Key Benefits:
Industry Minister,
In view of Directive 2004 /22/EC of the European Parliament and Council of 31 March 2004 on measuring instruments;
Given the amended Decree No. 61-501 of 3 May 1961 on units of measurement and control of measuring instruments;
Having regard to Decree No. 2001-387 of 3 May 2001 as amended, In particular by Decree No. 2006-447 of 12 April 2006 concerning the control of measuring instruments, together with the decree of 31 December 2001 adopted for its application;
Having regard to Decree No. 2006-447 of 12 April 2006 concerning the placing on the market and the Implementing certain measuring instruments, including items 1, 2, 6, 7, 8, 10, 16 and 19,
Stop:
For the purpose of the April 12, 2006 decree, the following means:
a) " Instrument of measurement ", any device or system having a measurement function defined in one of the MI-01 to MI-10 Annexes to this Order;
(b)" Subset ", a hardware device referred to as such in the annexes to this Order, which operates independently while constituting a measuring instrument, when this device is:
-or associated with other subsets With which it is compatible;
-is associated with a measuring instrument with which it is compatible;
c) " Manufacturer ", the natural or legal person who assumes responsibility for the conformity of the instrument of measurement to the decree of 12 April 2006 referred to above for the purpose of placing it on the market under its own name or putting into service for its own purposes ;
d) " Placing on the market ", the operation of making available for the first time an instrument intended for a final user, whether for compensation or for free;
e)" Commissioning ", the first use of an instrument intended for an end user for its intended purpose;
(f)" Agent ", the natural or legal person established in the Community and a manufacturer authorised, in writing, to act on his behalf for specific tasks within the meaning of the provisions of the decree of 12 April 2006 referred to
. This order, the term: " Instrument " Means measuring instruments and sub-sets of measurement instruments defined as such
The essential requirements referred to in Article 2 of the decree of 12 April 2006 referred to above are set out in Annex I to this Order in respect of the general requirements and the annexes MI-01 MI-10 for specific requirements according to the category to which the instruments belong.
The Conformity assessment procedures applicable to each category of instruments are indicated in each of the Annexes MI-01 to MI-10 in this Order, in the form of a combination of two conformity assessment modules or one. The procedures for the application of the conformity assessment modules are set out in Annexes A to H1 of this Order.
The technical documentation referred to in Article 7 of the decree of 12 April 2006 must be sufficiently detailed to ensure:
-the definition of metrological characteristics;
-the reproducibility of performance Metrology of the instruments manufactured when properly adjusted using the means provided;
-the integrity of the instruments.
It includes:
a) A general description of the measuring instrument;
b) Design plans And manufacturing, as well as schematics of components, subassemblies, circuits, etc. ;
(c) A description of the manufacturing processes that ensure the homogeneity of production;
(d) Where applicable, a description of electrical, electronic or computer devices incorporating drawings, diagrams, logigrams and General information on the characteristics and operation of the software components;
e) The descriptions and explanations necessary for the understanding of points b, c and d above, including those relating to the operation of The instrument;
f) A list of harmonised standards or normative documents applied in whole or in part giving presumption of conformity;
g) A description of the solutions adopted to meet the essential requirements applicable When harmonised standards or normative documents have not been applied;
h) The results of design calculations, checks carried out, etc. ;
i) If necessary, the results of the appropriate tests demonstrating that the type or instrument satisfies:
-the applicable requirements under assigned operating conditions and when exposed to environmental perturbations Specified;
-the durability criteria specified for water, gas, and thermal energy meters or liquid measuring assemblies other than water;
j) Test reports, CE examination certificates of type or CE certificates of design for instruments that are composed of elements identical to those used in the new instrument.
The manufacturer specifies the seals and markings that it has affixed. It specifies, if applicable, compatibility conditions for interfaces and subsets
CE marking shall be constituted by the symbol " THIS " In accordance with the format set out in Annex II to this Order. It has a size of at least 5 mm.
Additional metrological marking shall be constituted by the capital letter " M " And the last two digits of the year of its apposition, surrounded by a rectangle. The height of the rectangle is equal to the height of the CE marking. The additional metrological marking immediately follows the CE marking.
If the conformity assessment procedure The identification number of the notified body concerned shall be affixed after the conformity marking. This identification number must be indelible or destroyed when removed. It must also be clearly visible or easily accessible.
When a measuring instrument is made up of several Devices which are not sub-assemblies and which work together, the marks are affixed to the main device.
When a measuring instrument is too small or too sensitive to carry the conformity marking, it is On the packaging, if any, and on the documentation accompanying it, as required by Annex I to this Order
Manufacturers' quality assurance systems, which meet the criteria defined in the relevant parts of the NF EN ISO 9001 standard approved on 20 November 2000 or a standard defining equivalent requirements, and which meet the specifications of the metrological control, shall be presumed to meet the corresponding conditions mentioned in this Decree.
The quality assurance system of a manufacturer whose means of production are established outside the national territory, Can be approved on the same basis as quality assurance systems covering domestic productions
Organizations that meet the criteria defined in the standards listed in Annex III to this Order or to standards providing equivalent assurance of competence, and Comply with the specifications of the metrological control, are presumed to comply with the corresponding conditions referred to in Article 36 of the aforementioned Decree of 3 May 2001 and Article 37 of the Decree of 31 December 2001.
Notified bodies responsible for issuing certificates validating the design of an instrument inform the sub-directorate Responsible for the legal metrology of certificates issued, including any additives or modifications, or certificates withdrawn, under conditions specified by this sub-directorate. Information concerning withdrawals shall be communicated without delay.
These notified bodies shall provide the information necessary for the performance of the metrological controls available to other designated or approved bodies, free of charge. They shall also make such information available to other Member States and bodies notified by the other Member States under the same conditions.
Notified bodies responsible for issuing certificates validating the quality assurance system of a manufacturer shall inform the sub-directorate of the legal metrology of the List of quality assurance system approvals issued, denied or withdrawn under conditions specified by this sub-directorate. Information concerning withdrawals shall be communicated without delay.
These notified bodies shall make such information available to the other Member States and to bodies notified by other Member States, free of charge.
Notified bodies must have procedures to inform the legal metrology sub-directorate without delay Withdrawals referred to in sections 11 and 12.
They communicate to the legal metrology sub-directorate, upon express request, the evaluation reports of measurement instruments or quality assurance
. Also have procedures in place for the manufacturer to remedy the deficiencies as soon as possible if the supervision of a quality assurance system shows that the system no longer meets the conditions under which it was approved, or If the instruments manufactured are found to be non-compliant.
If, in accordance with the second paragraph of Article 7 of the Decree of 12 April 2006, the notified body responsible for conformity assessment accepts documents in a language other than French, but must nevertheless be able to provide the national authorities responsible for legal metrology Any information in French necessary for the exercise of the supervision of the organization.
The organization may issue translations, in a language other than French, of the documents it issues as part of the conformity assessment.
When multiple accuracy classes are defined for a A class of measuring instruments, measuring instruments belonging to a more demanding accuracy class than the one required can be used.
Where the regulation for the control of instruments in service provides that the instruments must be accompanied by a metrological log, it is not necessarily provided by the manufacturer of The instrument.
In addition, where it provides that the instruments are covered by a control mark in service, the first mark of that control may be affixed to the instrument without further testing by the notified body or the manufacturer Of the instrument, on the occasion of the attestation of conformity operations provided for in accordance with the abovementioned Directive of 31 March 2004. In such a case, the notified bodies or manufacturers shall use a sticker in accordance with the model set out in the Annex to the Decree of 31 December 2001, but with an identification of their choice, which must not, however, cause confusion with any Mark of auditor or repairman. They shall inform the sub-directorate responsible for legal metrology in France of the identification selected.
This provision does not imply that the manufacturer or the notified body is authorised or designated for the verification involving the affixing of the Mark of control in service.
Where the possibilities for affixing the first control mark in service presented above have not been used, the device shall be marked with that first mark not later than one month after its Put into service. At the request of the holder or seller of the instrument, the regional management of the industry, the research and the environment of the place of installation of the instrument will provide this mark free of charge or additional tests. However, it may request to consult or receive a copy of the declaration of conformity relating to the instrument concerned.
Without prejudice to Article 22 and, where appropriate, the last paragraph of Article 20 of the Decree of 12 April 2006, the following texts are repealed:
-Order of 29 December 1954 concerning construction and Approval of the types of electrical energy meters;
-dated December 30, 1954, as amended relating to the original verification of new electrical energy meters;
-Amended January 18, 1956, relating to construction, the Verification and use of the measuring instruments of liquid fuels, fuels and lubricants;
-Order of 5 August 1957 concerning the construction, verification and use of measuring instruments of liquid foodstuffs ;
-adopted on 15 January 1960 concerning the study of instruments which determine the volume of liquids other than water by means of systems without a petty chamber;
-adopted on 20 April 1961 on the study of the Gas mass meters;
-Order of July 26, 1961, concerning mass meters of liquids other than water;
-Order of May 12, 1972, relating to the construction, verification and use of meter-metering assemblies Turbine for measuring the volume of liquids other than water;
-dated 23 August 1973 relating to the construction, verification and use of temperature compensating devices associated with volume meters of liquids other than water Water;
-Order of 20 November 1973 concerning the application of ECE requirements for the control of volumetric meters of liquids other than water and their complementary devices;
-Order of 23 October 1974 as amended Relating to the construction, installation and verification of gas volume meters;
-Order of 28 July 1976 relating to the construction, verification and use of continuous totalizing weighing instruments on carrier Tape;
-Order of 3 February 1977 relating to the construction and verification of length measurements;
-Order of 29 April 1977 submitting the instruments for the thermal installations to reduce air pollution And to save energy in the study of the service of measuring instruments;
-order of 5 September 1977 relating to the weights;
-Decree of 29 September 1977 concerning construction, model approval, primitive verification And the use of thermal energy meters;
-adopted on June 19, 1978, as amended on the application of ECE requirements to the control of volumetric meter metering assemblies for measuring the volume of liquids other than That the water;
-Amended September 24, 1979, relating to the construction, the EEC type approval and the ECE primitive verification of electrical energy meters;
-Order of 17 February 1981 relating to construction, use And the verification of automatic weight sorting machines for the metrological control of prepackages;
-dated 14 December 1982 relating to construction, model approval and primitive verification of hot water meters ;
-Order dated January 6, 1987 relating to the construction and approval of the type of electric energy meters based on the principle of electronic energy measurement;
-order of August 5, 1987 relating to the correction sets of Volume of gas;
-dated 5 August 1987 relating to electronic computers integrated in a type 2 gas volume correction set;
-Order dated 24 April 1989 relating to the dimensions of the mouths of device pistols Gasoline dispensers;
-Order dated December 30, 1991 relating to the control of automatic weighing devices: discontinuous totalizing devices;
-Order of March 19, 1998, relating to certain weighing devices Automatic: - labellers;
-issued on 5 August 1998 relating to certain automatic weighing instruments: weight measurements;
-instructions V and VI of 19 December 1839 on the manufacture and verification of Capacity measures for liquids.
Without prejudice to Article 22 of the aforementioned decree of 12 April 2006, the Provisions of the following texts relating to the placing on the market and the placing in service of the instruments are no longer applicable:
-Order of 19 July 1976 on construction, model approval and primitive verification of the Cold water meters, as it relates to meters for metering in residential, commercial or light industrial settings;
-dated August 21, 1980, as amended relating to construction, model approval, installation and The initial verification of the taximeters, as it relates to the device before installation in the vehicle;
-adopted on 5 August 1987 relating to static pressure transducers integrated into a voludepreseter or in a set of Type 2 gas volume correction, as it relates to fuel gas volume conversion devices for light metering in residential, commercial or light industrial settings;
-order of 17 February 1988 laying down conditions Construction, approval and installation specific to electronic taximeters, as it relates to the device before installation in the vehicle;
-dated 22 November 1996 relating to the construction and control of analysers Exhaust gas from engines;
-order of 28 June 2002 laying down certain rules for the metrological control of liquid measuring sets other than water, subject to the following reservation;
-Order of 11 July 2003 fixing certain The terms of the metrological control of gas volume conversion sets and voludepressant pressure gauges, as it relates to fuel gas volume conversion devices for residential, commercial or residential measurement
However, the verification of the installation provided for in accordance with the order of 28 June 2002 mentioned above remains applicable until 31 December 2009 when the measuring sets consist of elements making The subject of a type examination certificate or a valid UNECE model approval certificate within the limits defined in Article 22 of the decree of 12 April 2006 mentioned above.
The Director of Regional Action, Quality and Industrial Security is responsible for the execution of this Order, which will be published in the Official Gazette of the Republic French.
A N N E X E I
GENERAL ESSENTIAL REQUIREMENTS
An instrument of Measure must ensure a high level of metrological protection so that any party affected by the measurement can have confidence in its outcome. Its design and manufacture must be of a high quality with respect to metrological technology and the safety of measurement data.
The requirements to be met by the measuring instruments to ensure that these Objectives can be achieved are described below and are supplemented, where appropriate, by specific requirements in Annexes MI-01 to MI-10 to this Order, which describe in more detail certain aspects of the general
. Solutions adopted with regard to the requirements shall take into account the intended use of the device and any foreseeable abuse.
The instruments are presumed to comply with the applicable tests provided for in point i of Article 4 of the present Arrested when the corresponding testing program was conducted in accordance with the relevant documents referred to in section 3 of the April 12, 2006, Order-in-Council, and the results of the tests demonstrate compliance with the essential requirements.
Definitions
Mesurande:
A particular size that is subject to measurement.
Influence Grandeur:
Grandeur that is not the measurement, but that has an effect on the measurement result.
Conditions Assigned function:
Values that constitute the normal operating conditions of an instrument for the measurement and influence sizes.
Disturbance:
Influence size whose value is within the limits Specified in the applicable requirement, but outside the specified operating conditions specified for the measuring instrument.
A magnitude of influence is a disturbance if, for this magnitude of influence, the conditions assigned to Operation is not specified.
Critical change:
The value from which the variation of the measurement result is considered undesirable.
Materialized measure:
A device intended to reproduce or provide Constant during use one or more known values of a given quantity.
Direct selling:
Business transaction that meets the following conditions:
-the result of the measurement is the basis for the price to be paid, and
-au Less than one of the parties involved in the metering transaction is a consumer or any other party requiring a similar level of protection, and
-all parties interested in the transaction accept the result of the
Climate environments:
Conditions under which measurement instruments can be used.
Public utility service:
Electricity, gas, thermal, or electricity provider
Requirements
1. Tolerated Errors
1.1. In the assigned operating conditions and in the absence of disturbance, the measurement error shall not exceed the maximum tolerated errors (EMT) as defined in the specific requirements applicable to the instrument.
Except Indication to the contrary specified in the requirements for the different instruments, the EMTs are expressed in addition and at least symmetrically in relation to the true value.
1.2. For an instrument operating in the presence of a disturbance, the performance requirement is defined at the level of the specific requirements applicable to the instrument.
Where the device is intended for use in a field The permissible performance during the radiated electromagnetic field test, amplitude modulated, must be within the limits defined by the EMTs.
1.3. The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, the electrical supply, and the other influence sizes liable to affect its accuracy, in Taking into account the specific requirements for the device.
1.3.1. Climate Environments:
The manufacturer must specify the maximum and minimum temperatures chosen from the values shown in Table 1, unless otherwise disposed of in the specific requirements, and indicate whether The device is designed for moisture with or without condensation, and the nature of the intended place of use for the device, that is, open or closed.
Table 1
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1.3.2. Mechanical environments:
a) Mechanical environments are divided between the M1 to M3 classes defined below:
M1: this class applies to instruments used in locations exposed to vibrations and shocks For example, for instruments fixed on light bearing structures subjected to vibration and negligible impact due to local percussions or works, doors that clatter.
M2: this class applies to Instruments used in places exposed to a non-negligible or high level of vibration and shock, for example those transmitted by machinery and vehicles in the vicinity or those transmitted by heavy machinery, carriers to
M3: this class applies to instruments used in places where the level of vibration and shock is high and very high, for example for instruments mounted directly on machines, bands Carrier.
b) In conjunction with the mechanical environments, the following influence sizes must be considered:
-vibrations;
-mechanical shocks.
1.3.3. Electromagnetic environments:
(a) Electromagnetic environments are distributed between the following E1, E2 and E3 classes, unless otherwise specified in the specific device requirements.
E1: This class applies to instruments used in places where electromagnetic disturbances are consistent with those found in residential, commercial or light industry buildings.
E2: this class Applies to instruments used in places where electromagnetic disturbances correspond to those found in other industrial buildings.
E3: this class applies to instruments powered by the battery Of a vehicle. These instruments shall comply with the requirements formulated for class E2 and for the following additional influence sizes:
-decrease in the supply voltage caused by the boot of the engine starter circuits at Internal combustion;
-transient loss of charge that occurs when an uncharged battery is disconnected while the engine rotates.
b) In conjunction with electromagnetic environments, the following influence sizes Must be taken into account:
-power outages;
-brief voltage drops;
-voltage transient on power lines or signal lines;
-electrostatic discharges;
-fields Radiated electromagnetic frequencies;
-electromagnetic fields at radio frequencies that induce disturbances on the power lines or signal lines;
-shock waves on the Power lines or signal lines.
1.3.4. The other influence sizes to be taken into account, if any, are:
-changes in the power supply voltage;
-frequency variation;
-industrial frequency magnetic fields ;
-any other size that can have a significant influence on the accuracy of the device.
1.4. When performing the tests planned to verify the conformity of the instruments, the following points apply:
1.4.1. Basic rules for testing and error determination:
The essential requirements specified in 1.1 and 1.2 must be verified for each relevant quantity of influence. Unless otherwise provided in the specific requirements of an instrument, these essential requirements shall apply when each size of influence is applied and its effect evaluated separately, all other influence sizes Being maintained relatively constant at their reference value.
The metrological test shall be carried out during or after the application of the influence quantity, depending on the situation which corresponds to the normal state of operation of the The device when this size of influence is likely to occur.
1.4.2. Ambient humidity:
Depending on the climatic environment in which the instrument is intended to be used, the wet heat test under established regime (without condensation) or the test under cyclic wet heat (with condensation) can Be appropriate.
The cyclic wet heat test is appropriate in the event of significant condensation or when vapour penetration is accelerated by the effect of respiration. In the case of moisture without condensation, the wet heat test under established regime is appropriate.
2. Reproducibility
In case of application of the same measure in a different place or by a different user, all other conditions being identical, the results of successive measurements must be very close One another. The difference between the measurement results must be small relative to the EMT.
3. Repeatability
In the case of application of the same measure under identical measuring conditions, the results of successive measurements must be very close to each other. The difference between the measurement results must be small relative to the EMT.
4. Mobility and Sensitivity
The measurement instrument must be sensitive enough and have a mobility threshold low enough for the intended measurement.
5. Sustainability
A measuring device must be designed to maintain adequate constancy of its metrological characteristics for a period evaluated by the manufacturer, when properly installed, maintained, and Used in accordance with the manufacturer's instructions, when found in the environmental conditions to which it is intended.
6. Reliability
A measuring instrument must be designed so that it best reduces the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.
7. Dating
7.1. The measuring instrument should not have a characteristic that would facilitate fraudulent use; the potential for unintentional misuse must be minimized.
7.2. A measuring instrument shall be suitable for the use for which it is intended, taking into account the practical operating conditions, and shall not impose undue requirements on the user to obtain a measurement result
7.3. The errors of a measuring instrument intended for a utility service shall not be unduly biased, at rates or currents outside the controlled extent.
7.4. When a measuring instrument is designed to measure the values of a measure that are constant over time, the measuring instrument must either be insensitive to small fluctuations in the value of this measurand, or react in a manner that is
7.5. A measuring instrument must be robust and the materials with which it is constructed must be suitable for the intended use conditions.
7.6. A measuring instrument shall be designed in such a way as to enable the monitoring of the measuring functions after the instrument has been placed on the market and put into service. If necessary, special equipment or software for this control must be integrated into the device. The test procedure shall then be described in the user manual.
Where the software of a measuring instrument performs other functions other than that of measurement, the part of the software that is essential for the characteristics and Metrological performance must be identifiable and cannot be adversely affected by the other associated software.
8. Protection against corruption
8.1. The metrological characteristics of the measuring instrument shall not be unduly influenced by the connection to another device, by any characteristic of the connected device or by a device at Distance that communicates with the measuring instrument.
8.2. A material component which is essential for metrological characteristics and performance must be designed in such a way that it can be rendered inviolable. The intended security features shall make any intervention obvious.
8.3. The software which is essential for the metrological characteristics and performance must be identified as such and rendered inviolable. The identification of the software must be easily delivered by the measuring instrument. The evidence of an intervention must be available for a reasonable period of time.
8.4. Measurement data, the software that is essential for metrological characteristics and parameters memorized or transmitted and important from the metrological point of view must be sufficiently protected against accidental corruption or Intentional.
8.5. In the case of measuring instruments used by public utilities, the display of the total quantity delivered or the displays used to calculate the total delivered quantity, to which reference is made in whole or in part for Establish payment, should not be allowed to be reset in use.
9. Information that the device must be
and must accompany it
9.1. An instrument of measurement shall bear the following entries:
-the manufacturer's mark or name;
-information about its accuracy.
In addition, if applicable,
-relevant information about the Conditions of use;
-the metering capacity;
-the measurement range;
-an identity marking;
-the CE examination certificate number or the CE test certificate of the design;
-information Whether the additional devices delivering metrological results meet the legal metrology control provisions.
9.2. When an instrument has too small dimensions or is too sensitive to carry the required information, the packaging, if it exists, and the accompanying documents in accordance with the requirements must be marked in a manner
9.3. The instrument must be accompanied by information relating to its operation, unless its simplicity makes this information unnecessary. The information must be easily understandable and include, where applicable:
-the assigned operating conditions;
-mechanical and electromagnetic environment classes;
-maximum temperatures and Minimum for which it is approved, and indications of whether or not condensation is authorized and whether it can be used in an open or closed place;
-instructions for installation, maintenance, repairs and Allowable adjustments;
-instructions for its correct use and any special conditions of use;
-compatibility conditions with interfaces, subsets, or instruments Measure.
9.4. In the case of groups of identical measuring instruments used in the same place or measurement instruments used for utilities, individual user manuals are not necessarily required.
9.5. Unless otherwise specified in the specific requirements of an instrument, the level of indication of a measured value shall be in the form 1 x 10n, 2 x 10n, or 5 x 10n, where n is an integer or zero.
The unit of measurement or its Symbol must be specified near the numeric value.
9.6. A materialized measure must bear the nominal value or a scale with the unit of measurement.
9.7. Without prejudice to the provisions of the aforementioned decree of 3 May 1961, the units of measure used and their symbol shall comply with the Community provisions on units of measurement and
. All marks and markings required under a requirement must be clear, ineffable, unambiguous and non-transferable.
9.9. To the extent that this is necessary for the correct use of the instrument, the information that it carries or accompanying it must be provided in French.
10. Specify the result
10.1. The result must be displayed by display or as a printed copy.
10.2. The indication of any result must be clear and unambiguous; it must be accompanied by the marks and inscriptions necessary to inform the user of the meaning of the result. Under normal conditions of use, the indicated result must be easily legible. Additional indications may be available provided that they are not confusing with the indications controlled for metrology.
10.3. In the case of printed results, the printed copy must be easily legible and ineffable.
10.4. A measurement instrument for direct sale must be designed in such a way that, when installed as intended, it indicates the result of the measurement to the two parties involved in the transaction. Where this is of decisive importance in the context of direct sales, any ticket supplied to the consumer by means of an additional device which does not comply with the applicable requirements must bear the restrictive indications
10.5. Whether or not it is possible to remotely read a measuring instrument intended for measurement in the field of utility services, the instrument must in any event be equipped with a display device controlled for metrology, Accessible to the user without tools. The results from this display are used as the basis for determining the price to be paid.
11. Further processing
data to conclude the business transaction
11.1. A measuring instrument other than those intended for public utilities shall record by a sustainable means the result of the measurement, together with information to identify the transaction in question, where:
-the measurement is Non-repeatable, and
-the measuring instrument is normally intended for use in the absence of one of the parties involved in the transaction.
11.2. In addition, durable proof of the measurement result and the information to identify the transaction must be available upon request at the time the measurement ends.
12. Conformity Assessment
A measuring instrument should be designed in such a way that it allows an easy assessment of compliance with the applicable requirements.
A N N E X E I I
MARQUAGE CE
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A N N E X E I I I
LIST OF BASIC STANDARDS FOR COMPETENCE FOR CONFORMITY ASSESSMENT MODULES
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From More, compliance with the standard EN ISO/IEC 17025: general requirements concerning the competence of calibration and testing laboratories gives presumption of competence for the function " Testing " For organizations that perform metrological tests in the operations for which they are notified.
A N N E X E A
CONFORMITY STATEMENT ON THE MANUFACTURING INTERNAL CONTROL
BASE
1. The declaration of conformity on the basis of the internal control of manufacture shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and ensures and declares that the instruments of Applicable requirements.
Technical Documentation
2. The manufacturer establishes the technical documentation described in section 4 of this Order. The documentation shall permit the assessment of the compliance of the device with the applicable requirements. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the
. The manufacturer shall keep this documentation available to the national authorities for a period of ten years from the manufacture of the last instrument.
Manufacturing
4. The manufacturer shall take all measures necessary to ensure the conformity of the instruments manufactured to the applicable requirements.
Declaration of Conformity Statement
5.1. The manufacturer affixing the conformity marking on each measuring instrument that meets the applicable requirements.
5.2. A declaration of conformity shall be drawn up for a model of instrument and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration accompanies each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
Agent
6. The obligations of the manufacturer referred to in points 3 and 5.2 may be fulfilled, in his name and under his responsibility, by his authorised representative.
Where the manufacturer is not established in the Community and has no representative, the obligations Points 3 and 5.2 are the responsibility of the person placing the device on the market.
A N N E X E A 1
CONFORMITY DECLARATION ON THE INTERNAL CONTROL OF THE MANUFACTURING AND TESTING PRODUCED BY A NOTIFIED ORGANIZATION
1. The declaration of conformity on the basis of the internal control of the manufacture and testing of the product by a notified body shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in the present Annex, and assures and declares that the measuring instruments concerned meet the applicable requirements.
Technical Documentation
2. The manufacturer establishes the technical documentation described in the article 4 of this Order. The documentation shall permit the assessment of the compliance of the device with the applicable requirements. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the
. The manufacturer shall keep this documentation available to the national authorities for a period of ten years from the manufacture of the last instrument.
Manufacturing
4. The manufacturer shall take all measures necessary to ensure the conformity of the instruments manufactured to the applicable requirements.
Product Controls
5. A notified body chosen by the manufacturer shall carry out or have carried out checks on the product at appropriate intervals, in order to verify the quality of the internal controls of the product, taking into account, in particular, the complexity Instrumentation and production volume technology. An appropriate sample of finished products, taken by the notified body prior to the placing on the market, shall be examined and the appropriate tests, as described in the relevant documents referred to in Article 3 of the aforementioned decree of 12 April 2006, or of the Equivalent tests shall be carried out to verify the conformity of the instruments with the applicable requirements. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out.
In the case where a specified number of instruments in the sample do not conform to an acceptable level of quality, the notified body shall Takes appropriate action. If the defect persists or the organization has to suspend the checks, it informs the Legal Metrology department.
Declaration of Conformity Statement
6.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body mentioned in point 5, the identification number of the latter on each measuring instrument that satisfies the applicable requirements.
6.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration accompanies each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
Agent
7. The obligations of the manufacturer referred to in points 3 and 6.2 may be fulfilled, in his name and under his responsibility, by his authorised representative.
Where the manufacturer is not established in the Community and has no representative, the obligations Points 3 and 6.2 are the responsibility of the person placing the device on the market.
A N N E X E B
TYPE EXAMINATION
1. The type examination is the part of the conformity assessment procedure by which a notified body reviews the technical design of an instrument, and ensures and declares that the technical design satisfies the requirements applicable to The measuring instrument in question.
2. The type test can be performed using one of the following methods. The notified body shall decide on the appropriate method and samples required:
a) Examination of a sample, representative of the intended manufacture, of the complete measuring instrument.
b) Examination of samples, representative of the Envisaged manufacturing, of one or more critical parts of the measuring instrument, plus an assessment of the adequacy of the technical design of the other parts of the measuring instrument by a review of the technical documentation and evidence Referred to in point 3.
(c) Assessment of the adequacy of the technical design of the measuring instrument by examining the technical documentation and evidence referred to in point 3, without examining a sample.
3. The application for a type examination shall be submitted by the manufacturer to a notified body of his choice. It includes:
-the name and address of the manufacturer, as well as the name and address of the representative if the application is filed by the manufacturer;
-a written declaration that the same application has not been filed with another Notified body;
-the technical documentation described in Article 4 of this Order; the documentation shall permit the assessment of the conformity of the instrument with the applicable requirements; it must cover, to the extent necessary to that Evaluation, design, manufacture and operation of the device;
-the samples, representative of the intended manufacture, required by the notified body;
-evidence to establish the suitability of the design Parts of the measuring instrument for which a sample is not required. This evidence shall mention all relevant documents which have been applied, in particular where the relevant documents referred to in Article 3 of the aforementioned decree of 12 April 2006 have not been fully applied, and shall include, if necessary, Results of tests performed by the appropriate laboratory of the manufacturer or by another test laboratory, on its behalf and under its responsibility.
4. The conformity assessment of the instrument is as follows:
For samples, the notified body:
4.1. Examines the technical documentation, verifies that the samples have been manufactured in conformity with the technical documentation and identifies the elements which have been designed in accordance with the relevant provisions of the relevant documents referred to in Article 3 of the Decree Of April 12, 2006, as well as those elements whose design is not based on the provisions of the said documents;
4.2. Agree with the requester of the location where the tests and tests will be performed;
4.3. Conducts or conducts appropriate tests and tests to ensure that, in the event that the manufacturer has chosen to apply the solutions indicated in the relevant documents referred to in section 4.1 above, they have been applied Correct;
4.4. Conducts or causes the appropriate tests and tests to verify whether, in the event that the manufacturer has chosen not to apply the solutions indicated in the relevant documents referred to in Article 3 of the aforementioned decree of 12 April 2006, The solutions that it has adopted meet the applicable essential requirements.
For the other parts of the measuring instrument, the notified body:
4.5. Reviews the technical documentation and evidence to determine the adequacy of the technical design of the other parts of the measuring instrument.
For the manufacturing process, the notified body:
4.6. Reviews the technical documentation to determine if the manufacturer has the appropriate means to ensure regular manufacturing.
5. The conclusion of the statement is as follows:
5.1. The notified body shall draw up an evaluation report listing the activities carried out in accordance with paragraph 4 above and their results. Without prejudice to paragraph 37.8 of the decree of 31 December 2001, the notified body shall disclose the contents of this report, in whole or in part, only with the agreement of the
. Where the technical design satisfies the requirements applicable to the measuring instrument, the notified body shall issue to the manufacturer an EC type examination certificate. The certificate shall contain the name and address of the manufacturer, as well as his authorised representative, if applicable, the conclusions of the examination, the possible conditions of its validity and the data necessary for the identification of the device. One or more schedules can be attached to the certificate.
The certificate and its annexes contain all the relevant information for conformity assessment and in-service control. In order, in particular, to allow conformity assessment of the instruments manufactured to the type examined with regard to the reproducibility of their metrological performance when properly adjusted using the appropriate means, they Must include:
-the metrological characteristics of the device type;
-measures that ensure the integrity of the device (sealing, software identification, etc.) ;
-information about other items needed to identify the device and verify its external visual compliance to the type;
-if any, any specific information needed to verify the Characteristics of the instruments manufactured;
-in the case of a subset, all the information necessary to ensure compatibility with other subsets or measurement instruments.
The certificate has a validity of ten Years from the date of issue and may be renewed for new ten-year periods.
5.3. The notified body shall keep the evaluation report available to the Legal Metrology Service.
6. The manufacturer shall inform the notified body which holds the technical documentation relating to the EC type examination certificate of all the modifications made to the instrument, which may call into question the conformity of the instrument with the requirements Condition or conditions of validity of the certificate. These changes require a new approval in the form of an addendum to the initial CE-type examination certificate.
7. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 11 and 13 of this Order.
It shall keep the technical file, including the documentation provided by the manufacturer, for At least until the certificate is valid.
8. The manufacturer shall maintain with the technical documentation a copy of the EC type examination certificates, their annexes, additives and modifications for a period of ten years from the manufacture of the last measuring instrument, and shall keep it at Provision of national authorities.
9. The manufacturer's representative may introduce the application referred to in paragraph 3 above and pay, in the name and under the responsibility of the manufacturer, the obligations mentioned in paragraphs 6 and 8 above.
Where the manufacturer is not Established in the Community and has no representative, the obligation to communicate technical documentation on request is the responsibility of a person designated by the manufacturer.
A N N E X E C
DECLARATION OF COMPLIANCE WITH THE TYPE OF THE MANUFACTURE INTERNAL CONTROL
BASE
1. The declaration of conformity to the type on the basis of the internal control of manufacture is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and ensures and declares That the measuring instruments concerned conform to the type described in the EC type examination certificate and meet the applicable requirements.
Manufacturing
2. The manufacturer takes all of the Measures necessary to ensure conformity of the instruments manufactured to the type described in the EC type examination certificate and the applicable requirements.
Written Declaration of Conformity
3.1. The manufacturer shall affix the conformity marking on each measuring instrument which complies with the type described in the EC type examination certificate and satisfies the applicable
. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years after the manufacture of the last instrument. It shall identify the model of the instrument for which it is established.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
Agent
4. The manufacturer's obligations referred to in point 3.2 may be fulfilled, in his name and under his responsibility, by his authorised representative in the Community.
Where the manufacturer is not established in the Community and has no representative, The obligation referred to in point 3.2 is the responsibility of the person placing the device on the market.
A N N E X E C 1
CONFORMITY DECLARATION ON THE BASIS OF MANUFACTURING AND MANUFACTURING INTERNAL CONTROL THE TEST OF THE PRODUCT BY A NOTIFIED AGENCY
1. The declaration of conformity to the type on the basis of the control of the manufacture and testing of the product by a notified body is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations defined in This Annex, and assures and declares that the measuring instruments concerned conform to the type described in the EC type examination certificate and comply with the applicable requirements.
Manufacturing
2. The manufacturer shall take all necessary measures to ensure the conformity of the instruments manufactured to the type described in the EC type examination certificate and the applicable requirements.
Product Controls
3. A notified body, chosen by the manufacturer, shall carry out or have carried out checks on the product at appropriate intervals, in order to verify the quality of the internal controls of the product, taking into account, in particular, the complexity Instrumentation and production volume technology. An appropriate sample of the finished products, taken by the notified body prior to placing on the market, shall be examined and appropriate tests, as described by the relevant document (s) referred to in Article 3 of the decree of 12 April 2006, referred to above, Or equivalent tests shall be performed to verify the conformity of the product to the type described in the EC type examination certificate and the applicable requirements. In the absence of a relevant document, the notified body concerned shall decide on appropriate tests to be carried out.
In the case where a relevant number of instruments in the sample do not conform to an acceptable level of quality, the notified body shall Takes appropriate action. If the defect persists, or if the organization is to suspend the checks, it informs the legal metrology department.
Declaration of Compliance
4.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 3 above, the identification number of the latter on each measuring instrument conforming to the type described in the examination certificate Type CE that meets the applicable requirements.
4.2. A declaration of conformity shall be drawn up for each model of instrument and shall be made available to the national authorities for a period of ten years after the manufacture of the last instrument. It identifies the instrument model for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
Agent
5. The manufacturer's obligations referred to in point 4.2 above may be fulfilled, in his name and under his responsibility, by his authorised representative in the Community.
Where the manufacturer is not established in the Community and does not have Agent, the obligations referred to in point 4.2 above are the responsibility of the person placing the device on the market.
A N N E X E D
DECLARATION OF COMPLIANCE ON THE BASIC INSURANCE BASE THE QUALITY OF THE MANUFACTURING PROCESS
1. The declaration of conformity to the type on the basis of the quality assurance of the manufacturing process shall be the part of the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and Ensures and declares that the measuring instruments concerned conform to the type described in the EC type examination certificate and meet the applicable requirements.
Manufacturing
2. The manufacturer puts In respect of the production, final inspection of the product and tests of the instrument of measurement concerned, an approved quality assurance system, as specified in point 3 below, and subject to the supervision referred to in point 4 Below.
Quality Assurance System
3.1. The manufacturer shall submit to a notified body of his choice a request for the evaluation of the quality assurance system.
The application shall include:
-all relevant information on the category of measuring instruments considered ;
-the documentation for the quality assurance system;
-the technical documentation for the approved type and a copy of the CE test certificate of type.
3.2. The quality assurance system ensures the conformity of the instruments to the type described in the EC type-examination certificate and the applicable requirements.
All elements, all requirements and provisions adopted by the manufacturer must Be the subject of systematic and orderly documentation in the form of written rules, procedures and instructions. This documentation on the quality assurance system should allow for a uniform interpretation of quality programs, plans, manuals and records.
This documentation must include in particular one Adequate description:
-quality objectives and organization, management responsibilities and authorities with respect to the quality of the product;
-manufacturing, control and insurance techniques and procedures Quality and systematic actions to be used;
-tests and tests that will be performed before, during and after manufacture, and their frequency;
-quality records, such as reports Inspection and test and calibration data, reports on the qualification of the personnel concerned, etc. ;
-ways to monitor the quality required for the product and the effective operation of the quality assurance system.
3.3. The notified body shall evaluate the quality assurance system to determine whether it meets the requirements referred to in point 3.2 above. It assumes compliance with these requirements where a quality assurance system conforms to the corresponding specifications of the national standard that transposes the relevant harmonised standard, from the date on which its references were
In addition to the experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and Instrumental technology, as well as a knowledge of the applicable requirements. The assessment procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment
. The manufacturer is committed to fulfilling the obligations of the quality assurance system as approved and ensuring that it remains adequate and effective.
3.5. The manufacturer shall inform the notified body which has approved the quality assurance system of any proposed modification of the system. The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will still meet the requirements or if a re-evaluation is necessary.
It shall notify the manufacturer of its decision. The notification contains the conclusions of the monitoring and the reasoned assessment decision.
Monitoring under the responsibility of the notified body
4.1. The purpose of the monitoring is to ensure that the manufacturer properly meets the obligations arising from the approved quality assurance system.
4.2. The manufacturer shall authorise the notified body to access, for inspection purposes, the places of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:
-the documentation relating to the system Quality assurance;
-quality minutes, such as inspection reports and test and calibration data, personnel qualification reports, etc.
4.3. The notified body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality assurance system, and must provide an audit report to the manufacturer.
4.4. In addition, the notified body may make impromptu visits to the manufacturer. On the occasion of such visits, the notified body may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality assurance system. It provides the manufacturer with a report of the visit and, if tested, a test report.
Declaration of Conformity Statement
5.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 3.1 of this Annex, the identification number of the latter on each measuring instrument conforming to the type described in the EC type examination certificate that meets the applicable requirements.
5.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
6. The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the manufacture of the last instrument:
-the documentation referred to in point 3.1 of this Annex, second indent;
-the modifications Approved in point 3.5 of this Annex;
-the decisions and reports of the notified body mentioned in points 3.5, 4.3 and 4.4 of this Annex.
7. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 12 and 13 of this Order.
Agent
8. The obligations of the manufacturer referred to in points 3.1, 3.5, 5.2 and 6 of this Annex may be fulfilled, on behalf of the manufacturer and under his or her representative's name.
A N N E X E D 1
CONFORMITY STATEMENT ON THE BASIC QUALITY ASSURANCE OF THE MANUFACTURING PROCESS
1. The declaration of conformity on the basis of the quality assurance of the manufacturing process shall be the conformity assessment procedure by which the manufacturer fulfils the obligations set out below, and ensures and declares that the instruments Applicable requirements.
Technical Documentation
2. The manufacturer establishes the technical documentation described in section 4 of this Order. The documentation shall permit the assessment of the compliance of the device with the applicable requirements. It shall cover, to the extent necessary for this evaluation, the design and operation of the
. The manufacturer shall keep this documentation available to the national authorities for a period of ten years from the manufacture of the last instrument.
Manufacturing
4. The manufacturer shall implement, for the production, the final inspection of the product and the tests of the instrument of measurement concerned, an approved quality assurance system, as specified in point 5 of this Annex, and shall be submitted to the Monitoring referred to in point 6 of this annex.
Quality Assurance System
5.1. The manufacturer shall submit to a notified body of his choice a request for the evaluation of the quality assurance system.
The application shall include:
-all relevant information on the category of measuring instruments considered ;
-the quality assurance system documentation;
-the technical documentation referred to in point 2 of this appendix.
5.2. The quality assurance system shall ensure that the instruments comply with the applicable requirements. All elements, requirements and provisions adopted by the manufacturer must be systematically and systematically documented in the form of written rules, procedures and instructions. This documentation on the quality assurance system should allow for a uniform interpretation of quality programs, plans, manuals and records.
This documentation must include in particular one Adequate description:
-quality objectives and organization, management responsibilities and authorities with respect to the quality of the product;
-manufacturing, control and insurance techniques and procedures Quality and systematic actions to be used;
-tests and tests to be carried out before, during and after manufacture, and frequency;
-quality minutes, such as reports Inspection and test and calibration data, reports on the qualification of the personnel concerned, etc. ;
-ways to monitor the quality required for the product and the effective operation of the quality assurance system.
5.3. The notified body shall evaluate the quality assurance system to determine whether it meets the requirements referred to in point 5.2 of this Annex. It assumes compliance with these requirements where a quality assurance system conforms to the corresponding specifications of the national standard that transposes the relevant harmonised standard, from the date on which its references were
In addition to the experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and Instrumental technology, as well as a knowledge of the applicable requirements. The assessment procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment
. The manufacturer is committed to fulfilling the obligations of the quality assurance system as approved and to ensuring that it remains adequate and
. The manufacturer shall periodically inform the notified body which has approved the quality assurance system of any proposed modification of the system.
The notified body shall evaluate the proposed changes and decide whether the system of insurance of The modified quality will still meet the requirements or if reassessment is required.
It notifies the manufacturer of its decision. The notification contains the check conclusions and the reasoned assessment decision.
Monitoring under the responsibility of the notified body
6.1. The purpose of the monitoring is to ensure that the manufacturer properly meets the obligations arising from the approved quality assurance system.
6.2. The manufacturer shall authorise the notified body to access, for inspection purposes, the places of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:
-the documentation relating to the Quality assurance system;
-the technical documentation referred to in point 2 of this Annex;
-quality records, such as inspection reports and test and calibration data, Reports on qualification of personnel involved, etc.
6.3. The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality assurance system, and must provide an audit report to the
. In addition, the notified body may make impromptu visits to the manufacturer. On the occasion of such visits, the notified body may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality assurance system. It provides the manufacturer with a report of the visit and, if tested, a test report.
Written Statement of Compliance
7.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 5.1 of this Annex, the identification number of the latter on each instrument of measurement that meets the requirements Applicable.
7.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
8. The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the manufacture of the last instrument:
-the documentation referred to in point 5.1 of this Annex, second indent;
-the modifications Approved in point 5.5 of this Annex;
-the decisions and reports of the notified body mentioned in 5.5, 6.3 and 6.4 of this Annex.
9. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 12 and 13 of this Order.
Agent
10. The obligations of the manufacturer referred to in points 3, 5.1, 5.5, 7.2 and 8 of this Annex may be fulfilled, in his name and under his responsibility, by his representative.
A N N E X E E
CONFORMITY STATEMENT ON THE BASIC ON THE QUALITY ASSURANCE OF THE FINISHED PRODUCT INSPECTION AND TESTING
1. The declaration of conformity to the type on the basis of the quality assurance of the inspection and testing of the finished product is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations set out below, And assures and declares that the measuring instruments concerned conform to the type described in the EC type examination certificate and meet the applicable requirements.
Manufacturing
2. The manufacturer Shall implement, for the final inspection of the product and the tests of the measuring instrument concerned, an approved quality assurance system, as specified in point 3 of this Annex, and shall be subject to the supervision referred to in point 4 of the This appendix.
Quality Assurance System
3.1. The manufacturer shall submit to a notified body of his choice a request for the evaluation of the quality assurance system.
The application shall include:
-all relevant information on the category of measuring instruments considered ;
-the documentation for the quality assurance system;
-the technical documentation for the approved type and a copy of the CE test certificate of type.
3.2. The quality assurance system shall ensure the conformity of the instruments to the type described in the EC type examination certificate and the applicable requirements.
All elements, all requirements and provisions adopted by the manufacturer Shall be the subject of systematic and orderly documentation in the form of written rules, procedures and instructions. This documentation on the quality assurance system should allow for a uniform interpretation of quality programs, plans, manuals and records.
This documentation must include in particular one Adequate description:
-quality objectives and organization, responsibilities and powers of management with respect to product quality;
-tests and tests that will be performed after manufacture;
- Quality records, such as inspection reports and test and calibration data, reports on qualification of personnel involved, etc. ;
-ways to monitor the effective operation of the quality assurance system.
3.3. The notified body shall evaluate the quality assurance system to determine whether it meets the requirements referred to in point 3.2 of this Annex. It assumes compliance with these requirements where a quality assurance system conforms to the corresponding specifications of the national standard that transposes the relevant harmonised standard, from the date on which its references were
In addition to the experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and Instrumental technology, as well as a knowledge of the applicable requirements. The assessment procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment
. The manufacturer is committed to fulfilling the obligations of the quality assurance system as approved and ensuring that it remains adequate and effective.
3.5. The manufacturer shall inform the notified body which has approved the quality assurance system of any proposed modification of the system. The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will still meet the requirements or if a re-evaluation is necessary.
It shall notify the manufacturer of its decision. The notification contains the conclusions of the monitoring and the reasoned assessment decision.
Monitoring under the responsibility of the notified body
4.1. The purpose of the monitoring is to ensure that the manufacturer properly meets the obligations arising from the approved quality assurance system.
4.2. The manufacturer shall authorise the notified body to access, for inspection purposes, the inspection, testing and storage premises and shall provide it with all necessary information, in particular:
-the documentation relating to the insurance system of Quality;
-quality records such as inspection reports and test and calibration data, personnel qualification reports, etc.
4.3. The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality assurance system, and must provide an audit report to the
. In addition, the notified body may make impromptu visits to the manufacturer. On the occasion of such visits, the notified body may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality assurance system. It provides the manufacturer with a report of the visit and, if tested, a test report.
Declaration of Conformity Statement
5.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 3.1 of this Annex, the identification number of the latter on each measuring instrument conforming to the type described in the CE certificate of type that meets the applicable requirements.
5.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the instrument model for which it is based. A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
6. The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the manufacture of the last instrument:
-the documentation referred to in point 3.1 of this Annex, second indent;
-the modifications Approved in the second subparagraph of point 3.5 of this Annex;
-the decisions and reports of the notified body referred to in point 3.5 of this Annex, the last paragraph, and points 4.3 and 4.4 of this Annex.
7. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 12 and 13 of this Order.
Agent
8. The obligations of the manufacturer referred to in points 3.1, 3.5, 5.2 and 6 of this Annex may be fulfilled, in his name and under his responsibility, by his representative.
A N N E X E E 1
CONFORMITY STATEMENT ON THE QUALITY ASSURANCE BASIS OF THE FINISHED PRODUCT INSPECTION AND TESTING
1. The declaration of conformity on the basis of the quality assurance of the inspection and testing of the finished product shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and Ensures and declares that the measuring instruments concerned meet the applicable requirements.
Technical Documentation
2. The manufacturer establishes the technical documentation described in Article 4 of the This Order. The documentation shall permit the assessment of the compliance of the device with the applicable requirements. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the
. The manufacturer shall keep this documentation available to the national authorities for a period of ten years from the manufacture of the last instrument.
Manufacturing
4. The manufacturer shall implement, for the final inspection of the product and the tests of the instrument of measurement concerned, an approved quality assurance system, as specified in point 5 of this Annex, and shall be subject to the supervision mentioned In point 6 of this annex.
Quality Assurance System
5.1. The manufacturer shall submit to a notified body of his choice a request for the evaluation of the quality assurance system.
The application shall include:
-all relevant information on the category of measuring instruments considered ;
-the quality assurance system documentation;
-the technical documentation referred to in point 2 of this appendix.
5.2. The quality assurance system shall ensure that the instruments comply with the applicable requirements. All elements, requirements and provisions adopted by the manufacturer must be systematically and systematically documented in the form of written rules, procedures and instructions. This documentation on the quality assurance system should allow for a uniform interpretation of quality programs, plans, manuals and records.
This documentation must include in particular one Adequate description:
-quality objectives and organization, responsibilities and powers of management with respect to product quality;
-tests and tests that will be performed after manufacture;
- Quality records, such as inspection reports and test and calibration data, reports on qualification of personnel involved, etc. ;
-ways to monitor the effective operation of the quality assurance system.
5.3. The notified body shall evaluate the quality assurance system to determine whether it meets the requirements referred to in point 5.2 of this Annex. It assumes compliance with these requirements where a quality assurance system conforms to the corresponding specifications of the national standard that transposes the relevant harmonised standard, from the date on which its references were
In addition to the experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and Instrumental technology, as well as a knowledge of the applicable requirements. The assessment procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment
. The manufacturer is committed to fulfilling the obligations of the quality assurance system as approved and to ensuring that it remains adequate and
. The manufacturer shall inform the notified body which has approved the quality assurance system of any draft amendments to it. The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will still meet the requirements or if a re-evaluation is necessary.
It shall notify the manufacturer of its decision. The notification contains the check conclusions and the reasoned assessment decision.
Monitoring under the responsibility of the notified body
6.1. The purpose of the monitoring is to ensure that the manufacturer properly meets the obligations arising from the approved quality assurance system.
6.2. The manufacturer shall authorise the notified body to access, for inspection purposes, the inspection, testing and storage premises; it shall provide it with all necessary information, in particular:
-the documentation relating to the insurance system of Quality;
-the technical documentation referred to in point 2 of this annex;
-quality records, such as inspection reports and test and calibration data, qualification reports Personnel involved, etc.
6.3. The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality assurance system, and must provide an audit report to the
. In addition, the notified body may make impromptu visits to the manufacturer. On the occasion of such visits, the notified body may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality assurance system. It provides the manufacturer with a report of the visit and, if tested, a test report.
Written Statement of Compliance
7.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 5.1 of this Annex, the identification number of the latter on each instrument of measurement that meets the requirements Applicable.
7.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
8. The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the manufacture of the last instrument:
-the documentation referred to in point 5.1 of this Annex, second indent;
-the modifications Approved in point 5.5 of this Annex;
-the decisions and reports of the notified body mentioned in 5.5, 6.3 and 6.4 of this Annex.
9. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 12 and 13 of this Order.
Agent
10. The obligations of the manufacturer referred to in points 3, 5.1, 5.5, 7.2 and 8 of this Annex may be fulfilled, in his name and under his/her responsibility, by his representative.
A N N E X E F
DECLARATION OF COMPLIANCE WITH PRODUCT VERIFICATION
BASE TYPE
1. The declaration of conformity to the type on the basis of the verification of the product shall be the part of the conformity assessment procedure by which the manufacturer fulfils the obligations set out below, and ensures and declares that the instruments of Measure which has been submitted to the provisions of point 3 of this Annex are in conformity with the type described in the EC type examination certificate and satisfy the applicable requirements.
Manufacturing
2. The manufacturer shall take all necessary measures to ensure that the manufactured instruments conform to the approved type described in the EC type-examination certificate and the applicable requirements.
Verification
3. A notified body chosen by the manufacturer shall carry out or have carried out the appropriate tests and tests to verify the conformity of the instruments to the type described in the EC type examination certificate and the applicable requirements. Tests and tests intended to verify compliance with the metrological requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of each instrument as described in point 4 of this Annex, or by examination and testing of the Instruments on a statistical basis as described in point 5 of this
. Verification of compliance with metrological requirements by examination and testing of each instrument:
4.1. All instruments shall be examined individually and shall be subject to the appropriate tests defined in the relevant documents referred to in Article 3 of the abovementioned Decree of 12 April 2006, or to equivalent tests, in order to verify the Compliance with the metrological requirements applicable to them. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried
. The notified body shall issue a certificate of conformity limited to the examinations and tests carried out, and shall affix, or cause to be affixed, its identification number on each approved instrument.
The manufacturer shall keep the certificates of Compliance with the provision of national authorities for inspection purposes for a period of ten years after the certification of the device.
5. Statistical audit of metrological compliance:
5.1. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of each batch produced and presents its instruments to be tested as homogeneous lots.
5.2. A sample shall be drawn at random from each lot in accordance with the requirements of point 5.3 of this Annex. All instruments of the sample shall be examined individually and appropriate tests, as defined in the relevant documents referred to in Article 3 of the abovementioned Decree of 12 April 2006, or equivalent tests, in order to determine their Compliance with metrological requirements, are performed to determine the acceptance or rejection of the lot. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be performed.
5.3. The statistical procedure must meet the following requirements:
Statistical control is performed by attributes. The sampling system must ensure:
-a quality level corresponding to an acceptance probability of 95 % of a lot with a non-compliance rate of less than 1 %;
-a limit quality that corresponds to a probability 5 % acceptance of a lot with a non-compliance rate of less than 7 %.
5.4. When a lot is accepted, all the instruments in that lot are accepted, with the exception of the instruments of the sample that have not satisfied the tests.
The notified body shall issue a certificate of conformity limited to the tests and tests
manufacturer shall keep the certificates of conformity at the disposal of the national authorities for the purpose of inspection during an inspection. Period ending 10 years after the device is certified.
5.5. If a lot is rejected, the notified body shall take the appropriate measures to prevent the lot from being placed on the market. In the event of frequent rejection of consignments, the notified body may suspend the statistical verification and take appropriate measures. If the defect persists or the organization has to suspend the checks, it informs the Legal Metrology department.
Declaration of Conformity Statement
6.1. The manufacturer shall affix the conformity marking on each measuring instrument conforming to the approved type that meets the applicable
. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years after the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
7. If the notified body mentioned in point 3 of this Annex agrees, the manufacturer shall also, under the responsibility of that body, affix the identification number of the notified body to the measuring
. Agreement, the manufacturer may, under the responsibility of the manufacturer, affix the manufacturer's identification number to the measuring instruments during the manufacturing process.
Agent
8. The obligations of the manufacturer may be fulfilled, on its behalf and under its responsibility, by its representative, with the exception of the obligations set out in points 2 and 5.1 of this annex.
A N N E X E F 1
DECLARATION COMPLIANCE ON THE
PRODUCT AUDIT BASE
1. The declaration of conformity on the basis of the verification of the product shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and ensures and declares that the measuring instruments Which have been submitted to the provisions of point 5 of this Annex are in accordance with the applicable requirements.
Technical Documentation
2. The manufacturer shall prepare the technical documentation described in Article 4 of this Order. The documentation shall permit the assessment of the compliance of the device with the applicable requirements. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the
. The manufacturer shall keep this documentation available to the national authorities for a period of ten years from the manufacture of the last instrument.
Manufacturing
4. The manufacturer shall take all necessary measures to ensure that the manufactured instruments comply with the applicable requirements.
Verification
5. A notified body chosen by the manufacturer shall carry out or have carried out the appropriate tests and tests to verify the conformity of the instruments with the applicable requirements. Tests and tests intended to verify the conformity with the metrological requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of each instrument as described in point 6 of this Annex, or by inspection and testing of the Instruments on a statistical basis as described in point 7 of this
. Verification of compliance with metrological requirements by monitoring and testing of each instrument:
6.1. All instruments shall be examined individually and shall be subject to the appropriate tests defined in the relevant documents referred to in Article 3 of the abovementioned Decree of 12 April 2006, or to equivalent tests, in order to verify the Compliance with the metrological requirements applicable to them. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried
. The notified body shall issue a certificate of conformity limited to the examinations and tests carried out, and shall affix, or cause to be affixed, its identification number on each approved instrument.
The manufacturer shall keep the certificates of Compliance with the provision of national authorities for inspection purposes for a period of ten years after the certification of the device.
7. Statistical audit of metrological compliance:
7.1. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of each batch produced and presents its instruments to be verified as homogeneous lots.
7.2. A sample shall be drawn at random from each lot in accordance with the requirements of point 7.3 of this Annex. All instruments of the sample shall be examined individually and the appropriate tests, as defined in the relevant documents referred to in Article 3 of the abovementioned Decree of 12 April 2006, or equivalent tests, in order to determine their Compliance with metrological requirements, are performed to determine the acceptance or rejection of the lot. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried
. The statistical procedure must meet the following requirements.
Statistical control is performed by attributes. The sampling system must ensure:
-a quality level corresponding to a 95 % probability of acceptance for a lot with a non-compliance rate of less than 1 %;
-a limit quality that corresponds to a probability 5 % acceptance for a lot with a non-compliance rate of less than 7 %.
7.4. When a lot is accepted, all instruments of that lot shall be accepted, with the exception of the instruments of the sample which have proved to be non-compliant.
The notified body shall issue a certificate of conformity limited to the tests and tests
manufacturer shall keep the certificates of conformity at the disposal of the national authorities for the purpose of inspection during an inspection. Period ending 10 years after certification of the device.
7.5. If a lot is rejected, the notified body shall take the appropriate measures to prevent the lot from being placed on the market. In the event of frequent rejection of consignments, the notified body may suspend the statistical verification and take appropriate measures. If the defect persists, or if the organization is to suspend the checks, it informs the legal metrology department.
Declaration of Compliance
8.1. The manufacturer affixing the conformity marking on each measuring instrument that meets the applicable requirements.
8.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years after the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
9. If the notified body mentioned in point 5 of this Annex agrees, the manufacturer shall also, under the responsibility of that body, affix the manufacturer's identification number to the measuring instruments.
If the notified body Agreement, the manufacturer may, under the responsibility of the manufacturer, affix the manufacturer's identification number to the measuring instruments during the manufacturing process.
Agent
10. The obligations of the manufacturer may be fulfilled, on its behalf and under its responsibility, by its agent, with the exception of the obligations set out in points 4 and 7.1 of this annex.
A N N E X E G
DECLARATION COMPLIANCE ON THE
AUDIT BASE IN UNIT
1. The declaration of conformity on the basis of verification to the unit shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and assures and declares that a measuring instrument which has Submitted to the provisions of point 4 of this Annex shall comply with the applicable requirements.
Technical Documentation
2. The manufacturer shall draw up the technical documentation described in Article 4 of the Shall make it available to the notified body referred to in point 4 of this Annex. The technical documentation shall permit the assessment of the conformity of the device with the applicable requirements and shall, to the extent necessary for this evaluation, cover the design, manufacture and operation of the instrument
Manufacturer keeps this documentation available to the national authorities for a period of ten years.
Manufacturing
3. The manufacturer shall take all necessary measures to ensure that the device manufactured meets the applicable requirements.
Verification
4. A notified body chosen by the manufacturer shall carry out or have carried out the appropriate tests and tests described in the relevant documents referred to in Article 3 of the abovementioned Decree of 12 April 2006, or equivalent tests to verify the Compliance of the device with applicable requirements. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out.
The notified body shall issue a certificate of conformity limited to the examinations and tests carried out and affix or cause to be affixed, under its Responsibility, its identification number on the approved device.
The manufacturer keeps the certificates of compliance available to the national authorities for inspection for a period of ten years after certification Of the device.
Declaration of Compliance
5.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 4 of this Annex, the identification number of the latter on the measuring instrument if it meets the requirements Applicable.
5.2. A declaration of conformity shall be drawn up and shall be held at the disposal of the national authorities for a period of ten years from the certification of the instrument. It identifies the device for which it is based.
A copy of the declaration must be provided with each measurement instrument placed on the market.
Agent
6. The obligations of the manufacturer referred to in points 2 and 5.2 of this Annex may be fulfilled, in his name and under his/her responsibility, by his representative.
A N N E X E H
COMPLIANCE STATEMENT ON THE BASE
DE FULL QUALITY ASSURANCE
1. The declaration of conformity on the basis of the full quality assurance shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and ensures and declares that the instruments of Measure meets the applicable requirements.
Manufacturing
2. The manufacturer implements, for the design, manufacturing, final product inspection and testing of the Measure concerned, an approved quality assurance system, as specified in point 3 of this Annex, and shall be subject to the supervision referred to in point 4 of this Annex.
Quality Assurance System
3.1. The manufacturer shall submit to a notified body of his choice a request for the evaluation of the quality assurance system.
The application shall include:
-all relevant information on the category of measuring instruments considered ;
-the quality assurance system documentation.
3.2. The quality assurance system ensures compliance of the instruments with the applicable requirements.
All elements, requirements and provisions adopted by the manufacturer must be systematically documented and In the form of written rules, procedures and instructions. This quality assurance system documentation should allow for a consistent interpretation of quality programs, plans, manuals and minutes. This documentation should include, in particular, an adequate description of:
-quality objectives and organization, management's responsibilities and authorities with respect to the quality of the design and product;
- Specifications of the technical design, including standards, which will be applied and, where the relevant documents referred to in Article 3 of the aforementioned decree of 12 April 2006 are not fully applied, means which will be used for Ensure that the essential requirements for instruments are met;
-systematic design control and verification techniques, procedures and actions that will be used during the design of instruments The category in question;
-manufacturing, quality control and assurance techniques and procedures and systematic actions to be used;
-tests and tests that will be carried out before, during and after the Manufacturing, and their frequency;
-quality records, such as inspection reports and test and calibration data, personnel qualification reports, etc. ;
-ways to monitor the achievement of the quality required for the design and the product and the efficient operation of the quality assurance system.
3.3. The notified body shall evaluate the quality assurance system to determine whether it meets the requirements referred to in point 3.2 of this Annex. It assumes compliance with these requirements where a quality assurance system conforms to the corresponding specifications of the national standard that transposes the relevant harmonised standard, from the date on which its references were
In addition to the experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and Instrumental technology, as well as a knowledge of the applicable requirements. The assessment procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment
. The manufacturer is committed to fulfilling the obligations of the quality assurance system as approved and ensuring that it remains adequate and effective.
3.5. The manufacturer shall inform the notified body which has approved the quality assurance system of any proposed modification of the system.
The notified body shall evaluate the proposed changes and decide whether the quality assurance system Amended to meet the requirements set out in section 3.2 of this schedule or if a re-evaluation is required.
It shall notify the manufacturer of its decision. The notification contains the conclusions of the monitoring and the reasoned assessment decision.
Monitoring under the responsibility of the notified body
4.1. The purpose of the monitoring is to ensure that the manufacturer properly meets the obligations arising from the approved quality assurance system.
4.2. The manufacturer shall authorise the notified body to access, for inspection purposes, the places of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:
-the documentation relating to the Quality assurance system;
-minutes of quality, as provided for by the party " Design " The quality assurance system, such as the results of analyses, calculations, tests, etc. ;
-quality records, as expected by the party " Manufacturing " The quality assurance system, such as inspection reports and test and calibration data, personnel qualification reports, etc.
4.3. The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality assurance system, and must provide an audit report to the
. In addition, the notified body may make impromptu visits to the manufacturer. On the occasion of such visits, the notified body may, if necessary, carry out or cause to be carried out, under its responsibility, product tests intended to verify the proper functioning of the quality assurance system. It provides the manufacturer with a report of the visit and, if tested, a test report.
Declaration of Conformity Statement
5.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 3.1 of this Annex, the identification number of the latter on each instrument of measurement that meets the requirements Applicable.
5.2. A declaration of conformity shall be drawn up for a model of instrument and shall be made available to the national authorities for a period of ten years after the manufacture of the last instrument. It identifies the model of the instrument for which it is based.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
6. The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the date of manufacture of the last instrument:
-the documentation concerning the quality assurance system referred to in point 3.1 of the Annex, second indent;
-the approved amendments referred to in paragraph 3.5 of this Annex;
-the decisions and reports of the notified body mentioned in points 3.5, 4.3 and 4.4 of this Annex.
7. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 12 and 13 of this Order.
Agent
8. The obligations of the manufacturer referred to in points 3.1, 3.5, 5.2 and 6 of this Annex may be fulfilled, in his name and under his responsibility, by his authorised representative.
A N N E X E H 1
COMPLIANCE STATEMENT ON THE QUALITY ASSURANCE AND CONCEPTION CONTROL UNIT
1. The declaration of conformity on the basis of full quality assurance and design control shall be the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this Annex, and ensures and Declares that the measuring instruments considered meet the applicable requirements.
Manufacturing
2. The manufacturer implements, for the design, manufacturing, final product inspection and The tests of the instrument of measurement concerned, an approved quality assurance system, as specified in point 3 of this Annex, and shall be subject to the supervision referred to in point 5 of this Annex. The adequacy of the design of the measuring instrument must have been controlled in accordance with the provisions of point 4 of this annex.
Quality Assurance System
3.1. The manufacturer shall submit to a notified body of his choice a request for the evaluation of the quality assurance system.
The application shall include:
-all relevant information on the category of measuring instruments considered ;
-the quality assurance system documentation.
3.2. The quality assurance system ensures compliance of the instruments with the applicable requirements.
All elements, requirements and provisions adopted by the manufacturer must be systematically documented and In the form of written rules, procedures and instructions. This quality assurance system documentation should allow for a consistent interpretation of quality programs, plans, manuals and records. This documentation should include, in particular, an adequate description of:
-quality objectives and organization, management responsibilities and authorities with respect to the quality of the design and product;
- Technical design specifications, including standards, which will be applied and, where the relevant documents referred to in Article 3 of the aforementioned decree of 12 April 2006 are not fully applied, the means to be used To ensure that the essential requirements for instruments are met;
-systematic design control and verification techniques, procedures and actions that will be used during the design of the Instruments of the category in question;
-manufacturing, quality control and assurance techniques and procedures and systematic actions to be used;
-tests and tests that will be carried out before, during and After manufacture, and frequency;
-quality records, such as inspection reports and test and calibration data, personnel qualification reports, etc. ;
-ways to monitor the achievement of the quality required for the design and the product and the efficient operation of the quality assurance system.
3.3. The notified body shall evaluate the quality assurance system to determine whether it meets the requirements referred to in point 3.2 of this Annex. It assumes compliance with these requirements where a quality assurance system conforms to the corresponding specifications of the national standard that transposes the relevant harmonised standard, from the date on which its references were
In addition to the experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and Instrumental technology, as well as a knowledge of the applicable requirements. The assessment procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment
. The manufacturer is committed to fulfilling the obligations of the quality assurance system as approved and ensuring that it remains adequate and effective.
3.5. The manufacturer shall inform the notified body which has approved the quality assurance system of any proposed modification of the system. The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system still meets the requirements referred to in point 3.2 of this Annex or whether a re-evaluation is necessary.
It shall notify its Decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment
. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 12 and 13 of this Order.
Design Control
4.1. The manufacturer shall submit to the notified body mentioned in point 3.1 of this Annex a request for examination of the design.
4.2. The application shall provide an understanding of the design, manufacture and operation of the device and shall be capable of assessing its compliance with the applicable requirements. It includes:
-the name and address of the manufacturer;
-a written declaration that the same request has not been made to another notified body;
-the technical documentation described in Article 4 of the present The documentation shall permit the assessment of the conformity of the instrument with the applicable requirements; it must cover, to the extent necessary for this evaluation, the design and operation of the instrument;
-the evidence to be Support for the adequacy of the technical design. This evidence shall mention all the documents which have been applied, in particular where the relevant documents referred to in Article 3 of the aforementioned decree of 12 April 2006 have not been fully applied, and shall include, if necessary, the Results of tests performed by the appropriate laboratory of the manufacturer or by another test laboratory on its behalf and under its responsibility.
4.3. The notified body shall examine the application and, where the design complies with the provisions applicable to the measuring instrument, it shall issue to the manufacturer a certificate of CE examination of the design. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the possible conditions of its validity and the data necessary for the identification of the approved
. All relevant parts of the technical documentation are attached to the certificate.
4.3.2. The certificate or its annexes shall contain all relevant information concerning conformity assessment and in-service control. In particular, in order to permit the conformity assessment of the instruments manufactured at the examined design with regard to the reproducibility of their metrological performance when properly adjusted using the means provided, these Information includes:
-the metrological characteristics of the instrument design;
-measures to ensure the integrity of the device (sealing, software identification, etc.) ;
-information about other items needed to identify the device and verify its external visual compliance to the design;
-if applicable, any specific information required for Verify the characteristics of the manufactured instruments;
-in the case of subsets, all the information necessary to ensure compatibility with other sub-assemblies or measuring instruments.
4.3.3. The notified body shall draw up an evaluation report in this respect and shall keep it at the disposal of the legal metrology department. Without prejudice to paragraph 37.8 of the aforementioned decree of 3 May 2001, the notified body shall disclose the contents of this report in whole or in part only with the agreement of the manufacturer.
The certificate shall be valid for ten years from the date of And may be renewed for new ten-year periods.
If an EC design examination certificate is denied to the manufacturer, the notified body provides the detailed reasons for the refusal.
4.4. The manufacturer shall inform the notified body which has issued the EC examination certificate of the design of all the fundamental modifications of the approved design. These amendments shall be subject to further approval by the notified body which has issued the EC design examination certificate where such modifications may call into question the conformity of the instrument with the Applicable essential requirements, the conditions of validity of the certificate or the conditions prescribed for the use of the instrument. The additional approval is issued as an addendum to the initial EC design examination certificate.
4.5. The notified body shall provide information to the authorities responsible for metrological control under the conditions laid down in Articles 11 and 13 of this
. The manufacturer, or his authorised representative, shall retain with the technical documentation a copy of the CE examination certificates of the design, their annexes and their additives for a period of ten years from the manufacture of the last instrument of the Measure, and shall keep it available to national authorities. Where neither the manufacturer nor his authorised representative is established in the Community, the obligation to communicate the technical documentation on request shall be the responsibility of the person designated by the manufacturer.
Monitoring under the Notified Body
5.1. The purpose of the monitoring is to ensure that the manufacturer properly meets the obligations arising from the approved quality assurance system.
5.2. The manufacturer shall authorise the notified body to access, for inspection purposes, the places of design, manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:
-the documentation Relating to the quality assurance system;
-records relating to quality as provided for by the party " Design " The quality assurance system, such as the results of analyses, calculations, tests, etc. ;
-quality records, as expected by the party " Manufacturing " The quality assurance system, such as inspection reports and test and calibration data, personnel qualification reports, etc.
5.3. The notified body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality assurance system, and must provide an audit report to the manufacturer.
5.4. In addition, the notified body may make impromptu visits to the manufacturer. On the occasion of such visits, the notified body may, if necessary, carry out or cause to be carried out, under its responsibility, product tests intended to verify the proper functioning of the quality assurance system. It provides the manufacturer with a visitation report and, if tested, a test report.
Written Statement of Compliance
6.1. The manufacturer shall affix the conformity marking and, under the responsibility of the notified body referred to in point 3.1 of this Annex, the identification number of the latter on each instrument of measurement that meets the requirements Applicable.
6.2. A declaration of conformity shall be drawn up for each instrument model and shall be made available to the national authorities for a period of ten years from the manufacture of the last instrument. It identifies the model of the device for which it is based and the CA certificate number of the design.
A copy of the declaration must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual instruments, when many instruments are delivered to a single user.
7. The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the date of manufacture of the last instrument:
-the documentation referred to in point 3.1 of this Annex, second indent;
-the Approved amendments referred to in paragraph 3.5 of this Annex;
-the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4 of this Annex.
Agent
8. The manufacturer's obligations referred to in points 3.1, 3.5, 6.2 and 7 of this annex may be fulfilled, on behalf of the manufacturer and under his or her agent's responsibility.
A N N E X E M I-0 1
WATER PLANTS
The relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex apply to water meters intended to measure volumes Clean, cold or hot water in a residential, commercial or light industrial environment.
Definitions
Water Meter:
An instrument designed to measure, store and display in the Measuring conditions, the volume of water passing through the measuring transducer.
Minimum Flow Rate (Q1):
The lowest flow rate at which the water meter provides indications that meet the maximum tolerated error requirements (EMT).
Transition rate (Q2):
The rate between the permanent rate and the minimum rate, at which the flow rate is divided into two zones, the " Upper zone " And the " Lower zone ", each zone having a caracteristic EMT.
Permanent rate (Q3):
The highest rate at which the water meter operates satisfactorily under normal conditions of use, i.e. under conditions of Constant or intermittent flow
Overload rate (Q4):
The highest rate at which the meter is operating satisfactorily for a short period of time without deterioration.
Requirements Specific
Operating conditions
The manufacturer must specify the operating conditions of the device, including:
1. The extent of water flows that must meet the following conditions:
Q3/Q1 10.
Q2/Q1 = 1.6.
Q4/Q3 = 1.25.
Until April 29, 2009, the Q2/Q1 report can have one of the following values: 1.5, 2.5, 4, or 6.3.
2. The temperature range of the water that must meet the following conditions:
0.1 ° C to at least 30 ° C, or
30 ° C at a high temperature, this temperature being at least 90 ° C.
The meter may be designed to operate on the Range.
3. The relative water pressure range from 0.3 bar to at least 10 bar at Q3.
4. The nominal value of the ac power supply or the current power supply limits.
5. Maximum Tolerated Errors:
EMTs for volumes delivered at flows between the included transition rate (Q2) and the overloading rate (Q4) included are:
-2 %, more or less, for water with a temperature of 30 ° C,
-3 %, more or less, for water with temperature > 30 ° C.
6. TRAs for volumes dispensed at flows between the included minimum flow (Q1) and the excluded transition rate (Q2) are 5 %, in addition or less, regardless of the water temperature.
7. Tolerable effects of electromagnetic disturbances:
7.1. The effect of an electromagnetic disturbance on a water meter shall be such that:
-the variation of the measurement result is not greater than the critical variation defined in point 7.3 of this annex, or
-the indication of the Result of measurement is such that it cannot be interpreted as a valid result, such as a momentary variation that cannot be interpreted, stored or transmitted as a measurement result.
7.2. After an electromagnetic disturbance, the water meter must:
-recover to run within EMT limits;
-save all metering functions, and
-retrieve all data from the Measurement present just before the disturbance.
7.3. The critical variation is the smallest of the following two values:
-the volume corresponding to half the absolute value of the EMT in the upper zone of the range of flows;
-the volume corresponding to the absolute value of the EMT Applied to the volume corresponding to one minute at throughput Q3.
8. Sustainability:
After an appropriate test has been performed taking into account a period evaluated by the manufacturer, the following criteria must be met:
8.1. After the durability test, the variation of the measurement against the initial measurement shall not exceed:
3 % of the volume measured between included Q1 and Q2 excluded;
1.5 % of the volume measured between included Q2 and Q4 included.
8.2. The indication error for the volume measured after the durability test must not be greater than:
6 % of the volume measured between included Q1 and Q2 excluded;
2.5 % of the volume measured between included Q2 and Q4 included for water meters Measuring a water temperature between 0.1 ° C and 30 ° C;
3.5 % of the volume measured between Q2 inclusive and Q4 included for water meters intended to measure water temperature between 30 ° C and 90 ° C.
9. Dequation:
9.1. The meter shall be capable of being installed in such a way that it can operate in any position, unless it is clearly marked on the instrument that it otherwise works.
9.2. The manufacturer must specify whether the meter is designed to measure inverse flows. In the case of a meter designed to measure inverse flows, the reverse flow volume must be either subtracted from the cumulative volume, or recorded separately. The same maximum permissible error applies to the normal flow and the reverse flow.
Water meters that are not designed to measure reverse flow must either prevent the reverse flow, or resist an accidental reverse flow without suffering No deterioration or modification of metrological properties.
10. Units of Measure:
The measured volume must be displayed in cubic meters.
11. Commissioning:
The operating conditions set out in points 1, 2 and 3 of this annex shall be determined by the water distributor or the person legally designated for the installation of the meter, so that The meter is capable of accurately measuring expected or expected consumption.
Conformity Assessment
The conformity assessment procedures among which the manufacturer may Choose:
B + F or B + D or H1.
A N N E X E M I-0 2
GAS COMPTORS
AND VOLUME CONVERSION DEVICES
The relevant requirements of Annex I, the specific requirements of the Annex and the conformity assessment procedures listed in this Annex shall apply to gas meters and volume conversion devices defined below and intended for use in residential, commercial or
Definitions
Gas Meter:
A device designed to measure, store and display the amount of fuel gas (volume or mass) passing through it.
Conversion:
A device mounted on a gas meter, which automatically converts the measured quantity to a quantity under the basic conditions.
Minimum rate (Qmin):
The lowest rate at which the Gas meter provides indications that meet the maximum tolerated error (MRT) requirements.
Maximum rate (Qmax):
The highest rate at which the gas meter provides indications that meet the requirements For EMT under normal conditions of use, that is, in constant or intermittent flow conditions.
Transition Flow (Qt):
The rate between the maximum flow rate and the minimum flow rate, at which the range of flows is Divided into two zones, the " Upper zone " And the " Lower field ", each area with a typical EMT.
Overload rate (Qr):
The highest rate at which the meter operates for a short period of time without deteriorating.
Basic conditions:
Conditions Specified to which the measured gas quantity is converted.
Part I
Specific requirements for
1 gas meters. Operating Conditions
The manufacturer must specify the assigned conditions for the operation of the gas meter, taking into account the following:
1.1. The extent of gas flows must meet at least the following conditions:
You can view the table in OJ
No 120, 24/05/2006 text number 9
1.2. The temperature of the gas shall be at least 40 ° C.
1.3. The meter shall be designed for the range of gases and supply pressures of the destination country. The manufacturer must include:
-the family or gas group for which the meter is designed;
-its maximum operating pressure.
1.4. The temperature range for the climate environment must be at least 50 ° C.
1.5. The nominal value of the ac power supply or the dc power supply limits must be specified.
2. Maximum Tolerated Errors (EMT)
2.1. In the case of a gas meter indicating the volume in the measurement conditions or the mass, the TRMs, positive or negative, are given in the table below.
Table 1
You can Consult the table in OJ
No 120 of 24/05/2006 text number 9
When errors between Qt and Qmax have the same sign, they should not exceed 1 % for class 1.5 and 0.5 % for the class 1.0.
2.2. In the case of a meter which indicates only the volume converted according to the temperature, the absolute value of the EMT of the meter shall be increased by 0.5 % in a range of 30 ° C systematically extending from both sides of a temperature Specified by the manufacturer, which is between 15 ° C and 25 ° C. Outside this range, an additional increase of 0.5 % is allowed for each interval of 10 ° C.
3. Allowable Effect of Disturbances
3.1. Electromagnetic immunity:
3.1.1. The effect of an electromagnetic disturbance on a gas meter or a volume conversion device shall be such that:
-the variation of the measurement result is not greater than the critical variation defined in point 3.1.3 of the Present annex; or
-the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a momentary variation that cannot be interpreted, stored or transmitted as a result of Metering.
3.1.2. After having undergone an electromagnetic disturbance the gas meter must:
-recover to operate within the limits of EMT; and
-save all metering functions; and
-retrieve all data from the Measurement present just prior to disturbance.
3.1.3. The critical variation is the smallest of the following values:
-the absolute value of the EMT in the upper zone of the flow range;
-the absolute value of the EMT corresponding to one minute at the maximum rate.
3.2. Effect of flow disturbances:
The effect of flow disturbances upstream and downstream of the meter under the installation conditions specified by the manufacturer must not exceed one third of the EMT.
4. Sustainability
After an adequate test has been performed taking into account a period estimated by the manufacturer, the following criteria must be met:
4.1. Class 1.5 meters:
4.1.1. After the durability test, the variation of the measurement result against the initial measurement result for flow rates in Qt to Qmax should not be greater than 2 %.
4.1.2. The error of indication after the durability test shall not exceed twice the EMT provided for in point 2 of this Annex.
4.2. Class 1.0 meters:
4.2.1. After the durability test, the variation of the measurement against the initial measurement shall not exceed one third of the EMT provided for in point 2 of this annex.
4.2.2. The error of indication after the durability test shall comply with the maximum tolerated errors set out in point 2 of this annex.
5. Dequation
5.1. A gas meter supplied by the sector (alternating current or continuous current) shall be equipped with a back-up power supply or other means ensuring the safety of all the measuring functions during a failure of the Primary power source.
5.2. A stand-alone energy source must have a life span of at least five years. After 90 % of its life, an appropriate warning must be displayed.
5.3. An indicator device must have a sufficient number of digits so that the quantity spent for 8 000 hours at Qmax does not reduce the indication to its initial value.
5.4. The gas meter shall be capable of being installed in such a way that it can operate in any position declared by the manufacturer in its installation instructions.
5.5. The gas meter shall have a test element which will allow testing within a reasonable time frame.
5.6. The gas meter shall respect maximum tolerated errors regardless of the direction of the flow, or only in the direction of the flow when clearly indicated.
6. Units
The measured quantity must be displayed in cubic meters, m³ symbol, or in kilograms, symbol kg.
Part II
Specific requirements for
volume conversion devices
A volume conversion device constitutes a subset within the meaning of the second indent, definition b, of Article 1 of this Order. The relevant essential requirements applicable to gas meters are also applicable to volume conversion devices, which must also meet the following requirements:
7. Basic conditions
The manufacturer must specify the basic conditions for the converted quantities.
8. Maximum Tolerated Errors (EMT)
Considering the meter without error, EMT, positive or negative, applicable to the conversion devices are:
0.5 % of the measured value at an ambient temperature of 20 ° C 3 ° C, An ambient humidity of 60 % 15 % and for nominal values of electrical power;
0.7 % of the measured value for temperature conversion devices only under assigned operating conditions ;
1 % of the value measured for other conversion devices under assigned operating conditions.
9. Dating
9.1. An electronic conversion device shall be capable of detecting an operation outside the operating range (s) indicated by the manufacturer for the parameters which are important for the accuracy of the measurement. The conversion device must stop integrating the converted size and can aggregate the converted size separately during the time it is outside the operating range (s).
9.2. An electronic conversion device must be capable of displaying all relevant data for metering without additional equipment.
Part III
Service Implementation and Conformity Assessment
Service
a) A residential meter must either belong to class 1.5 or have a Qmax/Qmin ratio equal to or greater than 150 if it is of class 1.0.
b) A Class 1.5 meter is sufficient for the Measurement for commercial or light industrial use.
(c) The operating conditions set out in points 1.2 and 1.3 of this annex shall be determined by the gas distributor or the person legally designated for Meter installation, so that the meter is able to accurately measure expected or expected consumption.
Compliance Evaluation
The evaluation procedures for the meter Compliance with which the manufacturer may choose are:
B + F or B + D or H1.
A N N E X E M I-0 3
ELECTRIC POWER PLANTS ACTIVE
The relevant requirements of Annex I, the Specific requirements of this Annex and the conformity assessment procedures listed in this Annex shall apply to active electric energy meters intended for residential, commercial or light industrial use.
Note. -Electric energy meters can be used in combination with external measurement transformers, depending on the applied measurement technique. However, this annex relates only to electrical energy meters and not measurement transformers.
Definition
An active electric energy meter is a device that measures The active electrical energy consumed in a circuit.
Symbols
I: electrical current passing through the meter.
Ist: the lowest declared value of I to which the meter registers Active electrical energy with unit power factor (polyphase load balanced meters).
Imin: value of I beyond which the error is within the limits of maximum tolerated errors (polyphase-dependent meters Balance).
Itr: value of I beyond which the error is within the lowest EMT limits corresponding to the meter class index.
Imax: maximum value of I for which the error is within the bounds of the EMT.
In: the specified reference current for which the transformer powered by a transformer was designed.
U: voltage of the electricity supplied to the meter.
One: Reference voltage specified.
f: voltage frequency provided to the Meter.
fn: the specified reference frequency.
FP: power factor, or cosw, the cosine of the phase difference w between I and U.
Specific requirements
1. Accuracy
The manufacturer must specify the meter class index, of: class A, class B, or class C.
2. Assigned Operating Conditions
The manufacturer must specify the conditions assigned to operate the meter, including the fn, Un, In, Ist, Imin, Itr, and Imax values that apply to the meter.
For the Specified current values, the meter shall meet the conditions set out in Table 1 of this annex.
Table 1
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The ranges of voltage, frequency and power factor within which the meter must meet the maximum permissible error requirements are specified in the Table 2 of this Annex. These ranges must take into account typical features of electricity supplied by public distribution systems, such as voltage and frequency.
Voltage and frequency values are within the following limits :
0.9 x A U 1.1 x A
0.98 x fn f 1.02 x fn
The power factor is within the following limits: from cosw = 0.5 inductive to cosw = 0.8 capacitive.
3. Maximum Tolerated Errors
The effects of the different gauges and influence sizes (a, b, c ...) are evaluated separately, with all other measurement and influence sizes being maintained relatively constant to their Reference value. The measurement error, which should not be greater than the EMT specified in Table 2, is calculated as follows:
Measurement Error = Ea² + b² + c² ...
When the meter works at variable load currents, errors in percent Must not exceed the limits shown in Table 2 below.
Table 2
EMT, in percent, under assigned operating conditions,
based on load current and temperature of Operation
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However, for polyphase electromechanical meters, the current range for Single phase loads is limited to the interval defined by: 5 x Itr I Imax.
When a meter operates in multiple temperature ranges, the relevant values of maximum tolerated errors for each extent are applicable.
4. Disrupted Effect
4.1. General:
Electricity meters are directly connected to the power supply and the current sector is also one of the meters, a special electromagnetic environment is used for meters
meter shall comply with the E2 electromagnetic environment and the additional requirements set out in points 4.2 and 4.3 of this Annex. The electromagnetic environment and the tolerated effects take into account the fact that long-term disturbances do occur, which must not affect the accuracy beyond the critical variation, and transient disturbances, which may Temporarily cause a degradation or loss of function or result, but the meter must overcome, and must not affect the accuracy beyond the critical variation. Where there are foreseeable high risks associated with lightning and in the event of a predominance of air power systems, the metrological characteristics of the meter must be protected.
4.2. Effect of long-term disturbances:
Critical variations for long-term disturbances are given in Table 3 below.
Table 3
Critical changes for long-term disturbances Duration
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4.3. Sustained effect of transient electromagnetic phenomena:
4.3.1. The effect of a transient electromagnetic disturbance on an electric energy meter shall be such that, during and immediately after the disturbance, no output intended to test the meter's accuracy produces impulses or Signals corresponding to an energy greater than the critical variation.
In addition, within a reasonable period of time after the disturbance, the meter must:
-resume operation within EMT limits; and
-save all Metering functions; and
-to allow the recovery of all metering data present immediately before the perturbation; and
-do not indicate a change in the recorded energy greater than the critical variation.
The Critical variation in kWh is m x One x Imax x 10-6 (m being the number of meter measuring elements, One being expressed in volts and Imax in amperes).
4.3.2. For over-intensity, the critical variation is 1.5 %.
5. Dequation
5.1. Below the assigned operating voltage, the positive error of the meter shall not exceed 10 %.
5.2. The total energy display shall contain a sufficient number of digits for the indication to not return to its initial value when the meter operates for 4 000 h at full load (I = Imax, U = Un and FP = 1), and shall not be able to Be reset in use.
5.3. In the case of a loss of electricity in the circuit, the measured electrical energy quantities shall be capable of being read for at least 4 months.
5.4. When the tension is applied while the circuit is not crossed by current (the circuit must be open), the meter shall not record any energy regardless of the tension between 0.8 x One and 1.1 x One.
5.5. The meter shall start and continue to record at the specified reference voltage, a power factor equal to one (FP = 1; polyphase meter with balanced loads) and a current equal to Ist.
6. Units
The measured electrical energy must be specified in kilowatt hours or in megawatt hours.
7. Commissioning
a) For residential metering, at least one Class A meter is sufficient, as a general rule. However, a Class B meter is required in the following cases:
-when the Imax intensity is greater than or equal to 45 A in the case of a single phase connection or 15 A for a three-phase connection;
-when the meter Registers in different registers each other consumption corresponding to specific time periods;
-for other specific applications defined by decision of the Minister responsible for industry.
(b) For the purposes of Devices for commercial or light industrial use, a meter of class B at least is required. However, a Class C meter is required in the following cases:
-when the Imax intensity is greater than or equal to 90 A in the case of a three-phase connection;
-when the meter is connected behind a current transformer, Only;
-for other specific applications defined by decision of the Minister responsible for industry.
(c) The extent specified for the current shall be determined by the electricity distributor or the person legally designated for that purpose. Meter installation, so that the meter is able to accurately measure expected or expected consumption.
Compliance Evaluation
The evaluation procedures for the meter Compliance with which the manufacturer may choose are:
B + F or B + D or H1.
A N N E X E M I-0 4
THERMAL ENERGY ACCOUNTORS
The relevant requirements of Annex I, the requirements Specific and the conformity assessment procedures listed in this Annex shall apply to the thermal energy meters defined below for residential, commercial or light industrial use.
Definitions
A thermal energy meter is an instrument designed to measure the thermal energy which, in a heat-energy exchange circuit, is released by a liquid called a liquid energy transmitter Thermal.
A thermal energy meter is either a complete device or a combined instrument consisting of subassemblies (flow sensor, temperature sensor pair and calculator), as defined in section 1 of this Order, Point b, or a combination of both.
Symbols
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Requirements Specific
1. Operating Conditions
The operating conditions specified by the manufacturer are:
1.1. For liquid temperature: umax and umin;
For temperature differences: Dumax and Dumin;
With the following restrictions: Dumax/Dumin 10 and Dumin = 3 K or 5 K or 10 K.
1.2. For liquid pressure: the maximum positive internal pressure that the thermal energy meter can permanently support at the upper limit of the temperature.
1.3. For liquid flow rate: qs, qp, qi, qp values, and qi to satisfy the condition:
qp/qi 10.
1.4. For thermal energy: Ps.
2. Accuracy Classes
The following accuracy classes are defined for thermal energy meters: Class 1, Class 2, and Class 3.
3.
Maximum Tolerated Errors (EMT) Applicable to Full Thermal Energy Meters
For a complete thermal energy meter, the relative, positive, or negative TRAs expressed as per cent of the true value, Are given by the formula below, for all accuracy classes:
E = Ef + And + Ec
in which Ef, Et, Ec are the definitions in points 7.1 to 7.3 below.
4. Tolerable Effects of Magnetic Disturbances
or Electromagnetic
4.1. The instrument should not be influenced by static magnetic fields, nor by electromagnetic fields at the frequency of the power supply network.
4.2. The influence of an electromagnetic disturbance shall be such that the variation of the measurement result does not exceed the critical variation defined in section 4.3 below, or that the measurement result is indicated in such a way that it cannot Be interpreted as a valid result.
4.3. The critical variation for a complete thermal energy meter is the absolute value of the maximum permissible error applicable to this thermal energy meter.
5. Sustainability
After an adequate test has been performed taking into account a period estimated by the manufacturer, the device must meet the following criteria:
5.1. Flow sensors: after the durability test, the variation of the result of the measure relative to the result of the initial measurement must not exceed the critical variation.
5.2. Thermometric probes: after the durability test, the variation of the result of the measure with respect to the result of the initial measurement shall not exceed 0.1 ° C.
6. Enrolment on a thermal energy meter
A thermal energy meter has the following indications:
-accuracy class;
-limits of the extent of the flows;
-limits of the extent of the Temperatures;
-temperature range limits;
-where the flow sensor is installed: go or return;
-flow direction indication.
7. Subsets
Subset provisions can be applied to subsets made by one or more manufacturers.
When a thermal energy meter is composed of subsets, The appropriate essential requirements applicable to the meter are also applicable to subsets. In addition, the following provisions apply:
7.1. The relative EMT, Ef, applicable to the flow sensor, positive or negative, expressed per cent, for each accuracy class, is given by:
class 1: Ef = (1 + 0.01 x qp/q), with a maximum of 5 %;
class 2: Ef = (2 + 0.02 x Qp/q), with a maximum of 5 %;
class 3: Ef = (3 + 0.05 x qp/q), with a maximum of 5 %.
Ef applies to the volume or mass that transited through the flow sensor.
7.2. The relative EMT, And, for the pair of temperature sensors, positive or negative, expressed in percent, is given by:
And = (0.5 + 3 x Dumin/Du)
And applies to the difference in temperature issued by the probes.
7.3. The relative EMT for the positive or negative calculator, expressed in percent, is given by:
Ec = (0.5 + Dumin/Du)
Ec applies to the calculated thermal energy.
7.4. The critical variation for a subset of a thermal energy meter is equal to the corresponding absolute value of the EMT applicable to the subset.
7.5. Subset subscriptions:
Debit sensor:
Accuracy class;
Flow range limits;
Temperature range limits;
Meter nominal factor (ex. Litres/pulses) or corresponding output signal;
Indication of flow direction.
Temperature Sensor Pair:
Type Identification (ex. Pt 100);
Temperature Range Limits;
Temperature Gap Limits.
Calculator:
Type of temperature sensors that can be associated;
Temperature range limits;
Limits of Temperature difference;
Meter nominal factor required (ex. Litres/pulses) or corresponding input signal from the flow sensor;
Flow sensor location: go or return.
8. Commissioning
a) For residential metering, at least one Class 3 meter is sufficient.
(b) For commercial or light industrial metering, a Class 2 meter is at least Required.
(c) The operating conditions set out in points 1.1 to 1.4 of this annex shall be determined by the thermal energy distributor or the person legally designated for the installation of the meter, such Such that the meter is able to accurately measure expected or expected consumption.
Compliance Evaluation
The conformity assessment procedures among which the manufacturer Can choose:
B + F or B + D or H1.
A N N E X E M I-0 5
OTHER THAN LIQUID WEEKS
The relevant essential requirements of Annex I, requirements Of this Annex and the conformity assessment procedures listed in this Annex shall apply to measuring sets of liquids other than water for the determination of quantities (volumes or masses) of In a continuous and dynamic manner.
If applicable, the term " Volume " And symbol " L " Appearing in this Annex may read " Mass " And " Kg ".
Definitions
Meter:
An instrument designed for continuous measurement, memory and display, in measuring conditions, the amount of liquid passing through the transducer of Measuring in a closed and total charge line.
Calculator:
The portion of a meter that receives the output signals from one or more measuring transducers and, optionally, associated measuring instruments, and that displays the Measurement results
Associated measuring instrument:
Instrument connected to the calculator to measure certain quantities characteristic of the liquid (temperature, density, etc.), for the purpose of correcting or converting.
Conversion device:
A part of the calculator that, taking into account the characteristics of the liquid, measured using associated or stored measurement instruments, automatically converts:
-the volume of liquid measured in The conditions of measurement in a volume at the base or mass conditions, or
-the mass of the liquid measured under the conditions of the measurement in a volume at the measurement conditions or in a volume under the basic conditions.
Note. -A conversion device includes relevant related measurement instruments.
Basic conditions:
The specified conditions in which the quantity of liquid measured under the measurement conditions is converted.
Set Measuring:
Set including the meter itself and all devices necessary to ensure a correct measurement or to facilitate measurement operations.
Road Metering Ensemble:
Metering Set for the Refuelling of motor vehicles, small boats or small aircraft.
Self-service installation:
Installation that allows the customer to use a metering assembly to use a liquid intended for its use Personnel.
Self-service device:
A specific device that is part of a self-service installation and allows one or more metering sets to self-service in this installation.
Quantity Minimum measured (MMQ):
A smaller quantity of liquid for which the measurement is metrologically acceptable for the metering assembly.
Direct Indication:
Indication, in volume or mass, corresponding to the measurement Meter is physically able to measure.
Note. -The direct indication can be converted to an indication of another size using a conversion device.
Interruptible/Non-interruptible:
A metering assembly is considered to be interruptible or non-interruptible Depending on whether the liquid flow can or cannot be stopped easily and quickly.
Flow Range:
Range between Minimum Flow (Qmin) and Maximum Rate (Qmax).
Specific Requirements
1. Operating Conditions
The manufacturer must specify the operating conditions of the device, including:
1.1. The extent of flow rates, subject to the following conditions:
a) The extent of flow rates of a metering assembly shall be included in the flow range of each of its components, including the meter;
(b) The extent of the flow rates of a meter or A measurement set must meet the conditions set out in Table 1 below.
Table 1
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1.2. The properties of the liquid (s) to be measured by the instrument, indicating the name or type of liquid or its relevant characteristics, for example:
-the temperature range;
-the pressure range;
-the mass range Volume;
-the viscosity range.
1.3. The nominal value of ac power supply voltage or dc power voltage limits.
1.4. Basic conditions for converted values.
2. Tolerable Maximum Accuracy and Error Classes
2.1. For quantities equal to or greater than 2 litres, the maximum tolerated relative, positive or negative errors on the measurements are as follows:
Table 2
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2.2. For quantities less than 2 litres, the maximum tolerated errors on the measurements are as follows:
Table 3
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2.3. However, regardless of the quantity measured, the absolute value of the maximum permissible error is the greater of the following two values:
-the absolute value of the EMT indicated in Table 2 or Table 3, as the case may be;
-the value The EMT for the minimum measured quantity (Emin).
2.4. For minimum measured quantities greater than or equal to 2 litres, the following conditions apply to Emin:
Condition 1:
Emin 2 R, where R is the level of the flag device.
Condition 2:
Emin is given by the Formula: Emin = (2 x MMQ) x (A/100), where:
-MMQ is the minimum measured quantity;
-A is the numeric value specified on line A of Table 2.
For minimum measured quantities less than 2 litres, condition 1 above Applies and Emin is twice the value specified in Table 3, which is applied for row A in Table 2.
2.5. Indication converted:
In the case of a converted indication, the TRAs are those of row A in Table 2.
2.6. Conversion devices:
EMT for indications converted by a conversion device are equal to (A-B), A and B being the values shown in Table 2.
Parts of conversion devices that can be tested Separate:
a) Calculator:
EMT, positive or negative, for indications of liquid quantities applicable to the calculations is one tenth of the EMT indicated on line A of Table 2.
b) Associated measuring instruments:
The TRMs for associated measuring instruments, positive or negative, are given in Table 4 below.
Table 4
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These values apply to the indication of the characteristic quantities of the liquid displayed by the conversion device.
c) Accuracy for the calculation function:
EMTs, positive, or Negative, for the calculation of each quantity characteristic of the liquid equals two fifths of the value determined in b above.
2.7. The requirement under point 2.6 (a) applies for any calculation of quantities, not only for conversion.
3. Maximum Disrupted Effect
3.1. An electromagnetic disturbance must have one of the following effects on a metering assembly:
-the variation of the measurement result does not exceed the critical variation defined in point 3.2 below, or
-the indication of the Result of measurement presents a momentary variation which cannot be interpreted, stored or transmitted as a measurement result;
-in addition, in the case of a set of interruptible metering, this may also mean The impossibility of measuring, or if the variation of the measurement result is greater than the critical variation, the measurement set must be able to recover the result of the measurement just before the critical variation survives. Suspend throughput.
3.2. The critical variation is the largest of the EMT/5 values for a measured or Emin measured quantity.
4. Sustainability
After an appropriate test has been performed taking into account a period estimated by the manufacturer, for the meter and after the durability test, the variation of the result of the measurement with respect to the result of the Initial measurement shall not exceed the value set for the meters on line B of Table 2.
5. Dequation
5.1. For any measured quantity corresponding to the same measurement, the indications provided by various devices shall not show a deviation of more than one step when the devices have the same level. Where the devices have different steps, the difference shall not exceed the largest increment.
However, in the case of a self-service facility, the steps of the main indicator device of the metering assembly and the The level of the self-service device must be the same, and the results should not deviate from each other.
5.2. It should not be possible to divert the quantity measured under normal conditions of use, without this being evident.
5.3. Any proportion of air or gas that is not readily detectable in the liquid cannot lead to an error variation greater than:
-0.5 % for liquids other than potable liquids and for liquids of a lower viscosity or Equal to 1 mPa.s, or
-1 % for potable liquids and for liquids with a viscosity greater than 1 mPa.s.
However, the permitted variation is never less than 1 % of MMQ. This value is applicable in case of air or gas pockets.
5.4. Direct selling instruments.
5.4.1. A metering assembly for direct sale must be equipped with a means of resetting the display.
It should not be possible to divert the measured quantity.
5.4.2. The display of the quantity that serves as the basis for the transaction must be maintained until the parties to the transaction have accepted the measurement result.
5.4.3. The metering assemblies for direct sale must be interruptible.
5.4.4. The presence, regardless of the proportion, of air or gas in the liquid shall not lead to an error variation greater than the values specified in 5.3.
5.5. Road metering assemblies.
5.5.1. The display on road metering assemblies shall not be capable of being reset to zero during measurement.
5.5.2. The beginning of a new measurement must be inhibited until the display has been reset to zero.
5.5.3. When a metering assembly is equipped with a price display device, the difference between the specified price and the price calculated from the unit price and the specified quantity must not be greater than the price for Emin.
However, this difference is not required to be less than the smallest monetary unit.
6. Power supply failure
A metering assembly must either be equipped with a standby power supply to back up all the metering functions during the main device failure Power supply, or be equipped with a means of saving and displaying the present data, in order to allow the conclusion of the current transaction, as well as a means of stopping the flow at the time of the main device failure Power supply.
7. Commissioning
Table 5
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However, the manufacturer can specify a better accuracy class for Certain types of metering sets.
8. Units of Measure
The measured quantity must be in millilitres, cubic centimetres, litres, cubic metres, grams, kilograms or tonnes.
Conformity assessment
The conformity assessment procedures among which the manufacturer can choose are:
B + F or B + D or H1 or G.
A N N E X E M I-0 6
OPERATING INSTRUMENTS
AUTOMATIC
The relevant essential requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in Chapter I of this Annex shall apply to Automatic weighing instruments defined below to determine the mass of a body by using the action of gravity on that body.
Note. -Automatic weighing instruments for the motion weighing of on-road vehicles are subject to national effect control.
Definitions
Weighing instrument at Automatic operation:
An instrument that determines the mass of a product without the intervention of an operator and a predetermined automatic process program characteristic of the device.
Weighing Device-Labeller Automatic (tri-label):
Automatic weighing device that determines the mass of pre-assembled discrete loads (e.g. prepackages) or individual loads of bulk products.
Automatic Control Weigher:
Automatic-operating-label-labeller, dividing articles of different masses into several subsets according to the value of the difference between their mass and the Nominal sort point.
Weight Label:
Automatic-operating-label-labeller operating the weight label of each item.
Weight/Price Label:
Automatic-Operating Label-Labeller The labelling of weight and price information for each item.
Automatic Engravimetric Instrument:
Automatic Weighing Instrument which fills containers with a predetermined mass and Almost constant for a bulk product.
Discontinuous Totalizer (hopper totalizer):
Automatic Weighing Instrument that determines the mass of a bulk product by dividing it into discrete loads. The mass of each discrete load is determined sequentially and added. Each discrete load is then delivered in bulk.
Continuous Totalizer:
Automatic Weighing Instrument which continuously determines the mass of a bulk product on a conveyor belt without any systematic division of the Product and without interruption of the movement of the conveyor belt.
Railway scale:
Automatic weighing instrument equipped with a load receiving receiver with rails for the transport of road vehicles Iron.
Specific Requirements
Chapter I
Common requirements for all types of
automatic weighing devices
1. Operating Conditions
The manufacturer must specify the conditions assigned to operate the instruments, as follows:
1.1. For the measurement: the extent of measurement of the instrument in terms of maximum and minimum scopes.
1.2. For the influence sizes of the power supply:
-in the case of ac power supply: the rated supply voltage or the voltage limits;
-in case of dc power supply: the voltages Of rated and minimum power, or voltage limits.
1.3. For climatic and mechanical influence sizes:
-the temperature range, of which the minimum value is 30 ° C, unless otherwise indicated in the following chapters of this annex;
-mechanical conditions The use of instruments which are subject to a particular mechanical stress, for example the instruments integrated into vehicles. The mechanical environment classes provided for in Annex I, point 1.3.2 shall not apply.
1.4. For other influence sizes (if applicable):
-the operating speed (s);
-the characteristics of the product (s) to be weighed.
2. Tolerable Effect of Disturbances
Electromagnetic Environment
The required performance and critical variation are indicated in the appropriate paragraph of this annex, corresponding to each type of instrument.
3. Dequation
3.1. Means shall be provided to limit the effects of inclination, loading and operating speed in such a way that EMTs are not exceeded under normal operating conditions.
3.2. Adequate material handling facilities should be provided to allow the device to meet EMT during normal operation.
3.3. Any operator command interface must be clear and efficient.
3.4. The integrity of the display (if any) must be verified by the operator.
3.5. An appropriate zero-setting function should be provided to allow the device to meet EMT during normal operation.
3.6. Any output outside the measurement scope must be identified as such when printing is possible.
Compliance Evaluation
Conformity Assessment Procedures From which the manufacturer can choose:
For mechanical devices:
B + D or B + E or B + F or D1 or F1 or G or H1.
For electromechanical instruments:
B + D or B + E or B + F or G or H1.
For devices Electronics or instruments with software:
B + D or B + F or G or H1.
Chapter II
Automatic-operating-labellers
1. Accuracy Classes
1.1. The instruments are divided into primary categories designated by X or Y as indicated by the manufacturer.
1.2. These categories are subdivided into four accuracy classes specified by the manufacturer:
-XI, XII, XIII and XIV (or XIIII), and
-Y (I), Y (II), Y (a), and Y (b)
2. Category X Instruments
2.1. Category X applies to the instruments used to verify the conformity of prepackages to the provisions of Council Directive 75 /106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the Volume preconditioning of certain pre-packed liquids and Council Directive 76 /211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to mass or volume preconditioning of Some prepackaged products.
These instruments are auto-operating control weights.
2.2. The accuracy classes are supplemented by a factor (x) which quantifies the maximum tolerated deviation as specified in section 4.2. The manufacturer must specify the factor (x), (x) being 2 and having the form: 1 x 10k, 2 x 10k or 5 x 10k, where k is a negative integer or zero.
3. Category Y Instruments
Category Y applies to all other automatic labellers, including weight labels and weight/price tags.
4. Maximum Tolerated Errors
4.1. Table 1 below gives the maximum tolerated average errors for category X instruments and maximum tolerated errors for category Y instruments, based on the net charge.
Table 1
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4.2. Standard deviation:
The maximum permissible value for the standard deviation of an X-class instrument (x) is the result of multiplying the factor (x) by the value shown in Table 2 below.
Table 2
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For Classes XI and XII, (x) must be less than 1.
For class XIII, (x) must not be greater than 1.
For class XIV (or XIIII), (x) must be greater than 1.
4.3. Verification scale for single-level instruments
Table 3
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4.4. Verification scale for multi-level instruments.
Table 4
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5. Measurement Scope
When specifying the measurement scope for Class Y devices, the manufacturer must take into account that the minimum scope should not be less than:
Class Y (I): 100 e ;
Class Y (II): 20 e for 0.001 g e 0.05 g, and 50 e for 0.1 g e;
Class Y (a): 20 e;
Class Y (b): 10 e;
Balances used for sorting, for example, postal scales and waste scales: 5 e.
6. Dynamic tuning
6.1. The dynamic adjustment device must operate on a load range specified by the manufacturer.
6.2. When the scooter is equipped with a dynamic adjustment device which compensates for the dynamic effects of the moving load, it must be neutralized for operation outside the load range and must be able to be Protected.
7. Performance in case of
influence factors and electromagnetic disturbances
7.1. Maximum tolerated errors in the presence of an influence factor are:
7.1.1. For category X devices:
-in automatic operation, the values shown in Tables 1 and 2;
-for non-automatic static weighing, the values shown in Table 1;
7.1.2. For category Y devices:
-for each automatic load, the values shown in Table 1;
-for non-automatic static weighing, the values shown for category X in the Table 1.
7.2. The critical variation due to a perturbation is an interval of verification.
7.3. Temperature range:
-for classes XI and Y (I), the minimum range is 5 ° C;
-for classes XII and Y (II), the minimum range is 15 ° C.
Chapter III
Gravimetric filling instruments Automatic
1. Accuracy Classes
1.1. The manufacturer must specify the reference accuracy class Ref (x) and the operating accuracy class (s) X (x).
1.2. An instrument type is designated by a reference accuracy class, Ref (x), corresponding to the best possible accuracy for instruments of this type. After installation, the individual instruments are designated for one or more operating accuracy classes, X (x), taking into account the specific products to be weighed. The class designation factor (x) must be less than or equal to 2 and the form 1 x 10k, 2 x 10k, or 5 x 10k, where k is a negative integer or zero.
1.3. The reference accuracy class, Ref (x), is applicable for static loads.
1.4. For the operating accuracy class X (x), X is a relationship between the accuracy and the load weight, and (x) is a multiplier of the error limits specified for class X (1) in 2.2.
2. Maximum Tolerated Errors
2.1. Static weighing error.
2.1.1. In the case of static charges, under the assigned operating conditions, the absolute value of maximum permissible errors for the reference accuracy class Ref (x) is equal to 0.312 times the maximum permissible deviation of each fill Relative to the average shown in Table 5, multiplied by the class designation factor (x).
2.1.2. For devices for which the filling may have more than one load (ex. : instruments with cumulative or associative combinations), the absolute value of maximum permissible errors for static loads is the accuracy required for the filling as indicated in 2.2 (and not the sum of the maximum deviations Eligible for individual expenses).
2.2. Maximum permissible deviation from the average fill.
Table 5
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Note : The difference calculated for each fill relative to the mean can be adjusted to take into account the effect of particle size of the material.
2.3. Error with respect to preset value (adjustment error).
For devices for which it is possible to predetermine a fill weight, the maximum difference between the pre-determined and the average weight of the Fills must not exceed 0.312 times the maximum allowable deviation of each fill from the average, as shown in Table 5.
3. Performance under
influence factors and electromagnetic disturbances
3.1. Maximum tolerated errors in the presence of a factor of influence are those indicated in 2.1.
3.2. The critical variation due to disturbance is a change in the indication of the static weight equal to the EMT specified in point 2.1, calculated for the minimum nominal filling, or a variation which would have an equivalent effect on the filling in The case of instruments performing multi-load filling. The calculated critical variation is rounded to the nearest higher (d) level.
3.3. The manufacturer must specify the minimum nominal fill value.
Chapter IV
Discontinuous Totalizers
1. Accuracy Classes
The instruments are divided into four accuracy classes: 0.2, 0.5, 1, and 2.
2. Maximum Tolerated Errors
Maximum tolerated errors are given in Table 6 below.
Table 6
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3. Summation Level
The totalization step (dt) must be greater than or equal to 0.01 % of the maximum scope and less than or equal to 0.2 % of the maximum scope.
4. Minimum Total Load (min)
The minimum total load (min) must not be less than the load for which the EMT is equal to the totalization step (dt), or less than the minimum load specified by the Manufacturer.
5. Zero Setting
Devices that do not perform the tare after each unload must be equipped with a zeroing device. Their automatic operation must be made impossible if the indication of zero varies from:
-1 dt on instruments equipped with an automatic zero-setting device;
-0.5 dt on instruments equipped with a zero-setting device Semi-automatic or not automatic.
6. Operator Interface
Operator adjustments and reset function must be made impossible during automatic operation.
7. Printing
On instruments equipped with a printing device, the reset of the total must be made impossible until the total is printed. The printing of the total must occur if the automatic operation is suspended.
8. Performance under
influence factors and electromagnetic disturbances
8.1. The TRAs in the presence of an influence factor are as shown in Table 7 below.
Table 7
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8.2. The critical variation due to disturbance is a totalization step for any weight indication and total memory.
Chapter V
Continuous Totalizers
1. Accuracy Classes
The instruments are divided into three accuracy classes: 0.5, 1, and 2.
2. Measurement Scope
2.1. The manufacturer must specify the extent of measurement, the ratio between the minimum net load on the weighing unit and the maximum range, and the minimum total load.
2.2. The minimum aggregate load, min, must not be less than:
-800 d for class 0.5,
-400 d for class 1,
-200 d for class 2,
where d is the aggregation level of the general totalization device.
3. Maximum Tolerated Errors
Maximum tolerated errors are given in Table 8 below:
Table 8
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4. Tape Speed
The tape speed must be specified by the manufacturer. For instruments at constant speed and for variable speed instruments equipped with manual control of speed, the speed shall not vary by more than 5 % of the nominal value. The product must not have a different speed than the speed of the tape.
5. General totalization device
It should not be possible to reset the generalization device to zero.
6. Performance under
influence factors and electromagnetic disturbances
6.1. MTRs in the presence of an influence factor, for a load not less than min, are 0.7 times the appropriate value given in Table 8, rounded to the nearest totalization step (d).
6.2. The critical variation due to disturbance is equal to 0.7 times the appropriate value given in Table 8, for a load equal to min, for the designated class of the continuous totalizer, rounded up to the top level (d) interval.
Chapter VI
Automatic rail bridges
1. Accuracy Classes
The instruments are divided into four accuracy classes: 0.2, 0.5, 1, and 2.
2. Maximum Tolerated Errors
2.1. EMT for the motion weighing of a single car or whole train is calculated from the values shown in Table 9.
Table 9
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2.2. The TRAs for the movement of clinging or unhooked cars are equal to the greater of the following values:
-the value calculated in accordance with Table 9, rounded to the nearest level;
-the calculated value In accordance with Table 9, rounded to the nearest level, for a weight equal to 35 % of the maximum weight of the car (as shown on the device's identifying indications);
-a step (d).
2.3. EMT for the moving weighing of a train shall be equal to the greater of:
-the value calculated in accordance with Table 9, rounded to the nearest interval;
-the value calculated in accordance with Table 9, for the Weight of a single car equal to 35 % of the maximum weight of the car (indicated on the instrument's identifying indications), multiplied by the number of reference cars (not exceeding 10) of the train and rounded to the nearest level;
-one Step (d) for each train carriage, not exceeding 10 d.
2.4. When weighing car carriages, errors of 10 % or more of the weighing results obtained in one or more parts of the train may exceed the maximum permissible errors indicated in 2.2, but shall not exceed twice These maximum tolerated errors.
3. Echelon (d)
The relationship between the accuracy class and the step level is as shown in Table 10.
Table 10
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4. Measurement Scope
4.1. The minimum capacity shall not be less than 1 t or greater than the result of dividing the minimum weight of the car by the number of partial weights.
4.2. The minimum car weight must not be less than 50 d.
5. Performance under
influence factors and electromagnetic disturbances
5.1. The maximum tolerated errors in the presence of an influence factor are as shown in Table 11.
Table 11
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5.2. The critical variation due to disturbance is one step.
A N N E X E M I-0 7
TAXIMETERS
The relevant requirements of Annex I, the specific requirements of this Annex and the Conformity assessment procedures listed in this annex apply to taximeters.
Definitions
Taximeter:
A device coupled to a signal generator (1) to form a Measuring instrument.
The device measures the duration, calculates the distance on the basis of a signal produced by the generator of distance signals. In addition, it calculates and displays the price to be paid for a trip based on the calculated distance or the measured duration of the trip.
(1) The distance signal generator and thus the complete measuring instrument installed in the vehicle do not Does not fall within the scope of this appendix.
Price:
The total amount due for a trip, based on an initial support package or the length or duration of the trip. The price does not include any additional service surcharge.
Training change rate:
Speed obtained by dividing the hourly rate by the value of the rate at the distance.
Normal computation mode S (simple Application of the tariff):
Calculation of the price based on the application of the hourly rate below the speed of change of training and the application of the rate at distance beyond the speed of change of training.
Normal calculation mode D (dual tariff application):
Calculation of the price based on the simultaneous application of the hourly rate and the rate at the distance for the whole trip.
Operating positions:
Different modes in which a taximeter operates In accordance with its purpose. The operating positions are distinguished by the following indications:
" Free " : the operating position in which the price calculation is disabled;
" Busy " : the operating position in which the calculation of the price of the journey is carried out on the basis of a possible initial charge and the rate at the distance or the hourly rate;
" Payable " : the operating position in which the path price is specified and at least the calculation of the duration price is disabled.
Specific requirements
1. The taximeter shall be designed to calculate the distance and measure the duration of a trip.
2. The taximeter shall be designed to calculate and display the price which increases in equal increments to the resolution fixed by the Member State in the position " Busy ", and show the final price of the path in the position" Payable ".
3. The taximeter must be able to apply the normal modes of calculation S and D. The choice between these calculation methods must be possible thanks to a safe adjustment.
4. A taximeter must be able to provide the following data through one or more appropriate secure interfaces:
-operating position: " Free, " Busy " Or " Payable " ;
-totaliate values according to point 15.1 of this annex;
-general information: distance signal generator constant, date of securing, taxi identification, real time, rate identification ;
-price information for a trip: total price requested, price calculation, expense mark-up, date, departure time, arrival time, distance travelled;
-rate information: parameter (s): rate (s).
La National legislation may require that certain devices be connected to the interface or interfaces of the taximeter. In this case, the operation of the meter must be able to be made automatically impossible by a safety device when the required device is not connected or does not function normally.
5. In this case, it must be possible to adjust a meter according to the constant of the distance signal generator to which it is intended to be connected and to secure the adjustment.
6. Operating conditions:
6.1. The applicable mechanical environment class is the M3 class.
6.2. The manufacturer specifies the conditions of operation of the instrument, in particular:
-a temperature range of at least 80 ° C for the climate environment;
-the limits of the dc power supply for which The device has been designed.
7. Maximum Tolerated Errors (EMT):
EMT, excluding any errors due to taximeter installation in a taxi, are:
-for the elapsed time: 0.1 %, with minimum EMT value: 0.2 s;
-for distance Travelled: 0.2 %, with the minimum value of the EMT: 4 m;
-for the calculation of the price: 0.1 %, with the minimum value of the EMT: rounded up, the price level.
8. Tolerable Effect (Electromagnetic Immunity):
8.1. The applicable electromagnetic class is the E3 class.
8.2. The EMTs defined in point 7 shall also be complied with in the presence of electromagnetic disturbance.
9. Power supply failure:
In the event of a decrease in the power supply voltage to a value less than the lower operating limit specified by the manufacturer, the taximeter must:
-continue to operate Correct or resume correct operation without losing the existing data before the voltage drop if it is momentary, that is, if it is due to the engine restart;
-stop the current measure and return to the Position " Free " If the voltage drop lasts longer.
Other requirements
10. The compatibility conditions between the meter and the distance signal generator shall be specified by the manufacturer of the taximeter.
11. If the price is increased because of an additional service, registered by the driver using a manual order, this supplement must be excluded from the price displayed. In this case, however, the meter can temporarily display the price including the supplement.
12. If the price is calculated according to calculation mode D, the taximeter can have an additional display mode in which only the total distance and the total duration of the trip are displayed in real time.
13. All values displayed to the passenger must be appropriately identified. These values and their identification must be clearly legible day and night.
14. Securing:
14.1. If the price to be paid or the measures to be taken against fraudulent use can be influenced by the choice of functionality from a set of pre-programmed or freely determined data, it must be possible to protect Instrument settings and data introduced.
14.2. Existing protection options in a taximeter should allow for separate protection of the settings.
14.3. The provisions of point 8.3 of Annex I shall also apply to
. Indications:
15.1. A taximeter must be equipped with totalizers that cannot be reset for all of the following values:
-the total distance travelled by the taxi;
-the total distance travelled by the taxi in position " Busy " ;
-the total number of races;
-the total amount of the applied supplements;
-the total amount of the race prices.
Total values must include the values saved when the power is broken In accordance with point 9 of this annex.
15.2. When disconnected from the electrical energy source, a taximeter must be used to keep the total values for a one-year period for transfer to another media.
15.3. Appropriate measures should be taken to prevent the display of tabulated values from being used to deceive the client.
16. Automatic rate change is allowed based on:
-the distance of the trip;
-the duration of the trip;
-the time of day;
-the date;
-the day of the week.
17. If taxi characteristics are important for the correct operation of the taxi meter, the taxi must include means to protect the taximeter's connection to the taxi in which it is installed.
18. For the purpose of post-installation testing, the meter must be capable of testing the accuracy of time and distance measurements separately and the accuracy of the calculations.
19. A taximeter and its installation instructions specified by the manufacturer shall be so designed that, in the event of installation in accordance with the manufacturer's instructions, fraudulent modifications of the measurement signal representing the Distance travelled is sufficiently prevented.
20. The general essential requirement for fraudulent use must be satisfied in such a way that the interests of the client, the driver, the driver's employer and the tax authorities are protected.
21. A taximeter must be designed so that it can, without adjusting, respect maximum tolerated errors for a period of one year of normal use.
22. The meter must be equipped with a real time clock, with which the time of day and the date are kept, either of these data or both of which can be used to automatically change the tariff. The requirements applicable to the real time clock are:
-the memorization of time must have an accuracy of 0.02 % or better;
-the possibility of correcting the clock must not exceed 2 minutes per week. Daylight Saving Time must be done automatically;
-any correction, whether automatic or manual, during a race must be prevented.
23. The distance and elapsed time values, when displayed or printed, must be expressed in the following units:
-distance travelled: in kilometres;
-elapsed time: seconds, minutes, or hours, depending on what Is best, taking into account the necessary resolution and the need to avoid misunderstandings.
However, the distance may be expressed in miles for the taximeters exclusively reserved in the United Kingdom and Ireland, up to the date that Shall be fixed by these Member States in accordance with Article 1 (b) of Directive 80 /181/EEC, as last amended by Directive 89 /617/EEC.
Conformity assessment
Procedures For conformity assessment, the manufacturer may choose:
B + F or B + D or H1.
A N N E X E M I-0 8
PHYSICAL MEASURES
Chapter I
Materialized Measures
The relevant essential requirements of Annex I, the specific requirements of this chapter and the conformity assessment procedures listed in this chapter apply to defined length measures defined
However, the requirement for a copy of the declaration of conformity can be interpreted as applying to a set or batch rather than to each individual instrument.
Definition
Materialized measure of length:
A measurement instrument with scale benchmarks whose distances are given in legal length units.
Specific requirements
1. Reference conditions
1.1. For ribbons with a length greater than or equal to five metres, the maximum tolerated errors (EMT) shall be observed when a pulling force of fifty newtons, or other force values specified by the manufacturer, and marked in On the tape, are applied; in the case of rigid or semi-rigid measurements, no traction force is required.
1.2. The reference temperature is 20 ° C, except for a different value specified by the manufacturer and marking corresponding to the measurement.
2. Maximum Tolerated Errors
Maximum tolerated errors, positive or negative in millimetres, between two non-consecutive scale marks are given by the formula: a + bL, where:
-L is the round length per metre Immediately above;
-a and b are given in Table 1 below.
When a terminal interval is limited by a surface, the EMT for any distance starting at this point is increased by the c value shown in Table 1.
Table 1
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Gauge ribbons can also be classes I or II, in which case, for Any length between two scale marks, one on the probe and the other on the tape, the maximum tolerated errors are 0.6 mm when the application of the defined formula above gives a value less than 0.6 mm.
Maximum errors Tolerance for the length between two consecutive scales of the scale and the maximum tolerated difference between the lengths of two consecutive intervals are shown in Table 2 below.
Table 2
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In the case of a bending meter, the joint between two elements must not cause any additional error to those Above, exceeding 0.3 mm for Class II and 0.5 mm for Class III.
3. Materials
3.1. Materials used for long-range measurements shall be such that variations in length due to temperature variations up to 8 ° C in relation to the reference temperature do not exceed EMT. This rule does not apply to Class S and Class D measures where the manufacturer anticipates that thermal expansion corrections should be made to the readings found, if necessary.
3.2. Measurements made with materials whose dimensions can materially change as a result of a significant variation in relative humidity can only belong to classes II or III.
4. Markings
The face value must be marked on the measure. The graduated scales per millimetre must be encrypted at each centimeter and measurements with a step greater than 2 cm must have all their tags encrypted.
Compliance Evaluation
The conformity assessment procedures from which the manufacturer can choose are:
F1 or D1 or B + D or H or G.
Chapter II
Capacity Measures to Serve
Requirements The specific requirements of Annex I, the specific requirements of this Chapter and the conformity assessment procedures listed in this Chapter apply to the capacity measures defined below.
However, the requirement For a copy of the declaration of conformity may be interpreted as applying to a set or batch rather than to individual instruments. Similarly, the requirement that the device must carry information about its accuracy is not applicable.
Only liquid capacity measures are regulated in France. These measures are characterized by the following:
-they are transfer measures within the meaning defined below;
-they are metal and food-use;
-they are cylindrical in shape and their nominal height
other measures of capacity to be used may nevertheless be the subject of the conformity assessment procedures provided for by the French bodies notified to that effect.
Definitions
Measurement of capacity to be used:
A measure of capacity (such as a drinking glass, a bowl or a sewing thread) designed to determine a given volume of a liquid (other than a drug product) Sold for immediate consumption.
Measure:
A measure of capacity to be used with a line indicating rated capacity.
Measuring on board:
A measure of capacity to be used for which the internal volume is equal to the Rated capacity.
Transfer Measure:
A measure of capacity to be used from which the liquid is transferred to another container before its consumption.
Capacity:
Inner Volume for Measurements at the Edge and Volume To a fill axis system for the related measures.
Specific requirements
1. Reference conditions
1.1. Temperature: The reference temperature for the capacity measure is 20 ° C.
1.2. Correct indication position: placed freely on a horizontal surface.
2. Maximum Tolerated Errors
EMTs are given in Table 1.
Table 1
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3. Materials
The capacity measures to be used must consist of a material that is sufficiently rigid and of stable dimensions so that the capacity remains within the limits of the EMTs.
4. Shape
4.1. The transfer measures shall be designed so that a change in content equal to the EMT shall lead to a change in the level of at least 2 mm on the edge or the fill axis, as the case may be.
4.2. Transfer measurements shall be designed so as not to prevent the flow of all the measured liquid.
5. Mark
5.1. The rated capacity declared must be marked clearly and indelibly on the measure.
5.2. The capacity measures to be used may carry up to three clearly recognisable capacity marks, none of which should be confused with another.
5.3. All fill marks must be sufficiently clear and durable to ensure that TRAs are met during use.
Compliance Evaluation
Evaluation Procedures Of the compliance that the manufacturer can choose are:
A1 or F1 or D 1 or E1 or B + E or B + D or H.
A N N E X E M I-0 9
DIMENSIONAL MEASUREMENT INSTRUMENTS
Requirements Relevant requirements of Annex I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex apply to the types of defined dimensional measuring instruments Below.
The length measurement instruments, as defined below, are not subject to metrological control in France, but the conformity assessment procedures may be carried out by the French authorities Notified for this purpose.
Definitions
Length Measurement Instrument:
A measuring instrument for determining the length of cordage-type materials (e.g., textiles, tapes, etc. Cables) during the advance movement of the product to be measured.
Surface Measurement Instrument:
A measuring instrument for determining the surface of irregular shape objects, such as leather objects.
Instrument of Measurement Multidimensional:
Measuring instrument used to measure edges (length, height, width) of the smallest rectangular parallelepiped enclosing a product.
Chapter I
Common requirements common to all
dimensional measuring instruments
Electromagnetic immunity
1. The effect of an electromagnetic disturbance on a dimensional measuring instrument must be such that:
-the variation of the measurement result does not exceed the critical variation defined in point 2 below, or
-it is impossible To perform a measurement, or
-the result of the measurement presents momentary variations that cannot be interpreted, stored or transmitted as a measurement result, or
-the result of the measurement presents variations Large enough to be noticed by everyone who is interested in the measurement result.
2. The critical variation is equal to one step.
Compliance Evaluation
The Conformity assessment procedures from which the manufacturer can choose are:
For mechanical or electromechanical instruments:
F1 or E1 or D1 or B + F or B + E or B + D or H or H1 or G;
For electronic devices Or instruments with software:
B + F or B + D or H1 or G.
Chapter II
Length Measuring Instruments
1. Characteristics of the Product to Measure
Textiles are characterized by the characteristic factor K. This factor, which takes into account the extensibility and weight per unit area of the measured product, is defined by the Formula:
K = x (GA + 2.2 N/m²)
where:
-is the relative elongation of a 1 metre wide tissue sample subjected to a 10 N tension force;
-GA is the weight per unit area of a fabric sample in N/m².
2. Operating conditions
2.1. The manufacturer specifies the limits for the measurable dimensions and the K factor. The ranges of the K factor are shown in Table 1.
Table 1
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2.2. When the measured object is not transported by the measuring instrument, the manufacturer specifies the allowable limits for its travel speed.
2.3. If the result of the measurement depends on the thickness, surface condition and presentation of the product (e.g. on a large drum or heap), the manufacturer specifies the corresponding limitations.
3. Maximum Tolerated Errors (EMT)
EMTs are specified in Table 2.
Table 2
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where Lm is the minimum measurable length, that is, the smallest length specified by the manufacturer for which the device is intended to be used.
The true length of the different types of materials Should be measured using appropriate instruments (e.g., one metre tape). For this, the material to be measured should be placed on a suitable medium (for example, an adequate table) flat and unstretched.
4. Another requirement
The device must be able to measure the product in its unstretched state, taking into account the extensibility for which the device is designed.
Chapter III
Measuring Instruments Of surface
1. Operating conditions
1.1. Scope:
The manufacturer specifies limits for measurable dimensions.
1.2. Product status:
The manufacturer must specify the possible limitations of the instruments due to the speed, thickness, and condition of the surface, if relevant, of the product.
2. Maximum Tolerated Errors (EMT)
In absolute terms, the EMT is 1.0 %, but not less than 1 dm².
Other requirements:
3. Product Overview
Removing or stopping the product during measurement should not lead to a measurement error or the display should be neutralized.
4. Echelon
Instruments must have a level of 1.0 dm². In addition, it must be possible to have a scale of 0.1 dm² for testing purposes.
Chapter IV
Multidimensional Measuring Instruments
1. Operating conditions
1.1. Scope:
The manufacturer specifies limits for measurable dimensions.
1.2. Minimum dimension:
The lower limit of the minimum dimension based on the scale is shown in Table 1.
Table 1
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1.3. Product displacement rate:
The manufacturer specifies the limits allowed for the speed of moving the product.
2. Maximum Tolerated Errors (EMT)
In absolute value, the EMT is equal to 1 d.
A N N E X E M I-1 0
FAILURE GAS ANALYST
The relevant requirements of the schedule I, the specific requirements of this Annex and the conformity assessment procedures listed in this Annex shall apply to exhaust gas analyzers defined below for inspection and professional maintenance In-use motor vehicles.
Definitions
Exhaust gas analyzer:
A measuring instrument for determining the density of certain components of an exhaust gas Spark ignition motor vehicle at the moisture level of the tested sample.
Lambda (l):
dimensionless parameter, representative of the combustion efficiency of an engine in terms of air/fuel ratio in gases Exhaust. It is determined using a standard reference formula.
Gases measured and calculated parameter
The measured gas components are: carbon monoxide (CO), carbon dioxide (CO2), Oxygen (O2) and hydrocarbons (HC). The hydrocarbon content shall be expressed in the equivalent of n-hexane (C6H14), measured according to the absorption principle in the near infrared.
The volumetric titles of the gas components are expressed per cent (% vol.) for CO, CO2 and O2 and Parts per million (ppm vol.) for HC.
In addition, an exhaust gas analyzer calculates the lambda parameter from the volume titles of the exhaust gas components.
Specific requirements
1. Device Classes
Two classes, 0 and I, are defined for exhaust gas analyzers. The minimum ranges of measurement relevant to these classes are shown in Table 1.
Table 1
Classes and Extent of Measurement
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2. Operating Conditions
The operating condition values are specified by the manufacturer as follows:
2.1. For climatic and mechanical influence sizes:
-the temperature range of at least 35 ° C for the climate environment;
-the applicable mechanical environment class is the M1 class.
2.2. For power-influence quantities:
-the voltage and frequency range for ac power;
-the limits of DC power.
2.3. For ambient pressure: the minimum and maximum values respecting the two classes: Pmin 860 hPa; Pmax 1,060 hPa.
3. Maximum Tolerated Errors (EMT)
3.1. For each of the titles measured, the maximum tolerated errors in the assigned operating conditions correspond to the largest, in absolute value, of the two values shown in Table 2. The values expressed as % vol. or ppm vol. Correspond to the measured quantities and the values per cent correspond to percentages of the true value measured.
Table 2
EMT
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3.2. EMTs for the calculation of lambda are equal to 0.3 %, in addition or less. The value conventionally true shall be calculated in accordance with the formula defined in point 5.3.7.3 of Annex I to Directive 98 /69/EC of the European Parliament and of the Council on measures to be taken against air pollution by emissions from Motor vehicles and amending Directive 70 /220/EEC.
For this purpose, the values indicated by the instrument are used for the calculations.
Disrupted Effect
4. For each volume title measured by the instrument, the critical variation is equal to the absolute value of the EMT for the parameter concerned.
5. An electromagnetic disturbance may have the following effects:
-the variation of the measurement result does not exceed the critical variation defined in point 4 of this annex, or
-the result of the measurement is indicated in such a way That it cannot be considered a valid result.
Other Requirements
6. The resolution must be equal to the values shown in Table 3 or higher of an order of magnitude.
Table 3
Resolution
You can view the table in OJ
No 120, 24/05/2006 Text number 9
The lambda parameter must be displayed with a resolution of 0.001.
7. The standard deviation of 20 measurements shall not exceed one third of the absolute value of the EMT for each applicable gas volume title.
8. For CO, CO2 and HC measurements, the instrument, including the specific gas circulation system, shall indicate 95 % of the final value determined with gas for calibration within 15 seconds of a change from a gas to Zero, for example, fresh air.
For the O2 measurement, the instrument used under similar conditions shall indicate a value that deviating from less than 0.1 % vol. of zero within 60 seconds of the passage of fresh air to a gas Without oxygen.
9. The components of exhaust gases other than components whose values are measured shall not affect the results of the measurement of more than the absolute value of the EMT when these components are present in the maximum quantities :
-6 % vol. CO;
-16 % vol. CO2;
-10 % vol. O2;
-5 % vol. H2;
-0.3 % vol. NO;
-2 000 ppm vol. HC (as n-hexane);
-water vapour until saturation.
10. An exhaust gas analyzer shall have an adjustment device for the reset, gas calibration and internal adjustment. The reset and internal adjustments must be automatic.
11. In the case of an automatic or semi-automatic adjustment device, the instrument must be incapable of performing a measure until the adjustments have been made.
12. An exhaust gas analyzer shall detect the residues of hydrocarbons in the gas circulation system. It must be impossible to measure if the hydrocarbon residues present above all measurements exceed 20 ppm vol.
13. An exhaust gas analyzer shall have a device that automatically highlights any malfunction of the oxygen channel sensor due to its wear or tear on the connection line.
14. When the exhaust gas analyzer is capable of handling different fuels (for example, petrol or LPG), it must be possible to select the appropriate coefficients for the calculation of lambda, without ambiguity concerning the choice of the Appropriate formula.
Compliance Evaluation
The conformity assessment procedures among which the manufacturer can choose are:
B + F or B + D or H1.
Done in Paris, April 28, 2006.
For the Minister and by delegation:
The Director of Regional Action,
for Quality and Industrial Security,
N. Homobono
