CE marking and other markings
(1) the CE marking and supplementary metrology marking shall be placed on the meter
or to its data plate before putting it on the market. If it
due to the nature of the gauge is not possible or not warranted, shall be placed on
the accompanying documents and the packaging, if the meter is packed. The CE marking and
the supplementary metrology marking may, where justified,
place the gauge during the manufacturing process.
(2) If a measuring instrument consists of a device file which are not
subreports, but working together, place the CE marking and
the supplementary metrology marking on the master device of the gauge.
(3) the supplementary metrology marking consists of the capital letter "M" and the last
two digits of the year in which it was located, bounded by the rectangle whose
height is equal to the height of the CE marking. The supplementary metrology marking
immediately follows the "CE" marking. How the CE marking apply to
the supplementary metrology marking accordingly.
(4) the CE marking and supplementary metrology marking followed by a
the identification number of the notified body or bodies that are
involved in the production control phase in accordance with Annex 2 to this
of the regulation. The identification number of the notified body, must be
indelible or located so that it is not possible without damage
delete.
(5) the CE marking, the supplementary metrology marking and,
the identification number of the notified body may be followed by any other
mark indicating a special risk or use.
§ 15
Formal defects
A formal deficiency is considered when
and) the CE marking or the supplementary metrology marking is placed in the
contrary to the article. 30 European Parliament and Council Regulation (EC) no 765/2008
of 9 June. July 2008 setting out the requirements for accreditation and
market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93, or with section 14,
(b)) the CE marking or the supplementary metrology marking has not been affixed,
(c)) identification number of the notified body involved in the control phase
production was located in violation of § 14, or not,
d) EU Declaration of conformity has not been accompanied by the measuring instrument,
e) EU Declaration of conformity has not been drawn up in accordance with this
by regulation,
f) technical documentation is missing or incomplete,
(g)) the information specified in § 5 para. 6 or § 7 para. 2 are missing, or are
incorrect or incomplete, or
(h)) was not fulfilled other administrative requirement referred to in section 5, or section 7 of the
or administrative requirement referred to in section 6 (1). 1, 5, or 6, or section 8
paragraph. 1, 3, 6, or 7 of the Act.
section 16 of the
Transitional provisions
(1) the meter meeting the requirements of Government Regulation No. 464/2005 Coll. may
continue to be supplied on the market and put into service if it was listed on the
the market at the time before the date of entry into force of this regulation.
(2) valid certificates and other documents certifying the detected
fact released persons notified pursuant to Decree-Law No.
464/2005 Coll., shall remain in force and shall be deemed the certificates and other
the documents certifying the facts established under this regulation.
(3) the measuring instrument meeting the requirements laid down by the legislation in force
before the date of entry into force of Decree-Law No. 464/2005 Coll. can be
continue to be placed on the market and put into service until the expiry of the
type approval of measuring instruments, up to 30. October 2016.
§ 17
Regulation (EEC)
Shall be deleted:
1. Government Regulation No. 464/2005 Coll. laying down technical
the requirements on the gauge.
2. Government Regulation No. 246/2010 Coll., amending Decree-Law No.
464/2005 Coll. laying down technical requirements for the gauge.
section 18
The effectiveness of the
This Regulation shall enter into force on 20 March 2004. April 2016.
Prime Minister:
Mgr. Sobotka in r.
Minister of industry and trade:
Ing. Mládek, CSc., r.
Č. 1
GENERAL REQUIREMENTS
A measuring instrument shall provide a high level of metrological protection in order that each
the person concerned can have confidence in the result of measurement, and must be designed
and constructed with high quality in terms of measurement technology and
security of the measurement values.
The essential requirements that must be met are the gauges listed below and in the
If necessary, they are supplemented by special requirements for individual species
the gauges listed in annex No. 3 to 12 of this regulation, which are
in certain aspects of the General requirements of the much more detailed.
The solutions adopted in respect of the essential requirements, it shall take into account
intended use of the instrument and any foreseeable misuse thereof.
The DEFINITION of the
Measured variable
Measured variable is specified a quantity subject to measurement.
Influence quantity
An influence quantity is a quantity that is not the measurand but
affects the result of the measurement.
Rated operating conditions
The rated operating conditions are the values for the measurand and
influence factors that make up the normal working conditions of the gauge.
Interference
Interference is affecting the quantity having a value within the limits set by
specific requirement but outside the specified rated operating conditions of the gauge.
An influence quantity is a disturbance if for that influence
quantity not specified working conditions.
The critical change value
The critical change value is the value at which the change in the measurement result
is considered undesirable.
Material measure
A material measure is a device intended to reproduce or the provision of
one or more known values of a given quantity permanently during the
the use of.
Direct sales
The business transaction is direct sales if
and the measurement result) serves as the basis for determining the price to be paid,
(b)), at least one of the parties of the transaction that is associated with the measurement,
is a consumer or any other person, requiring a similar level of
the protection and
(c) the parties in the transaction accept) all of the measurement result at that time and on
a given location.
The climatic environment
Climatic environments are the conditions in which you can gauge
to use. In order to take into account climatic differences between the
the Member States, has been defined by a series of temperature range.
Distribution company
A utility is regarded as a supplier of electricity,
gas, heat or water.
THE BASIC REQUIREMENTS
1. Allowable errors
1.1. Under rated operating conditions and without the occurrence of disturbance, the error of
measurement exceed the value of the maximum permissible errors (MPEs) set out in
the relevant requirements of the instrument.
If it is not in the specific annexes to this regulation for each of the
instrument provides otherwise, MPE is expressed as a bilateral
the value of the deviation from the true measurement value.
1.2. Under rated operating conditions and in the event of interference must
the requirement to comply with the relevant special requirements of the operation for
the type of gauge.
If the meter is intended for use in a specified permanent continuous
the electromagnetic field, must leave the measuring properties during
tests in high-frequency electromagnetic field emitted by a
metrological within the mpes.
1.3. The manufacturer shall specify the climatic, mechanical and electromagnetic
the environments in which the instrument used, power supply and other
influence quantities likely to affect its accuracy, taking
need to take into account the requirements laid down in the relevant specific annexes
of this regulation for the different types of gauges.
1.3.1 climatic environment
If it is not in the annexes 3 to 12, to this regulation provides otherwise, the
the manufacturer shall set the upper temperature limit and the lower temperature limit of the values
listed in table 1, indicating whether the meter is designed for humidity, when
which to condense, or moisture, in which condensation
does not occur, and also the intended location of the meter, that is, in
an open or a closed space.
Table 1
I----------------------------I-----------------------------------------------I
And even the limits of temperature and
I----------------------------I-----------I-----------I-----------I-----------I
Even the upper temperature limit and 30 ° c and 40 ° c and 55 ° c and 70 ° c and
I----------------------------I-----------I-----------I-----------I-----------I
And the lower temperature limit and 5 ° c and-10 ° c and-25 ° c and-40 ° c and
I----------------------------I-----------I-----------I-----------I-----------I
1.3.2.
and Mechanical environment) are divided into classes M1 to M3 as described below.
M1
This class applies to measuring instruments which are used in areas with
low vibration and shocks, especially on the gauge mounted to the lighter
supporting constructions, which are subject to negligible vibrations and
shock as a result of local activities related to waves,
gusts, pounding the door.
M2
This class covers the gauges to be used in areas with significant
or high levels of vibration and shock, especially of machinery and
passing vehicles in the vicinity or adjacent to heavy
machines, conveyor belts.
M3
This class covers the gauges to be used in areas where there is a high
or very high levels of vibration and shock, especially on the gauge mounted
directly on machines, conveyor belts.
(b)) in connection with the mechanical environment it is necessary to consider the following
influence quantities:
1. vibration,
2. mechanical impact.
1.3.3.
and in the applicable) specific annexes to this regulation for
each instrument provides otherwise, electromagnetic
environment into classes E1, E2, E3, as set out below.
E1
This class applies to measuring instruments which are used in areas with
the appropriate interference electromagnetic interference, which can be found in the
residential and commercial buildings, and buildings for light industry.
E2
This class covers the gauges to be used in areas with
the appropriate interference electromagnetic interference, which can be found in the
other industrial buildings.
E3
This class applies to measuring instruments which are powered by the battery of the vehicle.
This meter must meet the requirements of E2 and the following additional
requirements:
1. voltage reductions caused by energising the starter-motor circuits of internal
the incineration,
2. transition phenomena related to the disconnection of the load, which appear in the
When the engine is running is disconnected battery.
(b)) in relation to the electromagnetic environment is to be considered
the following influence quantities:
1. voltage interruptions,
2. short voltage reductions,
3. voltage transients on supply lines or on the lines
the signal,
4. electrostatic discharges,
5. radio frequency electromagnetic fields,
6. radio frequency electromagnetic fields on supply
lines and/or signal lines,
7. surges on supply lines and/or signal lines.
1.3.4 other influence quantities, which might need to be considered are
a) voltage fluctuations,
(b) variations in the frequency of the network)
c) magnetic fields of the network frequency,
(d)) any other quantity likely to influence in a significant way
the accuracy of the gauge.
1.4 on the carrying out of examinations under this regulation is subject to the following
points:
1.4.1. Basic rules for testing and the determination of errors
Essential requirements referred to in points 1.1 and 1.2 shall be verified for
each relevant influence quantity. If it is not in the appropriate specific
the annex to this regulation for the type of measuring instrument provides otherwise,
use these basic requirements if and only if each is affecting
quantity used by itself, and its effect is evaluated individually,
all other influence quantities remain relatively
constant at their reference values.
Metrological tests shall be carried out during or after their
influence quantity whichever condition corresponds to the
the normal operational status of the gauge when this influence quantity
may not take effect.
1.4.2. ambient Humidity
and according to the work of the climate) the environment in which the meter is to be
used, you can use either exam moist heat at constant temperature
(non-condensing) or damp heat cyclic (condensing).
(b) moist heat cyclic Test) is suitable, if there is a significant
condensation, or the penetration of water vapour is urychlováno the influence
breathing. Under the conditions of moisture, when there is no condensation, it is appropriate
test of moist heat at constant temperature.
2. Reproducibility
When you use the same measurand in a different location, or other
by the user, with all other terms and conditions remain the same, must be
the results of successive measurements. The difference between the
measurement results shall be small when compared with the MPE.
3. Repeatability
When you use the same measurand under the same conditions of measurement shall be
the results 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 must have for the intended measurement
a sufficiently low threshold and trailing.
5. stability
A measuring instrument shall be designed to maintain adequate stability
of its metrological characteristics over a period in advance by the manufacturer,
provided that it is properly installed, maintained and operated
in accordance with the manufacturer's instructions in the environmental conditions for which it is intended.
6. reliability
A measuring instrument shall be designed so as to minimize the impact as much as possible
a defect that would lead to an inaccurate measurement result, unless the
the existence of such a defect is obvious.
7. expiry date
7.1. A measuring instrument shall have no characteristics likely to facilitate the
fraudulent use, and the possibilities for unintentional misuse shall be
the minimum.
7.2. A measuring instrument shall be suitable for its intended use, taking
take account of the real conditions of work, and must not be placed on the user when
his quest to obtain the correct result on unreasonable claims.
7.3 media consumption meters in Error distribution network flow or
streams outside the reference range must not be unnecessarily unilateral.
7.4. If the meter is intended for the measurement of values of the measurand that
are constant over time, the measuring instrument shall be insensitive to small
fluctuations in the value of the measurand, or shall take appropriate action.
7.5. A measuring instrument shall be robust enough and the materials of which it is
designed, must satisfy the conditions in which it is used.
4.7 measuring instrument shall be designed so that after the placing on the market and putting into service
allow the control of the measuring functions. If required, must be part of
gauges and special equipment or software for this check.
The test procedure must be described in the operating instructions.
If the measuring instrument belongs to the software next to the measurement function
provides additional features, you must have software that is for
the metrological characteristics of a vital, identifiable and must not be
inadmissibly influenced by.
8. protection against distortion
8.1 the metrological characteristics of the meter may not be any undue
way affected by connecting another device to this gauge, no
the properties of the connected device or by any remote device that
the meter is communicating.
8.2 part of the technical equipment, which is critical for the metrological
the property must be designed so that it can be secured.
Designed security device must provide evidence of any intervention.
8.3 software that is critical for metrological characteristics,
must be identified as such and shall be secured.
Identify the software must allow the easy way
the gauge.
Evidence of any intervention must be available for a reasonable period of time.
8.4. Measured values, software that is critical for measurement
characteristics and metrologically important parameters stored or transmitted,
must be adequately protected against accidental or malicious
distortion.
5.3 media consumption for the gauges in the distribution network may not be possible during the
use the reset indication unit of the total of the quantities delivered or
the indicating unit, from which the total quantity supplied,
totally or in part, forms the basis of the statement, derive.
9. Information that is located on the gauge or accompanying it
9.1. A measuring instrument shall bear the following inscriptions:
and the name of the manufacturer), the trade name or mark,
(b) information about its accuracy) and, where appropriate:
(c)) information related to the conditions of use,
d) measuring ability,
(e)), the measuring range,
f) identification marking;
g) EU type-examination certificate number or certificate EU
examination of the design,
h) information on whether or not additional devices providing metrological
the results comply with the provisions of this regulation concerning metrology
checks or not.
5.7 Meter, whose dimensions are too small or have too soft
the construction, so that it could be placed in the appropriate information, you must have
adequate packaging, if the meter is packed, and the accompanying
the documentation required by the provisions of this regulation.
9.3 the measuring instrument shall be accompanied by information on its operation,
If the gauge is not so simple that this information is not needed.
Information must be easy to understand and must, if necessary,
contain
and working conditions)
b) mechanical and electromagnetic environment classes,
(c)) the upper and lower temperature limit, whether condensation may occur, or
Instead, open or closed spaces,
d) instructions for installation, maintenance, repairs, permissible adjustments,
e) instructions for correct operation and any special conditions of use and
f) the conditions for compatibility with interfaces, sub-assemblies or measuring instruments.
Groups of identical measuring instruments used (9.4) on the same site or for
measurement of supply in distribution network may not necessarily have separate instructions for
owner's manual.
9.5 unless in the relevant annex to this regulation for the type of
unless otherwise specified, the gauge scale interval for a measured value shall be in the
the form 1 x 10n, 2 x 10n or 5 x 10n, where n is any integer or
zero. The unit of measurement or its symbol shall be placed near
numeric values.
9.6. A material measure shall be marked with a nominal value or a scale
with the appropriate unit of measurement.
9.7 the units of measurement Used and their symbols shall be in accordance with the
the provisions of legislation regulating the use of units of measurement and
their brands.
9.8 all marks and inscriptions required under any requirement
must be clear, indelible, unambiguous and non-transferable.
10. Indication of result
10.1 the measurement result shall be indicated by the display or
the permanent record.
10.2 the indication of the measurement result shall be clear and unambiguous and
accompanied by such marks and inscriptions, which are necessary for
informing the user of the significance of the result. Under normal conditions,
the use of the result must be easy to read. May be given additional
indications, provided that it is not be confused with the metrologically
controlled indications.
10.3 in the event of permanent record printout or record must be also
easily readable and indelible.
10.4 a measuring instrument intended for direct sales trading transactions shall be
designed so that when the intended installation showed the result of measurement
both parties to the transaction. If it is in the case of direct sales essential
any ticket provided to the consumer by an ancillary
a device that does not meet the requirements of this regulation, include
for information on the limitations.
10.5 irrespective of whether the measuring instrument is intended for the measurement of supply in
the distribution of distance purposes or not, must be in each
the case is fitted with a metrologically controlled indicator unit which
It is accessible for the customer without the help of any tools. Reading this
display is the measurement result that serves as the basis for
the determination of the prices charged.
11. Further processing of data to conclude the trading transaction
11.1. A measuring instrument other than a gauge of consumption of media in the distribution network must
permanently record the measurement result accompanied by information that
is used to identify the transaction, if
the measurement is non-repeatable), and
b) gauge is normally intended to be used without the presence of one of the parties
business transactions.
11.2 in addition, shall, on request at the time of the completion of the measurement to
present continuous proof of the measurement result and the information that is used to
identify the transaction.
12. Conformity assessment
A measuring instrument shall be designed so as to allow for easy assessment of compliance with
the relevant requirements of this regulation.
Č. 2
THE CONFORMITY ASSESSMENT PROCEDURES
THE INTERNAL PRODUCTION CONTROL (MODULE A)
1. Internal production control is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3 and 4 and on their own responsibility
ensures and declares that the measuring instruments concerned satisfy the requirements of this
the regulation, which applies to them.
2. Technical documentation
The manufacturer shall establish the technical documentation described in § 12. Documentation
must enable the conformity of the instrument with the appropriate requirements, and
include an adequate analysis and assessment of risks. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the instrument.
3. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the technical documentation
referred to in point 2 and with the requirements of this regulation which apply to them.
4. the conformity marking and EU Declaration of conformity
4.1. The manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation.
4.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market, together with
the technical documentation at the disposal of the national authorities. IN THE EU
Declaration of conformity shall identify the instrument for which it was drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
shipment of the measuring instruments.
5. Authorized Representative
The manufacturer's obligations set out in point 4 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if they are listed in the
credentials.
INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM
INTERVALS (The A2)
1. Internal production control plus supervised instrument checks at random
intervals are the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3, 4 and 5 and on their own responsibility
ensures and declares that the measuring instruments concerned satisfy the requirements of this
the regulation, which applies to them.
2. Technical documentation
The manufacturer shall establish the technical documentation described in § 12. Documentation
must enable the conformity of the instrument with the appropriate requirements, and
include an adequate analysis and assessment of risks. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the instrument.
3. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the technical documentation
referred to in point 2 and with the requirements of the legislation which apply to them.
4. instrument checks
According to the manufacturer's choice, either an accredited in-house body or a
the notified body shall carry out or arrange to have such control of measuring instruments
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, to
technological complexity of the instruments and the quantity of production. Before placing the
on the market removes the body on the spot corresponding to the sample of the finished
gauges, shall be examined and appropriate tests
laid down in the relevant parts of the harmonised standards and/or normative
document or equivalent tests laid down in other relevant
the technical specifications in order to verify the conformity of the instruments with the appropriate
the requirements of this regulation. If such relevant harmonised standard
or normative document does not exist, it shall decide that an accredited
in-house body or a notified body, the appropriate tests to
they have to perform.
In cases where a certain number of instruments in the sample do not conform to an acceptable
quality level, the accredited in-house body or
the notified body must take appropriate measures.
If the tests are carried out by the notified body, the manufacturer during the manufacturing process
affix the identification number of the notified body.
5. the conformity marking and EU Declaration of conformity
5.1 the manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation.
5.2. the manufacturer shall draw up a written declaration of conformity for the EU model of the gauge and
for a period of 10 years after the gauge on the market together with the technical
documentation for the disposal of the national authorities. The EU Declaration
of conformity must be instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
6. Authorized Representative
The manufacturer's obligations set out in point 5 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if they are listed in the
credentials.
THE EU TYPE-EXAMINATION (MODULE B)
1. the EU type-examination is the part of a conformity assessment procedure in which
the notified body examines the technical design of a measuring instrument and validates and
confirms that the technical design of a measuring instrument satisfies the requirements of this
the regulation, which is applicable to it.
2. the EU type examination may be carried out by one of the following
methods:
and the sample of the complete measuring instrument), which is representative of the
the planned production (production type);
(b) the assessment of the suitability of the technical design) the gauge through
examination of the technical documentation and supporting evidence referred to in point 3 and
examination of one or more significant part of the essential parts of the measuring instrument
the representative for the production envisaged (combination of production type and
design type),
(c) the assessment of the suitability of the technical design) the gauge through
examination of the technical documentation and supporting evidence referred to in point 3 without
examination of the specimen (design type).
On the appropriate manner and the specimens required by the notified body shall decide.
3. the manufacturer lodges an application with a single notified body of his choice, the request
the EU type-examination.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) the technical documentation described in § 12. The technical documentation must
enable the conformity of the instrument with the appropriate requirements of this
Regulation and shall include an adequate analysis and assessment of risks. Technical
documentation shall specify the applicable requirements and to the extent necessary for the
the assessment must cover the design, manufacture and operation of the instrument.
The request must also contain, if applicable:
(d) samples representative of the planned) production. The notified body may
request further specimens if needed for the implementation of the programme
the tests,
(e) to establish the suitability of) the documents of the technical design solution. These
the supporting evidence shall mention any relevant documents that
have been applied, in particular where the relevant harmonised standards or
normative documents have not been applied in full. The supporting evidence
where necessary, the results of the tests carried out in accordance with the
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
for measuring instruments
4.1. examine the technical documentation and supporting evidence to assess the
adequacy of the technical design of a measuring instrument;
for the sample/samples
4.2 verifies whether the samples were manufactured in conformity with the technical documentation,
and identify the elements which have been designed in accordance with the applicable provisions of
relevant harmonised standards or normative documents, as well as
elements which have been designed in accordance with other relevant technical
specifications;
4.3. perform or have performed the appropriate examinations and tests in order to
check whether, where the manufacturer has chosen the solutions in the relevant
harmonised standards and normative documents, these standards and
documents applied correctly;
4.4. carry out or have carried out appropriate examinations and tests in order to
determine whether, in the case where the solution has been applied according to the relevant
the harmonized standards or normative documents, meet
other relevant technical specifications, by the manufacturer,
the corresponding essential requirements of this regulation;
4.5 agree with the manufacturer, at which point the examinations and tests
performed.
in other parts of the measuring instrument
4.6. 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
the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to the
obligations of the notified body to the authority for standards,
Metrology and testing (hereinafter referred to as "the Office") by the notified body
may disclose the contents of this report, in full or in part, only
with the consent of the manufacturer.
6. where the type meets the requirements of this regulation, the notified body
the producers of the EU type-examination certificate. This certificate must
contain the name and address of the manufacturer, conclusions of the examination, the conditions of
its validity and the necessary data for identification of the approved type.
The EU type-examination certificate can be attached to one or more of the
attachments.
The EU type-examination certificate and its annexes shall contain all
appropriate information to allow evaluation of whether they are produced in a gauge
conformity with the examined type and perform a check in operation. In order to be
possible to evaluate the conformity of the manufactured instruments with the examined type of
terms of their metrological performances of reprodukovateInosti, if
are properly adjusted using appropriate intended means to do so, you must
be included, in particular, the following information:
and the metrological characteristics of the type of measuring instrument),
(b)) the measures necessary for ensuring the integrity of the measuring instruments (sealing,
identification of software, etc.),
(c)) for information on other elements necessary for the identification of the instruments and
for Visual external conformity to type,
(d)) where appropriate, any specific information necessary to
Verify the characteristics of manufactured instruments,
(e)) for subreports with all necessary information to ensure the compatibility with
other sub-assemblies or measuring instruments.
The EU type-examination certificate is valid for a period of 10 years from the date of issue
and may be renewed for subsequent periods of 10 years.
If the type does not satisfy the relevant requirements of this regulation, the notified
body refuses to issue the EU type-examination certificate and shall inform the
applicant accordingly, giving detailed reasons for such denial denial.
7. the notified body shall ensure that it is kept informed of any changes
the generally acknowledged State of the art which indicate that the approved
type may no longer comply with the applicable requirements of this regulation, and
shall determine whether such changes require further investigation. If the investigation
require, the notified body shall inform the manufacturer.
8. The manufacturer shall inform the notified body that holds the technical
the documentation concerning the EU type-examination certificate of all
modifications to the approved type that may affect the conformity with the
the essential requirements of this regulation or the conditions for validity of the
the certificate. Such modifications require additional approval in the form of a supplement to the
the original EU type-examination certificate.
9. each notified body shall inform the authority of the EU type-examination certificates
type or additions thereto which it has issued or withdrawn, and shall, periodically or
on request, make available to the authority the list of these certificates or additions to
they refused, suspended or otherwise restricted.
The Commission, Member States and the other notified bodies may receive on request
a copy of the EU type-examination certificate and any additions thereto. The Commission and the Member
States may, on request, obtain a copy of the technical documentation and the results of the
the examination carried out by a notified body.
To the expiry of the EU type-examination certificate stores
the notified body must a copy of the certificate, its annexes and additions, as well as
as well as the technical file including the documentation submitted by the manufacturer.
10. For a period of 10 years after the gauge on the market, the manufacturer for
the national authorities a copy of the EU type-examination certificate,
its annexes and additions with the technical documentation.
11. the manufacturer's authorised representative may lodge the application referred to in point 3 and
to fulfil the obligations laid down in points 8 and 10, where they are listed in the
credentials.
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)
1. conformity to type based on internal production control is the part of the procedure
conformity assessment, 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
as described in the EU type-examination certificate and satisfy the requirements of this
the regulation, which applies to them.
2. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the approved type
as described in the EU type-examination certificate and with the requirements of this
the regulation, which applies to them.
3. the conformity marking and EU Declaration of conformity
3.1. the manufacturer shall affix the "CE" marking and the supplementary metrology marking
laid down in this regulation to each measuring instrument that is in
conformity with the type as described in the EU type-examination certificate and satisfies the
the relevant requirements of this regulation.
3.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
4. Authorized Representative
The manufacturer's obligations set out in point 3 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if they are listed in the
credentials.
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL AND INSPECTION OF MEASURING INSTRUMENTS
UNDER The SUPERVISION Of At Random Intervals (Module C2)
1. conformity to type based on internal production control and inspections
gauges under supervision at random intervals is the part of the procedure
conformity assessment, the manufacturer fulfils the obligations laid down in points 2,
3 and 4, and on its own responsibility, ensures and declares that the measuring instruments concerned
are in conformity with the type as described in the EU type-examination certificate and
meet the requirements of this regulation which apply to them.
2. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the type as described in the
the EU type-examination certificate and with the requirements of this regulation which is
to them.
3. instrument checks
According to the manufacturer's choice, either an accredited in-house body or a
a notified body chosen by the manufacturer shall carry out inspections of meters or leaves
such checks at random intervals, which itself
lays down, in order to verify the quality of the internal checks of the meter, with the
taking into account inter alia the technological complexity of the instruments and produced
quantity. Prior to launch, removes the on site by the notified body
the corresponding sample of the finished gauge, which shall be examined and
appropriate tests set out in the relevant parts of the
the harmonized standards or normative documents or equivalent
the tests prescribed in other relevant technical specifications
to check the conformity of the instrument with the type as described in the certificate of the EU
type-examination and with the relevant requirements of this regulation.
If the sample does not meet the acceptable quality level, the accredited
in-house body or a notified body the appropriate measures.
The procedure to determine the acceptable level of quality of the samples to be
used to determine whether the manufacturing process of the instrument in the
such limits, to ensure the conformity of the measuring instrument.
If the tests are carried out by the notified body, the manufacturer during the manufacturing process
affix the identification number of the notified body.
4. the conformity marking and EU Declaration of conformity
4.1. The manufacturer shall affix to each measuring instrument that is in conformity with the
type as described in the EU type-examination certificate and satisfies the applicable
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation.
4.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
5. Authorized Representative
The manufacturer's obligations set out in point 4 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if they are listed in the
credentials.
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
(MODULE D)
1. conformity to type based on quality assurance of the production process is
part of a conformity assessment procedure, the manufacturer fulfils the obligations
laid down in points 2 and 5, and ensures and on their own responsibility
declares that the measuring instruments concerned are in conformity with the type as described in the
the EU type-examination certificate and satisfy the requirements of this regulation,
that apply to them.
2. production
The manufacturer must operate an approved quality system for production, final inspection
the product and testing of measuring instruments referred to in point 3 and shall be subject to surveillance as specified in
point 4.
3. quality system
3.1. the manufacturer must lodge an application for assessment of his quality system for the
the gauge.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) all relevant information on gauge category envisaged,
(d)) the documentation concerning the quality system,
e) technical documentation of the approved type and a copy of the certificate of the EU
type-examination.
3.2. The quality system shall ensure compliance of the instruments with the type as described in the
the EU type-examination certificate and with the requirements of this regulation which is
to them.
All the elements, requirements and provisions adopted by the manufacturer must be
a systematic and orderly manner in the form of written policies,
procedures and instructions. This quality system documentation must permit a consistent
interpretation programmes, plans, manuals and records relating to quality.
It must contain in particular an adequate description of:
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to product quality,
(b)) to the respective techniques, processes and systematic actions that are
used in the manufacture, control and quality assurance,
(c)) the examination and tests that will be carried out before, during
and after manufacture, the frequency with which,
d) quality records, in particular of inspection reports and records of the
tests carried out, records of calibration reports
the qualifications of the personnel concerned,
e) means to monitor the achievement of the required quality
the product 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 3.2.
The elements of the quality system that comply with the relevant specifications
relevant harmonised standards, compliance with these requirements.
Persons who, on behalf of the notified body carrying out the assessment system
quality, (hereinafter referred to as "audit team") must have experience with systems
quality management and knowledge of the applicable requirements of this regulation and
at least one member with experience of evaluation in the relevant
the field of measuring instruments and appropriate technology. The audit includes an assessment
a visit to the manufacturer's premises.
Auditing team shall review the technical documentation referred to in point 3.1.
(a). (e)), to verify the manufacturer's ability to identify the relevant requirements of
of this regulation, and to perform the necessary examinations to ensure compliance
instrument with those requirements.
The conclusions of the audit, including the reasons therefor shall be notified to the manufacturer.
3.4. the manufacturer must undertake to fulfil the obligations arising from the
the quality system as approved and to maintain it so that it
remains adequate and efficient.
3.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system.
The notified body shall evaluate the proposed changes and decide whether the modified
the quality system will still satisfy the requirements referred to in 3.2, or
whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
4. supervision 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 for the purpose of assessment will allow the manufacturer to the notified body access to the
the places of manufacture, inspection, testing and storage, and shall provide the
it with all necessary information, in particular
and quality system documentation)
(b)) the quality records, in particular the reports of the inspections, the records from the
tests carried out, records of the performed calibration,
the qualifications of the personnel concerned,
4.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and shall provide the manufacturer detail about
audit.
4.4 in addition, the notified body may pay the manufacturer unannounced
visits. During such visits the notified body may
If necessary, carry out or have carried out tests to verify measuring instruments
whether the quality system is functioning correctly. The notified body must provide the manufacturer
with a visit report and, if tests have been carried out.
5. the conformity marking and EU Declaration of conformity
5.1 the manufacturer shall affix to each measuring instrument that is in conformity with the
type as described in the EU type-examination certificate and satisfies the applicable
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation, and the identification number of the notified
body referred to in point 3.1.
5.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
6. the manufacturer shall keep available for the national authorities for a period of 10 years from the
the placing on the market of the gauge:
and) the documentation referred to in point 3.1,
b) information about the change referred to in point 3.5, as approved;
(c)) the conclusions and reports of the notified body referred to in points 3.5, 4.3, and
4.4.
7. each notified body shall inform the Office of quality system approvals
which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority
the list of quality system approvals refused, suspended or otherwise
restricted.
8. Authorized Representative
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be
behalf and under his responsibility fulfilled by his authorised representative,
If they are specified in the mandate.
QUALITY ASSURANCE Of The PRODUCTION PROCESS (Module D1)
1. quality assurance of the production process is the assessment procedure
consensus, whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and on
own responsibility, ensures and declares that the measuring instruments concerned satisfy the
the requirements of this regulation which apply to them.
2. Technical documentation
The manufacturer shall establish the technical documentation described in § 12. Documentation
must enable the conformity of the instrument with the appropriate requirements, and
include an adequate analysis and assessment of risks. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the instrument.
3. the manufacturer shall keep the technical documentation at the disposal of the national
authorities for a period of 10 years after the meter on the market.
4. production
The manufacturer must operate an approved quality system for production, final inspection
the product and testing of the measuring instrument referred to in section 5 and shall be subject to surveillance as specified in
section 6.
5. quality system
5.1. the manufacturer must lodge with the notified body of his choice, the request for
assessment of his quality system for the gauge.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) all relevant information on gauge category envisaged,
(d)) the documentation concerning the quality system,
e) technical documentation referred to in point 2.
5.2. The quality system shall ensure compliance of the instruments with the requirements of this
the regulation, which applies to them.
All the elements, requirements and provisions adopted by the manufacturer must be
a systematic and orderly manner in the form of written policies,
procedures and instructions. This quality system documentation must permit a consistent
interpretation programmes, plans, manuals and records relating to quality.
Must contain in particular an adequate description of the
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to product quality,
(b)) to the respective techniques, processes and systematic actions that are
used in the manufacture, control and quality assurance,
(c)) the examination and tests that will be carried out before, during
and after manufacture, the frequency with which,
d) quality records, such as inspection reports and records of the
tests carried out, records of calibration reports
the qualifications of the personnel concerned,
(e)) the means of monitoring the achievement of the required quality
the product and the effective operation of the quality system.
5.3. the notified body must assess the quality system to determine whether it satisfies
the requirements referred to in point 5.2.
The elements of the quality system that comply with the relevant specifications
relevant harmonised standards, compliance with these requirements.
The auditing team must have experience in quality management systems and knowledge
the relevant requirements of this regulation and at least one Member must
with experience of evaluation in the relevant area of the gauges and the competent
technology. The audit includes an assessment visit to the premises of the
manufacturer.
Auditing team shall review the technical documentation referred to in point 2,
Verify the manufacturer's ability to identify the relevant requirements of this regulation
and perform the necessary examinations to ensure compliance of the instrument with the following
requirements.
The conclusions of the audit, including the reasons therefor shall be notified to the manufacturer.
5.4. the manufacturer shall undertake to fulfil the obligations arising out of the
the quality system as approved and to maintain it so that it
remains adequate and efficient.
5.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system.
The notified body shall evaluate the proposed changes and decide whether the modified
the quality system will still satisfy the requirements referred to in point 5.2 or
whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
6. the Supervision 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 in order to allow the assessment of the manufacturer to the notified body access to the
the places of manufacture, inspection, testing and storage, and shall provide the
it with all necessary information, in particular
and quality system documentation)
(b)) the technical documentation referred to in point 2,
(c)) the quality records, in particular the reports of the inspections, the records from the
tests carried out, records of the performed calibration,
the qualifications of the staff concerned.
6.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and shall provide a report on the
audit.
6.4 in addition, the notified body may pay the manufacturer unannounced
visits. During such visits the notified body may
If necessary, carry out or have carried out tests to verify measuring instruments
whether the quality system is functioning correctly. The notified body must provide the manufacturer
with a visit report and, if tests have been carried out.
7. the conformity marking and EU Declaration of conformity
7.1. The manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation, and the identification number of the notified
body referred to in point 5.1.
7.2. The manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it was drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
8. the manufacturer shall keep available for the national authorities for a period of 10 years from the
the placing on the market of a measuring instrument
and) the documentation referred to in point 5.1,
b) information about the change referred to in paragraph 5.5, as approved,
(c)) the conclusions and reports of the notified body referred to in points 5.5, 6.3 and
6.4.
9. each notified body shall inform the Office of quality system approvals,
which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority
the list of quality system approvals refused, suspended or otherwise
restricted.
10. Authorized Representative
The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be his
behalf and under his responsibility fulfilled by his authorised representative,
If they are specified in the mandate.
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE GAUGE (MODULE E)
1. conformity to type based on quality assurance of the measuring instruments is part of the
conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in
paragraphs 2 and 5 and on his own responsibility, ensures and declares that the
gauges are in conformity with the type as described in the EU type-examination certificate
type and meet the requirements of this regulation which apply to them.
2. production
The manufacturer must operate an approved quality system for final product inspection
the test gauges as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. quality system
3.1. the manufacturer lodges an application with a notified body of his choice, the request for
assessment of his quality system for the gauge.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) all relevant information on gauge category envisaged,
(d)) the documentation concerning the quality system,
e) technical documentation of the approved type and a copy of the certificate of the EU
type-examination.
3.2. The quality system shall ensure compliance of the instruments with the type as described in the
the EU type-examination certificate and with the appropriate requirements of this
of the regulation.
All the elements, requirements and provisions adopted by the manufacturer must be
a systematic and orderly manner in the form of written policies,
procedures and instructions. This quality system documentation must permit a consistent
interpretation programmes, plans, manuals and records relating to quality.
Must contain in particular an adequate description of the
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to product quality,
(b)) the examination and tests that will be carried out after manufacture,
(c)) the quality records, in particular of inspection reports and records of the
tests carried out, records of calibration reports
the qualifications of the personnel concerned,
(d)) the means of monitoring the efficient operation of the system
the quality.
3.3 the notified body shall assess the quality system to determine whether it satisfies
the requirements referred to in 3.2.
The elements of the quality system that comply with the relevant specifications
relevant harmonised standards, compliance with these requirements.
The auditing team must have experience in quality management systems and knowledge
the relevant requirements of this regulation and at least one Member must
with experience of evaluation in the relevant area of the gauges and the competent
technology. The audit includes an assessment visit to the premises of the
manufacturer.
Auditing team shall review the technical documentation referred to in point 3.1.
(a). (e)), to verify the manufacturer's ability to identify the relevant requirements of
of this regulation, and to perform the necessary examinations to ensure compliance
instrument with those requirements.
The conclusions of the audit, including the reasons therefor shall be notified to the manufacturer.
3.4. the manufacturer must undertake to fulfil the obligations arising from the
the quality system as approved and to maintain it so that it
remains adequate and efficient.
3.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system.
The notified body shall evaluate the proposed changes and decide whether the modified
the quality system will still satisfy the requirements referred to in 3.2, or
whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
4. supervision 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 for the purpose of assessment will allow the manufacturer to the notified body access to the
the places of manufacture, inspection, testing and storage, and shall provide the
it with all necessary information, in particular:
and quality system documentation)
(b)) the quality records, in particular the reports of the inspections, the records from the
tests carried out, records of the performed calibration,
the qualifications of the staff concerned.
4.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and shall provide the manufacturer detail about
audit.
4.4 in addition, the notified body may pay the manufacturer unannounced
visits. During such visits the notified body may
If necessary, carry out or have carried out tests to verify measuring instruments
whether the quality system is functioning correctly. The notified body must provide the manufacturer
with a visit report and, if tests have been carried out.
5. the conformity marking and EU Declaration of conformity
5.1 the manufacturer shall affix to each measuring instrument that is in conformity with the
type as described in the EU type-examination certificate and satisfies the applicable
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation, and the identification number of the notified
body referred to in point 3.1.
5.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
6. the manufacturer shall keep available for the national authorities for a period of 10 years from the
the placing on the market of the gauge:
and) the documentation referred to in point 3.1,
b) information about the change referred to in point 3.5, as approved,
(c)) the conclusions and reports of the notified body referred to in points 3.5,
4.3 and 4.4.
7. each notified body shall inform the Office of quality system approvals,
which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority
the list of quality system approvals refused, suspended or otherwise
restricted.
8. Authorized Representative
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be
behalf and under his responsibility fulfilled by his authorised representative,
If they are specified in the mandate.
QUALITY ASSURANCE Of FINAL Instrument Inspection And Testing (Module E1)
1. Quality assurance of final inspection and testing of the measuring instruments is
the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in
paragraphs 2, 4 and 7, and on its own responsibility, ensures and declares that the
measuring instruments meet the requirements of this regulation which apply to them.
2. Technical documentation
The manufacturer shall establish the technical documentation described in § 12. Documentation
must enable the conformity of the instrument with the appropriate requirements, and
include an adequate analysis and assessment of risks. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the instrument.
3. the manufacturer shall keep the technical documentation at the disposal of the competent
the national authorities for 10 years after the meter on the market.
4. production
The manufacturer must operate an approved quality system for final product inspection
and tests of measuring instruments in accordance with section 5 and shall be subject to surveillance as specified in point 6.
5. quality system
5.1. the manufacturer must lodge with the notified body of his choice, the request
assessment of his quality system for the gauge.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) all relevant information on gauge category envisaged,
(d)) the documentation concerning the quality system,
e) technical documentation referred to in point 2.
5.2. The quality system shall ensure compliance of the instruments with the requirements of this
the regulation, which applies to them.
All the elements, requirements and provisions adopted by the manufacturer must be
a systematic and orderly manner in the form of written policies,
procedures and instructions. This quality system documentation must permit a consistent
interpretation programmes, plans, manuals and records relating to quality.
It must contain in particular an adequate description of:
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to product quality,
(b)) the examination and tests that will be carried out after manufacture,
(c)) the quality records, in particular of inspection reports and records of the
tests carried out, records of calibration reports
the qualifications of the personnel concerned,
(d)) the means of monitoring the efficient operation of the system
the quality.
5.3. the notified body must assess the quality system to determine whether it satisfies
the requirements referred to in point 5.2.
The elements of the quality system that comply with the relevant specifications
relevant harmonised standards, compliance with these requirements.
The auditing team must have experience in quality management systems and
knowledge of the applicable requirements of this regulation and at least one
Member must have experience of evaluation in the relevant field of measuring instruments and
the appropriate technology. The audit includes an assessment visit to the premises of the
the premises of the manufacturer.
Auditing team shall review the technical documentation referred to in point 2,
Verify the manufacturer's ability to identify the relevant requirements of this regulation
and perform the necessary examinations to ensure compliance of the instrument with the following
requirements.
The conclusions of the audit, including the reasons therefor shall be notified to the manufacturer.
5.4. the manufacturer shall undertake to fulfil the obligations arising out of the
the quality system as approved and to maintain it so that it
remains adequate and efficient.
5.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system.
The notified body shall evaluate any proposed changes and decide whether the
modified quality system will still satisfy the requirements referred to in section 5.2,
or whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
6. the Supervision 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 in order to allow the assessment of the manufacturer to the notified body access to the
the places of manufacture, inspection, testing and storage, and shall provide the
it with all necessary information, in particular:
and quality system documentation)
(b)) the technical documentation referred to in point 2,
(c)) the quality records, in particular the reports of the inspections, the records from the
tests carried out, records of the performed calibration,
the qualifications of the staff concerned.
6.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and shall provide the manufacturer detail about
audit.
6.4 in addition, the notified body may pay the manufacturer unannounced
visits. During such visits the notified body may
If necessary, carry out or have carried out tests to verify measuring instruments
whether the quality system is functioning correctly. The notified body must provide the manufacturer
with a visit report and, if tests have been carried out.
7. the conformity marking and EU Declaration of conformity
7.1. The manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation, and the identification number of the notified
body referred to in point 5.1.
7.2. The manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
8. the manufacturer shall keep available for the national authorities for a period of 10 years from the
the placing on the market of a measuring instrument
and) the documentation referred to in point 5.1,
b) information about the change referred to in paragraph 5.5, as approved,
(c)) the conclusions and reports of the notified body referred to in points 5.5, 6.3 and
6.4.
9. each notified body shall inform the Office of quality system approvals
which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority
the list of quality system approvals refused, suspended or otherwise
restricted.
10. Authorized Representative
The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be his
behalf and under his responsibility fulfilled by his authorised representative,
If they are specified in the mandate.
CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION (MODULE F)
1. conformity to type based on product verification is the part of the procedure
conformity assessment, the manufacturer fulfils the obligations laid down in points 2,
5.1 and 6 and on its own responsibility, ensures and declares that the
the gauge, which has been subject to the procedure referred to in point 3 are in conformity with the type
as described in the EU type-examination certificate and satisfy the requirements of this
the regulation, which applies to them.
2. production
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
as described in the EU type-examination certificate and with the requirements of this
the regulation, which applies to them.
3. verification of the
A notified body chosen by the manufacturer, shall carry out or have carried out
the appropriate examinations and tests in order to check the conformity of the instruments with the approved
type as described in the EU type-examination certificate and with the relevant
the requirements of this regulation.
The examinations and tests to verify the conformity of the instruments with the appropriate requirements of
According to the manufacturer's choice be carried out either by examination and testing of every
instrument as specified in point 4 or by examination and testing of the measuring instruments on the
statistical basis as specified in point 5.
4. verification of conformity by examination and testing of every instrument.
4.1 all measuring instruments shall be individually examined and must be carried out
the appropriate tests as set out in the relevant harmonised standards
or normative documents or equivalent tests pursuant to other
relevant technical specifications in order to verify compliance with the
approved type described in the EU type-examination certificate and with the
the relevant requirements of this regulation.
If a harmonised standard or normative document does not exist, shall decide
the notified body concerned, the appropriate tests to be carried out.
4.2. the notified body shall issue a certificate of conformity with regard to the carried out
examinations and tests and each approved instrument or have it
own responsibility, affix its identification number.
The manufacturer shall keep the certificates of conformity available for inspection by
the national authorities for 10 years after the meter on the market.
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 series produced, and shall present his
measuring instruments for verification in the form of homogeneous lots.
5.2 from each series are randomly according to the requirements of section 5.3 removes
sample. All measuring instruments in the sample shall be individually examined and
appropriate tests set out in the relevant harmonised
standards or normative documents, technical specifications or
equivalent tests pursuant to other relevant technical specifications
to check the conformity of the instruments with the type as described in the certificate of the EU
type-examination and with the relevant requirements of this regulation and
to determine whether the lot is accepted or rejected. If such
harmonised standard or normative document does not exist, it shall decide the
the notified body, the appropriate tests to be carried out.
5.3. The statistical procedure shall meet the following requirements:
Statistical control will be based on functional characteristics.
The sampling system shall ensure:
and the level of quality corresponding to a probability) acceptance of 95%, with a share
-conformity of less than 1%,
(b) limit quality corresponding to a probability) of acceptance of 5%, with the share
-conformity of less than 7%.
5.4. If a lot is accepted, all measuring instruments shall be considered in the series for
In addition to the approved measuring instruments from the sample that were recorded
non-compliant test results.
The notified body shall issue a certificate of conformity with regard to the carried out
examinations and tests and each approved instrument or have it
affix its identification number.
The manufacturer shall keep the certificates of conformity available for the national authorities
period of 10 years from putting a meter on the market.
5.5 If a lot is rejected, the notified body shall take appropriate measures to ensure that
avoid putting this series on the market. In the event of frequent rejection of lots
the notified body may suspend the statistical verification and take
the appropriate measures.
6. the conformity marking and EU Declaration of conformity
6.1. The manufacturer shall affix to each measuring instrument that is in conformity with the
approved type described in the EU type-examination certificate and satisfies the
the relevant requirements of this regulation, the CE marking and supplementary
Metrology marking laid down in this regulation and the identification number
the notified body referred to in point 3.
6.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the Declaration of conformity on request to the authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
If the notified body referred to in point 3 agrees, the manufacturer may
affix the notified body's identification number to the measuring instruments.
7. If the notified body agrees, the manufacturer may affix the gauge
the notified body's identification number during the manufacturing process.
8. Authorized Representative
The manufacturer's obligations may be on his behalf and under his responsibility fulfilled
his authorised representative, if they are specified in the mandate.
Authorised representative may not fulfil the obligations laid down in points manufacturer
2 and 5.1.
CONFORMITY BASED On PRODUCT VERIFICATION (Module F1)
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
own responsibility, ensures and declares that the measuring instruments concerned, which was
subject to the procedure referred to in point 4, is in conformity with the requirements of this
the regulation, which applies to them.
2. Technical documentation
The manufacturer shall establish the technical documentation described in § 12. Documentation
must enable the conformity of the instrument with the appropriate requirements, and
include an adequate analysis and assessment of risks. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the instrument.
The manufacturer shall keep the technical documentation at the disposal of the competent
the national authorities for 10 years after the meter on the market.
3. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the appropriate requirements of
of this regulation.
4. verification of the
A notified body chosen by the manufacturer, shall carry out or have carried out
the appropriate examinations and tests in order to check the conformity of the instruments with the appropriate
the requirements of this regulation.
The examinations and tests to check the conformity with these requirements in accordance with
the manufacturer's choice be carried out either by examination and testing of every instrument
According to section 5, or by examination and testing of the measuring instruments on the statistical
basis as specified in point 6.
5. verification of conformity by examination and testing of every instrument.
5.1 Each gauge shall be individually examined and appropriate
tests as set out in the relevant harmonised standards or
normative documents or equivalent tests referred to in other
relevant technical specifications in order to verify the conformity of the instruments with the
the requirements that apply to them. Such a harmonised standard
or normative document does not exist, the notified body concerned shall decide
the appropriate tests to be carried out.
5.2. the notified body shall issue a certificate of conformity with regard to the carried out
examinations and tests and each approved instrument or have it
affix its identification number.
The manufacturer shall keep the certificates of conformity available for the national authorities
period of 10 years from putting a meter on the market.
6. Statistical verification of conformity.
6.1 the manufacturer shall take all measures necessary in order that the manufacturing process
ensures the homogeneity of each produced the series, and presents his measuring instruments for
verification in the form of homogeneous batches.
6.2 from each series are randomly according to the requirements of section 6.4 removes
sample.
6.3 all measuring instruments in the sample shall be individually examined and must be carried out
the appropriate tests as set out in the relevant harmonised standards
or normative documents or equivalent tests pursuant to other
relevant technical specifications in order to check the conformity of these
measuring instruments with the requirements of this regulation, and to decide whether it will be a series of
accepted or rejected. Such a harmonised standard, or
There is no normative document, the notified body concerned shall decide which
appropriate tests to be carried out.
6.4. The statistical procedure shall meet the following requirements:
Statistical control will be based on functional characteristics.
The sampling system shall ensure:
and the level of quality corresponding to a probability) acceptance of 95%, with a share
-conformity of less than 1%,
(b) limit quality corresponding to a probability) of acceptance of 5%, with the share
-conformity of less than 7%.
6.5 If a lot is accepted, all measuring instruments shall be considered in the series for
In addition to the approved measuring instruments from the sample that were recorded
non-compliant test results.
The notified body shall issue a certificate of conformity with regard to the carried out
examinations and tests and each approved instrument or have it
affix its identification number.
The manufacturer shall keep the certificates of conformity available for the national authorities
period of 10 years from putting a meter on the market.
If a lot is rejected, the notified body shall take appropriate measures to ensure that
avoid putting this series on the market. In the event of frequent rejection of lots
the notified body may suspend the statistical verification and take
the appropriate measures.
7. the conformity marking and EU Declaration of conformity
7.1. The manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation, and the identification number of the notified
body referred to in point 4.
7.2. The manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
disposal of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
If the notified body referred to in point 5 agrees, the manufacturer may
affix the notified body's identification number to the measuring instruments.
8. If the notified body agrees, the manufacturer may affix the gauge
the notified body's identification number during the manufacturing process.
9. Authorized Representative
The manufacturer's obligations may be on his behalf and under his responsibility fulfilled
his authorised representative, if they are specified in the mandate.
Authorised representative may not fulfil the obligations laid down in point 2, the manufacturer
the first paragraph, point (3) and section 6.1.
CONFORMITY BASED ON UNIT VERIFICATION (MODULE G)
1. conformity based on unit verification is the procedure
conformity assessment, whereby the manufacturer fulfils the obligations laid down in points 2,
3 and 5, and on its own responsibility, ensures and declares that the measuring instrument,
that has undergone the procedure as specified in point 4, is in conformity with the requirements of this
the regulation, which applies to them.
2. Technical documentation
The manufacturer shall establish the technical documentation described in § 12 and give it to the
available to the notified body referred to in point 4. The documentation must
enable the conformity of the instrument with the appropriate requirements, and contain
adequate analysis and risk assessment. The technical documentation must
specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the instrument.
The manufacturer shall keep the technical documentation at the disposal of the competent
the national authorities for 10 years after the meter on the market.
3. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instrument with the appropriate requirements of
of this regulation.
4. verification of the
A notified body chosen by the manufacturer, shall carry out or have carried out
appropriate examinations and tests as set out in the relevant
harmonised standards or normative documents or equivalent
the tests referred to in other relevant technical specifications, to
Verify the conformity of the instrument with the appropriate requirements of this regulation. If
such a harmonised standard or normative document does not exist, shall decide
the notified body concerned, the appropriate tests to be carried out.
The notified body shall issue a certificate of conformity with regard to the carried out
examinations and tests and approved instrument or have it affixed
its identification number.
The manufacturer shall keep the certificates of conformity available for the national authorities
period of 10 years from putting a meter on the market.
5. the conformity marking and EU Declaration of conformity
5.1 the manufacturer shall affix to each measuring instrument that satisfies the appropriate requirements of
of this regulation, the CE marking and supplementary metrology marking
laid down in this regulation and the identification number of the notified body
referred to in point 4.
5.2. the manufacturer shall draw up a written declaration of conformity and the EU for a period of 10 years from the
the placing on the market of the gauge is at the disposal of the national authorities. In
EU Declaration of conformity shall identify the instrument for which it was
drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity is supplied with the meter.
6. Authorized Representative
The manufacturer's obligations set out in points 2 and 5 may be on its behalf and on
his responsibility fulfilled by his authorised representative, if they are
specified in the mandate.
CONFORMITY BASED ON FULL QUALITY ASSURANCE (MODULE H)
1. conformity based on full quality assurance is the procedure
conformity assessment, whereby the manufacturer fulfils the obligations laid down in points 2 and
5 and on his own responsibility, ensures and declares that the measuring instruments concerned
meet the requirements of this regulation which apply to them.
2. production
The manufacturer must operate an approved quality system for design, manufacture,
final inspection and testing of the measuring instruments referred to in point 3 and shall be subject to
surveillance as specified in point 4.
3. quality system
3.1. the manufacturer lodges an application with a notified body of his choice, the request for
assessment of his quality system for the gauge.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) the technical documentation described in § 12 for one model of each
categories of measuring instruments, which are to be produced. The documentation must allow
assessment of the conformity of the instrument with the appropriate requirements, and contain
adequate analysis and risk assessment. The technical documentation must
specify the applicable requirements and to the extent necessary for the assessment,
cover 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
of the notified body.
3.2. The quality system shall ensure compliance of the instruments with the requirements of this
the regulation, which applies to them.
All the elements, requirements and provisions adopted by the manufacturer must be
a systematic and orderly manner in the form of written policies,
procedures and instructions. This quality system documentation must permit a
uniform interpretation programmes, plans, manuals and records relating to the
the quality.
Must contain in particular an adequate description of the
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to the quality of the design and measuring instruments
(b)) technical design specifications, including standards, that will be used, and
in the case that the relevant harmonised standards and/or normative
the documents do not apply in full, the means that are
apply, in order to ensure compliance with the essential requirements of this
the regulation, which will apply on the gauge, with the use of other relevant
technical specifications;
c) inspection and design verification techniques, processes and systematic
the activities that will be used when designing the instruments that belong to the
the appropriate category measuring instruments
(d)) of the respective techniques, processes and systematic actions that are
used in the manufacture, control and quality assurance,
(e)) of the examination and tests that will be carried out before, during
and after manufacture, the frequency with which,
(f)) the quality records, in particular of inspection reports and records of the
tests carried out, records of calibration reports
the qualifications of the personnel concerned,
g) the means of monitoring the achievement of the required quality
the design and the product 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 3.2.
The elements of the quality system that comply with the relevant specifications
relevant harmonised standards, compliance with these requirements.
The auditing team must have experience in quality management systems and knowledge
the relevant requirements of this regulation and at least one Member must
with experience of evaluation in the relevant area of the gauges and the competent
technology. The audit includes an assessment visit to the premises of the
manufacturer.
Auditing team shall review the technical documentation referred to in point 3.1.
(a). (b)), to verify the manufacturer's ability to identify the relevant requirements of
of this regulation, and to perform the necessary examinations to ensure compliance
instrument with those requirements.
The conclusions of the audit, including the reasons therefor shall be communicated to the manufacturer or its
authorised representative.
3.4. the manufacturer must undertake to fulfil the obligations arising from the
the quality system as approved and to maintain it so that it
remains adequate and efficient.
3.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system.
The notified body shall evaluate the proposed changes and decide whether the modified
the quality system will still satisfy the requirements referred to in 3.2, or
whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
4. supervision 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 for the purpose of assessment will allow the manufacturer to the notified body access to the
the places of design, manufacture, inspection, testing and storage
and shall provide it with all necessary information, in particular:
and quality system documentation)
(b)) the quality records provided for in part of the quality system relating to
the design, in particular the results of analyses, calculations, tests,
(c)) the quality records provided for in the manufacturing part of the quality system, in particular the
reports of inspections, the records of the tests carried out, records from the
the performed calibration, qualification reports of the personnel concerned.
4.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and shall provide the manufacturer detail about
audit.
4.4 in addition, the notified body may pay the manufacturer unannounced
visits. During such visits the notified body may
If necessary, carry out or have carried out tests of measuring instruments, to
Verify that the quality system is functioning correctly. The notified body shall
the manufacturer with a visit report and, if tests have been
performed.
5. the conformity marking and EU Declaration of conformity
5.1 the manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking, the supplementary metrology marking
laid down in this regulation and the identification number of the notified body
referred to in point 3.1.
5.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
the needs of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
6. the manufacturer shall keep available for the national authorities for a period of 10 years from the
the placing on the market of a measuring instrument
and) the technical documentation referred to in point 3.1,
(b)) the documentation concerning the quality system referred to in point 3.1,
c) information about the change referred to in point 3.5, as approved;
(d)) the conclusions and reports of the notified body referred to in points 3.5, 4.3, and
4.4.
7. each notified body shall inform the Office of quality system approvals,
which it has issued or withdrawn, and shall, periodically or upon request, make available to the authority
the list of quality system approvals refused, suspended or otherwise
restricted.
8. Authorized Representative
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be
behalf and under his responsibility fulfilled by his authorised representative,
If they are specified in the mandate.
CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
(Module H1)
1. conformity based on full quality assurance plus design examination
is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down
in paragraphs 2 and 6, and on its own responsibility, ensures and declares that the
measuring instruments meet the requirements of this regulation which apply to them.
2. production
The manufacturer must operate an approved quality system for design, manufacture,
final inspection and testing of the measuring instrument referred to in point 3 and shall be subject to
surveillance as specified in point 5. The adequacy of the technical design of the measuring instruments must be
examined under point 4.
3. quality system
3.1. the manufacturer lodges an application with a notified body of his choice, the request for
assessment of the quality system for the gauge.
The application must include
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) all relevant information on gauge category envisaged,
(c)) the documentation concerning the quality system,
(d)) a written declaration that the same application has not been lodged with any other
of the notified body.
3.2. The quality system shall ensure compliance of the instruments with the requirements of this
the regulation, which applies to them.
All the elements, requirements and provisions adopted by the manufacturer must be
a systematic and orderly manner in the form of written policies,
procedures and instructions. This quality system documentation must permit a consistent
interpretation programmes, plans, manuals and records relating to quality.
Must contain in particular an adequate description of the
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to the quality of the design and measuring instruments
(b)) technical design specifications, including standards, that will be used, and
in the case that the relevant harmonised standards and/or normative
the documents do not apply in full, the means that are
apply, in order to ensure compliance with the essential requirements of this
the regulation, which will apply on the gauge, with the use of other relevant
technical specifications,
c) inspection and design verification techniques, processes and systematic actions
that will be used when designing the gauges, which belongs to the competent
categories of measuring instruments,
(d)) of the respective techniques, processes and systematic actions that are
used in the manufacture, control and quality assurance,
(e)) of the examination and tests that will be carried out before, during
and after manufacture, the frequency with which,
(f)) the quality records, in particular of inspection reports and records of the
tests carried out, records of calibration reports
the qualifications of the personnel concerned,
g) the means of monitoring the achievement of the required quality
design and measuring instruments 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 3.2. The elements of the quality system that conform to the
the relevant specifications of the relevant harmonised standards, compliance with these
the requirements of the standard.
The auditing team must have experience in quality management systems and knowledge
the relevant requirements of this regulation and at least one Member must
with experience of evaluation in the relevant area of the gauges and the competent
technology. The audit includes an assessment visit to the premises of the
manufacturer.
The conclusions of the audit, including the reasons therefor shall be communicated to the manufacturer or its
authorised representative.
3.4. the manufacturer must undertake to fulfil the obligations arising from the
the quality system as approved and to maintain it so that it
remains adequate and efficient.
3.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system.
The notified body shall evaluate the proposed changes and decide whether the modified
the quality system will still satisfy the requirements referred to in 3.2, or
whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
3.6. Each notified body shall inform the authority of approvals
the quality which it has issued or withdrawn, and shall, periodically or upon request, the
The Office of the list of quality system approvals refused, suspended or
otherwise restricted.
4. Design examination
4.1. the manufacturer must lodge an application for examination of the design with the notified body
referred to in point 3.1.
4.2. the application shall enable understanding of the design, manufacture and operation of the instrument
and shall enable assessment of conformity with the requirements of this regulation which is
to them.
The application must include:
and) the name and address of the manufacturer,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) the technical documentation described in § 12. The documentation must allow
assessment of the conformity of the instrument with the appropriate requirements, and contain
adequate analysis and risk assessment. To the extent necessary for this
the assessment includes the design and operation of the instrument,
(d) supporting evidence for the adequacy of) the technical design. This supporting
the evidence shall mention any documents that have been applied, in particular where the
relevant harmonised standards or normative documents have not been used
to the fullest extent, and if necessary, include the results of the tests
carry out appropriate laboratory of the manufacturer, or by another testing laboratory on his
behalf and under his responsibility with the use of other appropriate technical
specifications.
4.3. the notified body shall examine the application and where the design meets the requirements of
of this regulation, that the instrument shall issue a certificate to the manufacturer
The EU review of the proposal. The certificate must contain the name and address of the
the manufacturer, conclusions of the examination, conditions for its validity and the data
necessary for identification of the approved design. The certificate may be
one or more annexes attached.
The certificate and its annexes shall contain all relevant information
to allow evaluation of whether they are produced in accordance with the measuring instruments
přezkoumaným design, and to control traffic. Must allow
the conformity of the manufactured instruments with the proposal from the perspective of přezkoumaným
the reproducibility of their metrological functions when they are properly
adjusted using appropriate intended means, and shall include:
and the metrological characteristics of the design of a measuring instrument),
(b)) the measures necessary for ensuring the integrity of the measuring instruments (sealing,
identification of software, etc.),
(c)) for information on other elements necessary for the identification of the instruments and
for Visual external conformity to the design,
(d)) where appropriate, any specific information necessary to
Verify the characteristics of manufactured instruments,
(e)) for subreports with all necessary information to ensure the compatibility with
other sub-assemblies or measuring instruments.
The notified body shall draw up an assessment report and stores it for
the needs of the supervisory authorities. Without prejudice to the provisions of § 23 para. 1
the law, the notified body may disclose the contents of this report, in full
the range, or in part, only with the consent of the manufacturer.
The certificate is valid for 10 years from the date of issue and may be
renewed for subsequent periods of 10 years.
If the design does not meet the relevant requirements of this regulation, the notified
body refuses to issue EU design examination certificate and shall inform the
applicant accordingly, giving detailed reasons for such denial denial.
4.4. the notified body shall ensure that it is kept informed of any changes
the generally acknowledged State of the art which indicate that the approved
the proposal may no longer be in compliance with the relevant requirements of this regulation,
and shall determine whether such changes require further investigation. If the investigation
require, the notified body shall inform the manufacturer.
The manufacturer shall inform the notified body that has issued certificate of EU
examination of the design of all modifications to the approved design that may
affect the conformity of a measuring instrument with the essential requirements of this regulation or
conditions for validity of the certificate. These modifications to the notified body,
which issued the design examination certificate of the EU require additional approval in the form of
addition to the original EU design examination certificate.
4.5 each notified body shall inform the authority of EU certificates
design review and any additions thereto which it has issued, or
withdrawn, and shall, periodically or upon request, make available to the Office a list of certificates
and any additions thereto refused, suspended or otherwise restricted.
The Commission, the Member States and the other notified bodies may, on request of the
receive a copy of EU design examination certificates and/or any additions thereto.
The Commission and the Member States may, on request, obtain a copy of the technical
documentation and the results of the review carried out by the notified body.
To the expiry of the EU design examination certificate stores
the notified body must a copy of the certificate, its annexes and additions to
him, as well as the technical file including the documentation
submitted by the manufacturer.
4.6 for a period of 10 years after the gauge on the market, the manufacturer for
a copy of the disposal of the national authorities of the EU design examination certificate,
its annexes and additions with the technical documentation.
5. the Supervision 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 for the purpose of assessment will allow the manufacturer to the notified body access to the
the places of design, manufacture, inspection, testing and storage
and shall provide it with all necessary information, in particular
and quality system documentation)
(b)) the quality records provided for in part of the quality system relating to
the design, in particular the results of analyses, calculations, tests,
(c)) the quality records provided for in the manufacturing part of the quality system, in particular the
reports of inspections, the records of the tests carried out, records from the
the performed calibration, qualification reports of the personnel concerned.
5.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and shall provide the manufacturer detail about
audit.
5.4. In addition, the notified body may pay the manufacturer unannounced
visits. During such visits the notified body may
If necessary, carry out or have carried out tests of measuring instruments, to
Verify that the quality system is functioning correctly. The notified body shall
the manufacturer with a visit report and, if tests have been
performed.
6. the conformity marking and EU Declaration of conformity
6.1. The manufacturer shall affix to each measuring instrument that satisfies the appropriate
the requirements of this regulation, the CE marking and supplementary metrology
the designations provided for in this regulation, and the identification number of the notified
body referred to in point 3.1.
6.2. the manufacturer shall draw up a written EU Declaration of conformity for each model
the gauge and for a period of 10 years after the gauge on the market is a must, for
the needs of the national authorities. The EU Declaration of conformity must be reported
instrument model, for which it has been drawn up, and also the number of the certificate
a review of the proposal.
A copy of the EU Declaration of conformity at the request of the supervisory authorities.
A copy of the EU Declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. In the case that the user supplies a greater number of 1
measuring instruments can be supplied a copy of the EU Declaration of conformity for the entire series or
the shipment of the measuring instruments.
7. the manufacturer shall keep available for the national authorities for a period of 10 years from the
the placing on the market of a measuring instrument
and) documentation concerning the quality system referred to in point 3.1,
b) information about the change referred to in point 3.5, as approved;
(c)) the conclusions and reports of the notified body referred to in points 3.5, 5.3 and
5.4.
8. Authorized Representative
Manufacturer's authorised representative may lodge the application referred to in points 4.1 and
4.2 and on behalf of the manufacturer and its responsibility to fulfil the obligations laid down in
paragraphs 3.1, 3.5, 4.4, 4.6, 6 and 7, if they are specified in the mandate.
Č. 3
Water meters (MI-001)
To water meters intended for the measurement of volumes of clean, cold or heated water when
use in residential, commercial and light industry are subject to
the requirements set out in annex 1 to this regulation and the specific
requirements and the conformity assessment procedures listed in this annex.
The DEFINITION of the
Water meter
A measuring instrument designed to measure, memorise and display the volume of water
flowing through the measurement transducer for measuring conditions.
Minimum flowrate (Q1)
The lowest flowrate at which the water meter provides indications that satisfy the
requirements for the maximum permissible errors (MPEs).
The transitional flowrate (Q2)
The transitional flowrate is the value that lies between the permanent and minimum
flow and which the flowrate range is divided into two zones, the "upper zone" and the
"lower zone". For each band are some of the MPE.
Permanent flowrate (Q3)
The highest flowrate at which the meter operates in a satisfactory manner for the
normal conditions of use, i.e. under steady or variable
conditions of flow.
Overload flowrate (Q4)
The overload flowrate is the highest flowrate at which the meter works
in a satisfactory manner for a short period of time without deteriorating.
SPECIAL REQUIREMENTS
Rated operating conditions
The manufacturer shall specify the rated operating to gauge conditions, in particular:
1. the scope of water flow
The values for the flowrate range shall fulfil the following conditions:
Q3/Q1 > = 40
Q2/Q1 = 1.6
Q4/Q3 = 1.25
2. The range of temperature of water
The values for the temperature range shall fulfil the following conditions:
from 0.1 ° c to at least 30 ° c, or
from 30 ° c to at least 90 ° c.
The meter can be designed to work in both ranges.
3. the relative pressure Range of the water: this range is in Q3 from 0.3 bars to
at least 10 bars.
4. For the power supply: the nominal value of the AC voltage supply
or the limits of DC supply voltage.
Maximum permissible error (MPE)
5. The MPE, positive or negative, on volumes of proteklých when the flow in the range of
from the transition of the flow (Q2) (included) to the přetěžovacího flow rate (Q4) is
2% for water having a temperature 30 ° c, < =
3% for water having a temperature 30 ° c >.
The water meter must be no abuses of the MPE, nor to the systematic
favour one of the parties
6. The MPE, positive or negative, on volumes at the flows in the proteklých
the range of minimum flowrate (Q1) to transition the flow (Q2)
(except) is 5% for water of any temperature.
The water meter must be no abuses of the MPE, nor to the systematic
favour one of the parties.
Permissible effect of disturbances
7.1. Electromagnetic immunity
7.1.1 electromagnetic interference may affect the meter only to the extent that the
and) change measurement result is no greater than the critical change value
as defined in section 7.1.3, or
(b)) the indication of the measurement result is such that it is not possible to
interpreted as a valid result, but as the instantaneous fluctuation, that cannot be
interpreted, memorised or passed as a result of the measurement.
7.1.2 After exposure to electromagnetic disturbance the water meter shall
and restore their activity in) between the MPE,
(b)) to ensure all measurement functions safeguarded, and
(c) allow the recovery of all) the measured values available immediately
prior to disturbance.
7.1.3. The critical change value corresponds to the smaller value of the two
the following values:
and the volume corresponding to half the size) of the MPE in the upper zone on the measured
the volume,
(b)) the volume corresponding to the MPE for the volume delivered in one minute at
flowrate Q3.
7.2 Stability
After an appropriate test, taking into account the time taken
the duration of the time estimated by the manufacturer, the following must be true
criteria:
7.2.1 the fluctuation of the measurement result after the durability test, due to the
initial measurement result, shall not exceed
a) 3% of the metered volume between Q1 included and Q2 excluded;
b) 1.5% of the metered volume between Q2 included and Q4 included.
7.2.2. The error of indication of the volume measured after the durability test,
must not be greater than the
a) +-6% of the metered volume between Q1 included and Q2 excluded;
(b)) +-2.5% of the metered volume between Q2 included and Q4 included for
water meters intended to meter water with a temperature between 0.1 ° c and 30 ° c,
(c)) +-3.5% of the metered volume between Q2 included and Q4 included for
water meters intended to meter water with a temperature between 30 ° c and 90 ° c.
The applicability of the
8.1 the meter must be able to be installed to operate in any
position, unless clearly indicated otherwise.
5.1 the manufacturer shall specify whether the meter is designed to measure reverse flow. In
this case, the volume of reverse flow either to be deducted from the total
volume, or shall be recorded separately. For supply and reverse
the flow must pay the same MPE.
Water meters not designed to measure reverse flow shall either
back flow prevent, or reverse flow must withstand random without
damage or changes to metrological properties.
The unit of measurement
9. The measured volume shall be indicated in cubic metres.
Putting into operation
10. it must be ensured that the requirements referred to in points 1, 2 and 3 were
distribution company or by a person designated for installing the meter
set so that the meter is appropriate for the accurate measurement of the expected
or foreseeable consumption.
CONFORMITY ASSESSMENT
The conformity assessment procedures referred to in paragraph 10, that the manufacturer can choose
they are:
Module B + F module or module B + D or H1 module module.
Č. 4
Gas meters and VOLUME CONVERSION DEVICES (MI-002)
To gas meters and volume conversion devices defined below intended
for use in residential, commercial and light industry are subject to
the requirements set out in annex 1 to this regulation and the specific
requirements and the conformity assessment procedures listed in this annex.
The DEFINITION of the
The gas meter
A measuring instrument designed to measure, memorise and display the quantity (volume
or weight) of fuel gas, which it flowed.
Volume
A device attached 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 to the greatest permissible error (MPE).
Maximum flowrate (Qmax)
The highest flowrate at which the gas meter provides indications that satisfy the
requirements for MPE.
Transitional flowrate (Qt)
The transitional flowrate is the value that lies between the maximum and minimum
flow and which the flowrate range is divided into two zones, the "upper zone" and the
"lower zone". For each band are some of the MPE.
Overload flowrate (Qr)
The overload flowrate is the highest flowrate at which the meter works
a short period of time without deteriorating.
Basic conditions
The specified conditions to which the measured quantity of fluid is converted.
PART I
SPECIAL REQUIREMENTS
GAS METERS
1. Rated operating conditions
The manufacturer shall specify the rated operating conditions of the meter, taking
into account the following aspects:
1.1. The flowrate range of the gas shall fulfil at least the following conditions:
I----------------I-------------------I-------------------I-------------------I
(I) Class I/Qmin And Qmax-Qmax/Qr/Qmax Qt And I
I----------------I-------------------I-------------------I-------------------I
Even 1.5 I = 150 and > > = 10 and 1.2 and
I----------------I-------------------I-------------------I-------------------I
I even > 1.0 = 20 I = 5 and > 1.2 and
I----------------I-------------------I-------------------I-------------------I
1.2. gas temperature range: the minimum range is 40 ° c.
1.3. Terms applicable to fuel/gas
The gas meter shall be designed for the range of gases and pressures that input
correspond to the country of destination. The manufacturer must indicate, in particular,
and the group or type of gas),
(b)) 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
the DC supply voltage.
2. The maximum permissible errors (MPEs)
2.1 the gas meter indicating the volume at metering conditions or mass
Table 1
I------------------------------------I-------------------I-------------------I
(I) class I and 1.0 and 1.5
I------------------------------------I-------------------I-------------------I
I = Q, Qmin < < Qt and 3% and 2% and
I------------------------------------I-------------------I-------------------I
And Qt = Q = < Qmax and 1.5