Source: https://www.global-regulation.com/translation/austria/2994828/2016-meter-regulation-and-amendment-of-the-regulation-on-mutual-recognition-in-the-field-of-measurement-and-calibration-system%252c-dispensing-vascular-.html
Timestamp: 2018-06-23 13:37:16
Document Index: 259550124

Matched Legal Cases: ['§ 2', '§ 3', '§ 4', '§ 5', '§ 13', '§ 14', '§ 6', '§ 8', '§ 9', '§ 8', '§ 10', '§ 6', '§ 11', '§ 14', '§ 5', '§ 12', '§ 17', '§ 18', '§ 20', '§ 19', '§ 21', '§ 22', '§ 24', '§ 25', '§ 26', '§ 12', '§ 6', '§ 31', '§ 23', '§ 18', '§ 14', '§ 14', '§ 19', '§ 49', '§ 1', '§ 2', '§ 3', '§ 3', '§ 18', '§ 40', '§ 2', '§ 3', '§ 4', '§ 49', '§ 1', '§ 58', '§ 58', '§ 3', '§ 14', '§ 6', '§ 7']

Machine Translation of "2016 Meter Regulation And Amendment Of The Regulation On Mutual Recognition In The Field Of Measurement And Calibration ..." (Austria)
2016 Meter Regulation And Amendment Of The Regulation On Mutual Recognition In The Field Of Measurement And Calibration System, Dispensing Vascular Regulation, The Calibration Accreditation Regulation And...
Original Language Title: Messgeräteverordnung 2016 und Änderung der Verordnung über die gegenseitige Anerkennung auf dem Gebiet des Maß- und Eichwesens, der Schankgefäßeverordnung, der Eich-Zulassungsverordnung und der ...
Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2016_II_31/BGBLA_2016_II_31.html
31 Ordinance of the Federal Minister for science, research and economy, where a regulation on measuring devices is adopted (meter regulation 2016) and the regulation on mutual recognition in the field of measurement and calibration system, dispensing vascular regulation, the calibration accreditation regulation and the regulation concerning the recognition of calibration technical assessments be changed
Meter regulation 2016
Amendment of the regulation on mutual recognition in the field of measurement and calibration system
Amendment of the dispensing container regulation
Change the calibration approval regulation
Amendment of the regulation on the recognition of calibration technical assessments
Ordinance of the Federal Minister for science, research and industry relating to gauges (gauge regulation 2016)
On the basis of section 18 Z 4 the measurement and calibration Act (MEG), Federal Law Gazette No. 152/1950, as last amended by Federal Law Gazette I no. 148/2015 is prescribed:
1. (1) lays down the requirements this regulation, which is required for the following measuring devices for first-time placing on the market or for the initial entry into service for measuring tasks, provided that they are subject to calibration:
1. water meters intended for the measurement of volume of clean cold or hot water;
2. gas meter and Correctors;
3. electrical energy meters work;
4. heat meters;
5. measuring systems for the continuous and dynamic measurement of quantities of liquids other than water;
6 automatic weighing instruments;
7 meter;
8 Maß incarnations (embodied length and capacity serving measures);
9 meters for the measurement of length and their combinations.
(2) the conformity of a measuring instrument is under this regulation are found then these instruments are considered first calibrated and may in the scope of the provisions of the measures and calibration Act used or kept.
§ 2. The instruments referred to in article 1, paragraph 1 are subject to the requirements for electromagnetic immunity in the sense of article 2 paragraph 3 of the directive of 2014/30/EC on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast), OJ No. L 96 of the 29.03.2014 S. 79.
§ 3. The purposes of this regulation, the term may refer to:
1 "Instrument": any device or system with a measurement function that in article 1, paragraph 1 is;
2. "Sub-Assembly": one as such construction unit mentioned in the calibration regulations, belonging to a measuring device pursuant to section 1 para 1, which operates independently and a) together with other sub-assemblies with which it is compatible, or b) represents a measuring instrument together with a measuring instrument with which it is compatible;
3. "legal metrological control": the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety and order, protection of the environment, the levying of taxes and duties, protection of consumers and fair trade;
4. "normative document": a document containing technical specifications, drawn up by the international organization of legal metrology (OIML);
5. "Making available on the market": any payment or free of charge of a meter for distribution or use on the Union market in the course of a business;
6 "placing on the market': the first making available of a gauge on the Union market;
7 "Operation": the first use of an instrument intended for the end user for the intended purpose;
8 'Manufacturer': any natural or legal person, which produces a meter or develop or manufactured and marketed this device under their own name or their own trade mark or take for their own purposes in operation;
9 'authorised representative': any natural or legal person established in the European Union, in writing, appointed by a manufacturer to perceive certain tasks on his behalf;
10 "importer": each natural or legal person established in the European Union, presents a meter from a third country on the Union market;
11 "Dealer": any natural or legal person in the supply chain, providing a gauge on the market, with the exception of the manufacturer or the importer;
12 "Economic operators": the manufacturer, the agents, the importer and the Distributor;
13 'technical specification': a document in which the technical requirements are prescribed, an instrument must, meet
14. 'harmonised standard': a harmonized standard within the meaning of article 2 paragraph 1, lit. c of the Regulation (EU) No. 1025 / 2012 to the European standardisation, amending Directives 89/686/EEC and 93/15/EEC of the Council and of the directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Decision 87/95/EEC of the Council and decision No 1673/2006/EC of the European Parliament and of the Council OJ No. L 316 of the 14.11.2012 S. 12;
15 "Accreditation": an accreditation within the meaning of article 2 Z 10 of Regulation (EC) No. 765/2008 on the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 of the Council, OJ No. L 218 of August 13, 2008 p. 30;
16 "national accreditation body": a national accreditation body within the meaning of article 2 Z 11 of Regulation (EC) No. 765/2008;
17 "Conformity assessment": the procedures for the assessment, if the essential requirements of this regulation to an instrument have; been fulfilled
18 "Conformity assessment body": a body that performs conformity assessment activities including calibration, testing, certifications and inspections;
19 "Callback": any measure which one targets the end user of already provided meter on the achieving of the return;
20 'Withdrawal': any measure, that is, to prevent a supply chain as an instrument on the market, provide
21 ' harmonisation legislation of the Union ': legislation of the European Union on the harmonisation of the conditions for the marketing of products;
22 'CE marking': marking by which the manufacturer declares that the meter meets the requirements laid down in Community harmonisation of the European Union about its affixing.
Applicability of the provisions on part equipment
§ 4. Will apply in the calibration regulations of the Federal Office für Eich - und Vermessungswesen, hereafter referred to as "Verification requirements", sets the essential requirements for sub-assemblies, so the provisions of this regulation for these sub-assemblies according to. Sub-assemblies and measuring instruments can be evaluated independently and separately for purposes of determining compliance.
§ 5 (1) must satisfy the essential requirements referred to in annex 1, and the requirements of the corresponding calibration instructions a measuring instrument.
(2) the information provided for in annex 1 and in the calibration regulations are to deploy in the German language.
(3) the conformity of a measuring instrument with the essential requirements shall be evaluated in accordance with § 13.
6. (1) the manufacturer guarantee instruments that bring them into traffic or commissioned and should be used in accordance with the provisions of the MEG, in accordance with the essential requirements of annex 1 and the relevant calibration requirements have been designed and manufactured.
(2) the manufacturer create the technical documentation referred to in § 14 and perform the relevant conformity assessment procedure according to section 13, or perform it. Has been demonstrated with this conformity assessment procedures that a measuring instrument complies with the applicable requirements of this regulation and the calibration regulations, the manufacturer issuing an EU Declaration of conformity and affix the CE marking and supplementary metrology marking in accordance with article 16.
(3) the manufacturer store for 10 years the technical documentation and the EC declaration of conformity for the placing on the market of the instrument.
(4) the manufacturer through appropriate procedures ensure that compliance with this regulation is always ensured in repetitive manufacturing. Changes to the design of the meter or its characteristics and changes in the harmonised standards, normative documents or other technical specifications referred to in Declaration of conformity of a measuring instrument are thereby adequately taken into account.
(5) the manufacturer, if this is considered appropriate with regard to the performance of a meter, take samples of measuring instruments on the market, carry out audits and lead a register of complaints, of non-conforming meters the callbacks of measuring instruments, if necessary, and keep distributors informed of such monitoring.
(6) the manufacturer ensure that measuring equipment which they have placed on the market, a type, batch or serial number or a different flag contribute to their identification, or, if this is not possible due to the size or type of meter, that the required information in the the meter attached documents and, where appropriate, on the packaging in accordance with Annex 1 Z 9.2 are specified.
(7) manufacturers shall indicate their name, registered trade name or registered trade mark and the mailing address, which she achieved can be the gauge on the meter or if this is not possible, in the attached documentation and, where appropriate, on the packaging in accordance with Annex 1 Z 9.2. The address refers to a central point, at which the manufacturer can be achieved. The contact information is to specify in the German language.
(8) the manufacturer ensure that the measuring device marketed by them a copy of the EC declaration of conformity and the operating instructions in annex 1 Z 9.3 information attached are, which are written in the German language. These operating instructions and information, as well as all selections must be clear, understandable and clear.
(9) manufacturers who consider or have reason to believe that a meter installed by them in traffic corresponds to the requirements of this regulation or the calibration regulations, immediately take the corrective measures that are needed to establish the conformity of this instrument or to take it back, if necessary, or to call back. Also, inform the manufacturer the competent national authorities of the Member States of the European Union, in which they have provided the meter on the market, in, when are risks associated with the instrument, and do detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry for science to inform research and economy and the be are.
(10) the manufacturer make the Federal Minister for science, research and economy and the be substantiated request all information and documents which are required to demonstrate of the conformity of the measuring instrument with this regulation, in paper form or by electronic means in German language available. They cooperate with these authorities at their request with all measures to prevent risks associated with instruments, which they have placed on the market.
7. (1) a manufacturer may nominate in writing a representative. The obligations referred to in article 6, paragraph 1, and the obligation to prepare the technical documentation referred to in § 6 par. 2 are not part of the job of an agent.
(2) an authorised representative the tasks takes, which are set on behalf of the manufacturer. The contract must allow the agent to carry out at least the following tasks:
§ 8 (1) the importers have to bring only compliant measuring instruments on the market.
(2) before you install a gauge on the market or operate importers to ensure that the conformity assessment procedures concerned, referred to in article 13 was carried out by the manufacturer. Ensure that the manufacturer has created the technical documentation, that the meter with the CE marking and the supplementary metrology marking is provided, that the EU Declaration of conformity and the required documents are attached to him and that the manufacturer has satisfied the requirements of section 6, para 6 and 7.
(3) is an importer of considers or has reason to believe that a measuring device meets the essential requirements of annex 1 and the calibration regulations, he may bring this meter only in transport or operating them, if the conformity of the measuring instrument has been manufactured. If a risk is connected with the measuring device, the importers informed the manufacturer and the Federal Ministry for science, research and economy, as well as the be this.
(4) the importers give on the gauge their name, registered trade name or registered trade mark and the address at which they can be contacted, or if this is not possible, accompanying the measuring instrument in the documents and, where appropriate, on the packaging in accordance with Annex 1 Z 9.2. The contact details are in German language.
(5) ensure the importer, that the measuring device the operating instructions and in annex 1 Z 9.3 information in German language attached are.
(6) as long as a gauge is your responsibility, the importers ensure that the conditions of its storage or its transport 1 and the calibration regulations do not affect conformity with the essential requirements of annex.
(7) the importers take, if this is considered appropriate with regard to the performance of a meter, samples of measuring instruments on the market, carry out verifications and lead a register of complaints, of non-conforming meters the callbacks of measuring instruments, if necessary, and keep distributors informed of such monitoring.
(8) importers who consider or have reason to believe that a meter installed by them in traffic corresponds to the requirements of this regulation, immediately take the necessary corrective measures to establish the conformity of this monitor or, if necessary to take back or recall. Also inform the importer the competent national authorities of the Member States of the European Union, in which they have provided the meter on the market, in, if risks are associated with the device, and make this detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry for science to inform research and economy and the be are.
(9) the importers have ready after the placing on the market of the meter for ten years a copy of the EC declaration of conformity for the market surveillance authorities and ensure that they can present them to the technical documentation on request.
(10) the importers provide the Federal Ministry of science, research and economy and the be substantiated request all information and documents which are required to demonstrate of the conformity of the measuring instrument with this regulation, in paper form or by electronic means in German language available. They cooperate with these authorities at their request with all measures to prevent risks associated with instruments, which they have placed on the market.
Traders consider § 9 (1) the requirements of this regulation and the calibration regulations with due care when they provide a gauge on the market and/or into service.
(2) before they provide a gauge on the market or operate the dealer check whether the measuring instrument with the CE marking and the supplementary metrology marking is provided, whether it the EU Declaration of conformity, the required documentation and operating instructions and the 1 Z 9.3 other information mentioned in the German language are attached in annex, and whether the manufacturer and the importer have fulfilled the requirements of section 6, para 6 and 7 and § 8 para 4.
(3) a distributor of considers or has reason to believe that a gauge 1 and the corresponding calibration rules doesn't match with the essential requirements of annex, it only provides this meter on the market or it takes only into operation if its conformity has been established. If a risk is connected with the measuring device, the dealer also informed the manufacturer or the importer, as well as the Federal Ministry for science, research and economy, as well as the be about.
(4) as long as a measuring device is their responsibility, the dealer ensure that the conditions of its storage or its transport 1 and the calibration regulations do not affect conformity with the essential requirements of annex.
(5) distributors who consider or have reason to believe that a provided by them on the market or taken into service meter corresponds to not this regulation or the calibration regulations, make sure that the necessary corrective measures are taken to establish the conformity of this instrument, if necessary to take back or get back. In addition, inform the dealer the competent national authorities of the Member States of the European Union, where they have deployed the gauge on the market, about when risks are connected with the measuring device, and make this detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry for science to inform research and economy and the be are.
(6) the dealer provide all information and documents which are required to demonstrate of the conformity of a measuring instrument, in paper form or electronically available to the Federal Ministry of science, research and economy and the be substantiated request. They cooperate with these authorities at their request with all measures to prevent risks associated with products that have deployed to the market.
§ 10. An importer or Distributor is the manufacturer for the purposes of this regulation and subject to the obligations of a manufacturer according to § 6, when he under his own name or his own trade mark in trade presents a meter or a meter progress already on the market changed so that compliance with this regulation or the calibration regulations may be affected.
§ 11 (1) economic operators call the Federal Ministry for science, research and industry, as well as the be requested by economic operators.
(2) the economic operators may submit ten years from the cover of the meter, as well as ten years after the information output of the meter referred to in paragraph 1.
Section 12 (1) instruments that comply with harmonised standards or parts thereof, the reference numbers of which have been published, the conformity with the essential requirements referred to in annex assumed 1 and its verification provisions, which are covered by the relevant standards or parts thereof in the official journal of the European Union.
(2) gauges, matching parts of normative documents, whose Verzeichnis has been published in the official journal of the European Union the conformity with the essential requirements referred to in annex is suspected 1 and its verification provisions, which are covered by these parts of the normative documents.
(3) a manufacturer can opt for a technical solution that complies with the essential requirements referred to in annex 1 and the relevant calibration requirements. To take the presumption of conformity in the claim, it must apply also correctly solutions, after listed paragraphs 1 and 2 in the relevant harmonised standards or normative documents.
(4) Z 9 can be assumed compliance with the relevant test regulations according to § 14 para 3, if the corresponding test programme in accordance with the relevant documents mentioned in paragraphs 1 to 3 was carried out and the test results ensure compliance with the essential requirements.
13. (1) the evaluation of the conformity of a measuring instrument with the appropriate requirements according to § 5 according to a to be selected by the manufacturer conformity assessment procedure that is specified in the annex 2.
(2) a body notified under section 18 is active, then records and correspondence related to the carried out conformity assessment procedures either in German or in another by this point must recognized language to it.
Section 14 (1) the technical documentation must clearly make design, manufacture and operation of the measuring and allow the assessment of its conformity with the corresponding requirements of this regulation.
(2) the technical dossier must be detailed enough to meet the requirements of the following:
1. Description of metrological characteristics;
2. reproducibility of the metrological performances of produced instruments when they are properly set with adequate means provided for that purpose;
3. integrity of the instrument.
(3) as far as this is relevant to the assessment, as well as the identification of the type of device or meter, the technical documentation must contain in addition to the content referred to in paragraph 2:
1. a general description of the instrument;
2. designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
3. Description of the manufacturing process is used to ensure a uniform production;
4. where applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general information to the software explaining their characteristics and operation;
5. descriptions and explanations that are necessary for understanding the Z 2-Z 4, including the functioning of the meter;
6. a list of referred to in § 12, wholly or partly applied harmonised standards and/or normative documents, the reference numbers of which have been published in the official journal of the European Union;
7. a description of the solutions chosen for the fulfilment of the essential requirements of this Regulation as far as the harmonised standards referred to in article 12 or normative documents have not, been applied including a statement, which other relevant technical specifications have been applied;
8. the results of the design calculations, examinations, etc;
9 if necessary, appropriate test results with those of the proof that the type and/or instruments a) under the specified rated operating conditions and under specified environmental errors meet the requirements of this regulation;
(b) the specifications laid down in the calibration regulations for the resistance of gas, water and heat meters and measuring systems for liquids other than water are sufficient;
10 EU type examination or EU design examination certificates for measuring instruments, the parts contain, which are identical to those of the draft.
(4) the manufacturer shall specify where seals and markings are going to be.
(5) the manufacturer shall, where appropriate, to indicate the conditions for compatibility with interfaces and sub-assemblies.
Section 15 (1) the EU Declaration of conformity States that compliance with the essential requirements listed in annex 1 and the relevant calibration requirements has been detected.
(2) the EU Declaration of conformity corresponds to the model in annex 4 construction, contains the elements specified in the relevant modules of set out in annex 3, and is kept up to date. The manufacturer can assign a number on a voluntary basis of the Declaration of conformity. It is to write, if the meter in Austria in traffic is placed or made available in German language.
16. (1) the conformity of a measuring instrument with the provisions of this regulation is specified by the "CE" marking referred to in paragraph 2 and the supplementary metrology marking referred to in paragraph 3 on the gauge.
(4) the General principles referred to in article 30 of Regulation (EC) no 765/2008 according to apply for the supplementary metrology marking.
The CE marking and the supplementary metrology marking are § 17 (1) visibly, legibly and permanently to the instrument or to its data plate to install. If the kind of the measuring instrument does not allow this or does not justify they are attached on the accompanying document and, where appropriate, on the packaging.
(2) a measuring instrument consists of a set of cooperating devices of that are not equipment of part of be affixed the CE marking and the supplementary metrology marking on the main unit.
(3) the CE marking and the supplementary metrology marking is affixed prior to the placing on the market of the instrument.
(4) the CE marking and the supplementary metrology marking can be applied during the production process on the device, if this is justified.
(5) the supplementary metrology marking directly behind the CE marking. Behind the CE marking and the supplementary metrology marking is the identification number of the notified body, if this place in the production control in accordance with annex 3 worked.
(6) the identification number of the notified body shall be affixed by the body itself or according to its instructions, by the manufacturer or his authorised representative.
(7) the reference number of the competent notified body is durable or so to install it not not damaged can be removed.
(8) another character can stand behind the CE marking, the supplementary metrology marking and, where appropriate, the identification number of the notified body, indicating a special risk or use.
Section 18 (1) the notification of bodies is performed by the procedures referred to in §§ 18a-18 d MEG.
19. (1) a conformity assessment body has the requirements for the purposes of notification to meet paragraph 2 to 15.
1 not designer, manufacturer, supplier, Installer, purchaser, owner, user or maintenance operation of the instruments to be evaluated by them or representatives of one of these parties? This excludes using assessed already a conformity assessment instruments that are necessary for the activity of the conformity assessment body or the use of such instruments for personal use 2. not directly on the design, manufacture or construction, marketing, installation, use or maintenance of these instruments be involved, nor represent the parties involved in these activities. They may not deal with activities, which might impair their independence in assessing or their integrity relating to the conformity assessment activities for which they are notified. This applies particularly for consulting services.
However exclude the possibility of exchanges of technical information between the manufacturer and the conformity assessment body in any way.
(6) the conformity assessment bodies and their employees have to carry out the conformity assessment activities with the highest degree of professional and the necessary expertise in the relevant field; they should not be exposed any inducements, particularly financial, which could affect their judgement or the results of their conformity assessment activities, and specifically emanates from persons or groups of persons who have an interest in the outcome of these activities.
(7) a conformity assessment body must be able, all conformity assessment tasks to deal with, that fall to you pursuant to annex 3 and for which they shall notify regardless of whether these tasks are carried out by the body itself, on its behalf or under its responsibility.
2. descriptions of the procedures according to which conformity assessment is performed to ensure the transparency and the repeatability of these procedures. She has adequate tools and appropriate procedure distinguishes between the tasks which they perceived as notified body, and other activities, to have;
1. a sound technical and vocational training, which includes all activities for conformity assessment in the field, for which the conformity assessment body has been notified;
3. appropriate knowledge and understanding of the essential requirements of annex 1 and the relevant calibration requirements, of the applicable harmonised standards and normative documents and the relevant provisions of Community harmonisation of the European Union and national legislation;
(14) information, which receive the personnel of a conformity assessment body in carrying out its tasks in accordance with annex 3 under this regulation, be subject to the professional secrecy except to the competent authorities of the Member State of the European Union, in which they exercise their activities. Property rights are protected.
§ 20 a conformity assessment body demonstrates that it harmonised the criteria of the relevant standards or parts thereof complies, the reference numbers of which have been published in the official journal of the European Union, may be suspected that it meets the requirements according to § 19, insofar as the applicable harmonised standards cover those requirements.
§ 21 (1) awards the notified specific tasks connected with conformity assessment to subcontractors or transfers it this a branch company, so she has to ensure that the subcontractor or the subsidiary meets the requirements of article 19, and informed the notifying Authority accordingly.
(4) the notified bodies have to provide the relevant documentation concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work performed by him in accordance with annex 3 to the notifying authority.
Accredited internal bodies
§ 22 (1) can an accredited internal body for conformity assessment activities for the company, which she belongs to, for the purpose of implementing the annex 3 A2 and C2 module operate running procedure. This place has an own and separate part of the company to represent and shall not engage in design, production, delivery, installation, use or maintenance of measuring instruments evaluated by them.
(2) accredited internal bodies have meet the following criteria:
1. you are accredited, in accordance with Regulation (EC) No. 765/2008
2. the agencies and their employees are organizationally distinct from the company they belong to, and to have reporting procedures that ensure their impartiality, they demonstrate to the national accreditation body;
3. neither the authorities nor their employees are responsible for the design, manufacture, delivery, installation, operation or maintenance of the instruments to be evaluated by them or pursue an activity that could harm the independence of their judgment or their integrity in relation to their assessment activities;
4. the authorities provide their services exclusively for the company they are.
(3) accredited internal units are to inform the other Member States of the European Union or the European Commission does not, however, are to provide information on their accreditation by the company they belong to or by the national accreditation body of the notifying authority upon request.
Deployment on the market and putting into operation
section 23. The requirements of the commissioning (climatic conditions) are set in the calibration regulations as described below. The corresponding required upper and lower temperature limits must be selected from table 1 of annex 1, also humidity conditions (condensing or non-condensing), as well as the nature of the place of intended use may be prescribed (open or closed).
§ 24. Different accuracy classes for specific applications in the calibration regulations for meters are set, so the owner of the meter can use at any time a higher accuracy class for this application.
§ 25 meters, which are shown at trade fairs, exhibitions, demonstrations and the like, the provisions of this regulation then not comply, if clearly visible is that they do not meet the requirements and not get into traffic or in operation must be carried before the conformity with the provisions of this regulation has been established pointed out.
The notified bodies carry out conformity assessment in accordance with the conformity assessment procedure in accordance with Appendix 2 § 26 (1).
(2) conformity assessment be performed respecting of proportionality, avoiding unnecessary burdens for economic operators. The conformity assessment bodies perform their activities taking due account of the size of a company, the industry in which it operates, its structure, and the degree of complexity of the affected product technology and the Massenfertigungs - or serial nature of the production process. This, however, is a such level of protection to meet, as it is required for the conformity of the measuring instrument with this regulation.
(3) a notified body finds that a manufacturer does not met the essential requirements which are laid down in annex 1 and the relevant calibration regulations or corresponding harmonised standards and normative documents or other technical specifications, prompts them to the manufacturer to take appropriate corrective measures, and exhibits no certificate of conformity.
Section 27 (1) have reaching out the be the assumption that the aspects of protection of public interests, which fall under this regulation, endangered, judge a device covered by this regulation, whether the relevant instrument meets all the relevant requirements laid down in this regulation. The concerned economic operators have to cooperate with the be for this purpose to the extent necessary.
1. the measuring instrument does not meet the requirements laid down in this regulation with regard to the aspects of the protection of public interests, or 2 that a presumption of conformity applies harmonised standards or normative documents, compliance according to § 12, are flawed.
Risk due to compliant devices
Section 28 (1) is the Federal Ministry for science, research and industry or the relevant economic operator to the be is proof that a device poses a risk for aspects of the protection of public interests, although it complies with this regulation, to ask, to take all appropriate measures to ensure that the relevant instrument at its placing on the market no longer has this risk or that it is reasonable within one type of risk , taken reasonable period of time from the market or recalled.
(2) the economic operator to ensure that all corrective actions are taken, extend to all affected devices he has deployed in the European Union on the market.
Section 29 (1) without prejudice to section of the 27 is the relevant economic operator by the be to urge, to correct the non-compliance concerned if they notice one of the following cases:
1. the CE marking or the supplementary metrology marking has been in non-compliance with article 30 of Regulation (EC) No. 765/2008 or attached by section 17 of this regulation.
3. the identification number of the notified body - if this place in the production control phase worked - was placed under non-compliance of article 17 or has not been affixed;
4. the EC declaration of conformity has not been added to the meter;
5. the EC declaration of conformity has been improperly issued;
6. the technical documentation is either not available or not complete;
7. the information specified in § 6 section 7 or section 8 para 4 is missing, incorrect or incomplete;
8 another administrative request according to article 6 or article 8 is not met.
section 30. As far as this regulation to natural persons are related names only in the male form, they relate to women and men in the same way. In applying the term to certain natural persons, the respective gender-specific form is to use.
§ 31. Through this regulation, the policy will be 2014/32/EC on the harmonisation of legislation of Member States concerning the provision of measuring instruments on the market (recast), OJ No. L 96 of the 29.03.2014 p. 149, implemented.
Section 32 (1) from the 20th April 2016 only more instruments can in traffic for the first time be placed or started for the first time, which comply with this regulation.
(2) by way of derogation from paragraph 1 instruments can in traffic continues for the first time be placed or commissioned for the first time, II No. 274/2006, comply with the provisions of the meter regulation, federal law and have a still valid certificate for this.
(3) by way of derogation from paragraph 1 may meters, the II No. 274/2006 comply with the provisions of § 23 para 1 of meter regulation, Federal Law Gazette, only until 30 October 2016 are first placed on the market or are first put into operation.
33. (1) this regulation 20 April 2016 into force. At the same time the meter regulation, Federal Law Gazette II No. 274/2006 override.
(2) from the date of publication of this regulation according to § 18 can be designated.
(4) a placing on the market or a commissioning of instruments are marked under this regulation before the 20 April 2016 is not permitted.
A meter must ensure a high level of reliability, so that those affected can trust the results; Design and manufacturing must have a high level of quality in terms of metrology and the security of the data.
In the following, the requirements are listed to meet are the instruments. These are supplemented by device-specific requirements, which are included in the calibration regulations of the Bundesamt für Eich - und Vermessungswesen.
The solutions chosen because of the requirements take into account the intended use of the instrument and any foreseeable improper use.
The measurand is the size that is the subject of a measurement.
An influence quantity is a quantity that is not the measurand but influence the measurement result.
The rated operating conditions are the values for the measurand and influence quantities for the normal operation of a measuring instrument.
A disturbance is a factor, the value of which is within the limits prescribed by the appropriate requirement but outside the specified rated operating conditions of the measuring instrument. An influence quantity is a disturbance if for this factor, the rated operating conditions are not specified.
The limit is the value which is considered to be the change in the measurement result as not desirable.
A measuring scale is a device, which during its use one or more known values of a given size or shall be permanently reproduced provided.
A business process is known as direct sales, if
-the measurement as a basis for the price to be paid is at least at one of the parties that are affected by the operation associated with a measurement, a consumer or any other party, who needs a similar protection, and - all the parties affected by the operation acknowledge the measurement result on the spot.
Climatic environment conditions
The climatic conditions are the conditions under which measuring instruments may be used. Different temperature limits are designed to take account of climatic differences between the Member States of the European Union.
Companies that make sure the supply of electricity, gas, district heating and water are considered utilities.
1. error limits 1.1 under rated operating conditions and without the occurrence of a disturbance, the error of measurement must not exceed the extreme deviations approved in the corresponding calibration regulations (MPEs). Unless otherwise indicated in the calibration regulations, a margin of error as two-tailed value of the deviation from the true measurement value is expressed.
1.2. under rated operating conditions and in the event of a disturbance the performance requirement for the device of setting corresponds to in the appropriate standardisation regulations. Should the device be used in a given continuous electromagnetic field, the permitted measurement properties must be during the test in a modulated RF electromagnetic field within the error limits.
1.3 the manufacturer has the climatic, mechanical and electromagnetic environmental conditions under which the device is to be used, as well as the power supply and other factors that may affect its accuracy, to specify and taking into account the requirements laid down in the corresponding calibration regulations.
1.3.1 sets the upper and the lower limit of temperature climatic environment conditions of the manufacturer using the values shown in table 1, unless in the calibration regulations nothing is determined, and specifies what moisture conditions (condensing or non-condensing) and which location (open or closed) the device is designed.
1.3.2 a) the mechanical ambient conditions are divided as follows into classes M1 to M3:
This class applies to instruments used in locations where minor vibrations, and vibrations can occur, for example to light supporting structures attached measuring instruments, minor vibrations emitted by local explosive or pile driving, slamming doors, etc. and shocks are exposed.
This class applies to instruments used in locations where significant may occur to strong vibrations and shocks, caused E.g. from nearby machines and passing vehicles or from adjacent heavy machinery conveyor belts, etc.
This class applies to instruments used in locations where strong may occur to very strong vibrations and shocks, such as instruments that are mounted directly on machines, conveyor belts, etc.
(b) In relation to the mechanical environmental conditions the following factors are taken into account vibrations;-
1.3.3 a) the electromagnetic environment conditions are as follows divided into classes E1, E2, and E3, unless otherwise laid down in the calibration regulations.
This class applies to instruments used in locations with electromagnetic interference may occur such as in residential and commercial and light industrial buildings.
This class applies to instruments used in locations with electromagnetic disturbances may occur as in other industrial buildings.
This class applies to instruments with power supplied by the car battery. These instruments must comply with the requirements of the class E2 and the following additional requirements:
Voltage drop caused by the switching on of the starter motor circuits of internal combustion engines;
Transients in load waste that occurs when a discharged battery when the motor is disconnected.
(b) In relation to the electromagnetic environment conditions the following factors are taken into account voltage interruptions;-
-short-time voltage drops;
-Voltage transients on supply lines and/or signal lines,
-Electrostatic discharge;
-radio frequency electromagnetic fields;
-conducted radio frequency electromagnetic fields on supply lines and/or signal lines,
-Surges on supply lines and/or signal lines.
Influencing factors, where appropriate, to consider 1.3.4. other are:-voltage fluctuations;
-Fluctuations in the mains frequency;
-than magnetic fields;
-other sizes, which can have a significant influence on the accuracy of the meter.
1.4. following rules for carrying out the tests in accordance with this Regulation: 1.4.1. basic rules for testing and the determination of errors are the basic requirements of the Z 1.1 and 1.2 to check for each relevant influence quantity. Unless otherwise determined in the appropriate calibration instructions, these essential requirements apply when applying the factor and the determination of their effect for each individual factor separately, where all other factors are kept relatively constant at their reference value.
The metrological verification is run during or after applying the factor, where the State to take into account is that corresponds to the usual operation of the meter, in which the probability of occurrence of this factor is.
1.4.2. ambient humidity a) depending on the climatic environment of the meter should be used, either a damp heat constant temperature (non-condensing) test or a damp heat cyclic (condensing) test can be performed.
(b) the damp heat cyclic test is appropriate if the condensation of importance is or the penetration of steam is accelerated by the effect of breathing. Under conditions where it arrives to a condensation-free moisture content, checking the damp heat and constant temperature can be selected.
2. reproducibility must - evaluate the provision of identical measure at different locations and by different users under otherwise unmodified conditions - a close match of consecutive measurement results. Compared to the error limits, the individual results may differ only slightly from each other.
3. repeatability measuring an identical measure under identical test conditions must evaluate to a close match of consecutive measurement results. Compared to the error limits, the individual results may differ only slightly from each other.
4. threshold and sensitivity a meter must be sufficiently sensitive for each intended measurements and have a sufficiently low threshold.
5. resistance is an instrument to be interpreted, that its metrological characteristics over a period of time estimated by the manufacturer remain sufficiently stable, if properly set up and serviced, and used according to the instructions under the intended conditions.
6 reliability is an instrument to be interpreted, that the effect of a defect that would lead to an inaccurate measurement result, will as far as possible reduced provided that any such failure is not obvious.
7 fitness 7.1.
A meter must have no characteristics that facilitate a use fraudulently, and the possibility of accidental incorrect operation is to keep as low as possible.
7.2: a measuring device must be suitable taking account of the practical working conditions for the intended use and may make no unreasonably high demands to the user, to obtain a correct measurement result.
7.3. at flows or currents outside the permissible range, the error of a measuring instrument for utility services must have no excessive unilateral deviation.
7.4. a measuring instrument for the measurement of parameters is designed, which are constant over time, so the meter to small fluctuations in the measured quantity must be insensitive or respond appropriately.
7: 5 a measuring instrument must be robust, and the materials of which it consists, must be suitable for the intended conditions of use.
7.6: a measuring instrument is construed that the measuring operations can be controlled after the meter on the market was installed and put into operation. If necessary, the meter must have any special equipment or software for this control. The test procedure is to be described in the operating instructions.
If additional software has a gauge of, which performs other functions besides the measuring function, the software critical for the metrological characteristics shall be identifiable; It may be influenced by additional software not in an incorrect manner.
8. protection against distortion 8.1.
The metrological characteristics of a measuring instrument may are not affected by connecting another device, by the characteristics of the connected device or the characteristics of a separate device that conflicts with the measuring device in communication, in an incorrect manner.
8.2. a construction unit critical for the metrological characteristics is to be interpreted, that it can be secured. Backup measures must enable the detection of any intervention.
8.3. software that is critical for measurement characteristics is to label and secure. The identification of the software must be provided easily by the meter. Any intervention must be detectable over a reasonable period of time.
8.4. measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted, are adequate to protect against accidental or intentional corruption.
8.5. in case of displays of instruments for the measurement of services must allow the display of the total quantity or the displays from which the total quantity can be derived and which serve whole or in part as the basis for the settlement, do not reset during operation.
9 on the meter to be and to be in the gauge information 9.1.
On a measuring instrument, the following information are: a) manufacturer's name, registered trade name or registered trade mark b) information on accuracy, as well as, where appropriate, c) information on usage conditions d) measuring capacity e) measuring range f) identification marking g) number of EU type examination certificate or the EU design examination certificate h) information about whether additional facilities, which provide measurement results comply with the provisions of this regulation on the legal metrological control or not.
9.2. is a gauge too small or too sensitive, must to carry the necessary information, the packaging (if any) and the accompanying documents to be created under this regulation be marked accordingly.
9.3: details of its operation must be accompanied by the measuring instrument, provided that this is not avoided because of the simplicity of the measuring instrument. This information must be easy to understand and contain, where appropriate, the following information: a) rated operating conditions b) classes of mechanical and electromagnetic environments in c) upper and lower temperature limit, condensation is possible or not possible, open or closed location d) instructions for installation, maintenance, repairs and allowable settings e) instructions to ensure of a correct operation, as well as information on special conditions f) conditions for compatibility with interfaces , Sub-assemblies or measuring instruments.
9.4. groups of identical measuring instruments used in the same location, or for instruments for the measurement of utility services individual instructions are not strictly required.
9.5. unless otherwise determined in the calibration regulations is, the scale interval for a measured value 1 x 10n, 2 x 10n or 5 x 10n, where n is an integer or null. The unit of measurement or its symbol will be shown in the immediate vicinity of the numerical value.
9.6. a measuring scale is marked with a nominal value or a scale, and the used unit of measurement.
9.7. the units of measurement used and their symbols must correspond to the Community legislation on units of measurement and their symbols.
Must be clear, indelible, clearly and not transferable 9.8 after a request, all marks and inscriptions required.
Displaying the result of 10.1.
The result is displayed in the form of a Visual display or a hard copy.
10.2. the indication of the result must be clear and unambiguous, and provided with the required marks and inscriptions, to emphasize the importance of the result the user. Under normal conditions, an easy reading of the presented result must be ensured. Additional ads are permitted where confusion with the subject of the metrological control ads are excluded.
10.3. be printed or recorded, the results must be clearly legible and indelible manner, the term and the recording.
10.4. a measuring device that is used for the processing of direct sales, is construed as meaning that the measurement result for proper installation of the gauge shows both parties. As far as this is in the case of direct sales of vital importance, receipt slip issued by peripheral devices which do not meet the relevant requirements of this regulation, for the customer, must wear a restrictive notice.
10.5. measuring instruments for the measurement of utility services are regardless of whether they remotely be can metrologically definitely to equip with a metrological-controlled level indicator, which is accessible to the consumer without any AIDS. The reading of this display is measuring result, which constitutes the basis for the price to be paid.
11 further processing of data to conclude of the trading transaction 11.1.
A gauge that is used not the measurement of utility services, must record permanently the measurement result and the information required for the determination of a particular business operation, if the measurement is not repeatable and is the measuring instrument is normally intended to be used in the absence of one of the parties.
11.2. Moreover, a durable proof of the measurement result and the information required for the determination of a particular business operation available must be when the measurement is completed upon request.
12 Declaration of conformity is a measuring instrument must be interpreted, that it is possible to easily assess of its conformity with the corresponding requirements of this regulation.
Legal conformity assessment procedures
1 water meters intended for the measurement of volume of clean cold or hot water: B + F or B + D or H1.
2. gas meters and volume corrector: B + F or B + D or H1;
3. active electrical energy meters intended for use in the household, in the commercial and light industrial: B + F or B + D or H1.
4. heat meters: B + F or B + D or H1;
5. measuring systems for the continuous and dynamic measurement of quantities of liquids other than water: B + F or B + D or H1 or g.;
6 automatic weighing instruments: a) for mechanical measuring instruments: B + D, or B + E or B + F or D1 or F1 or G or H1.
(b) for electromechanical instruments: B + D B + E or B + F or G or H1;
(c) for measuring instruments containing electronic measuring equipment or software: B + D, or B + F or G or H1;
7 meter: B + F or B + D or H1;
8 level impersonations: a) embodied length: F1 or D1 or B + D or H or G;
(b) serving: A2 or F1 or D1 or E1 or B + E or B + D or H;
9 meters for the measurement of length and their combinations: a) 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.;
(b) B + F for for electronic instruments or instruments, the software included: Or B + D or H1 or G.
1. internal production control is the conformity assessment procedure, with which the manufacturer complies with the obligations referred to in the Nos. 2, 3 and 4 and ensures and declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of this regulation.
2. technical documentation of the manufacturer creates the technical documentation described in section 14. On the basis of these documents, it must be possible to evaluate the conformity of the measuring instrument with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the requirements list and the design, the manufacture and operation of the product are to capture, as far as they are for the assessment of relevance.
3. making the manufacturer take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the instruments with the technical documentation referred to in subpara 2 and with the requirements of this regulation.
4. conformity marking and EC declaration of conformity 4.1.
The manufacturer must affix the CE marking and the supplementary metrology marking to each individual instrument, which complies with the applicable requirements of this regulation, pursuant to this regulation.
4.2: the manufacturer issues a written EC declaration of conformity for a gauge model and holds it together with the technical documentation for the placing on the market of the instrument for ten years for the national authorities. Must be drawn from the EU Declaration of conformity for which instrument was issued.
A copy of the EC declaration of conformity shall be annexed each measuring instrument that is placed on the market. In cases where a large number supplied by instruments at one and the same user, be interpreted this requirement in a way that it does not apply to individual devices, but for a lot or a broadcast.
5. authorised representative, the obligations of the manufacturer referred to in no. 4 can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order.
Module A2: Internal production control plus supervised device checks at irregular intervals
1. the internal control of production with monitored device testing occurring at irregular intervals is the conformity assessment procedure, with which the manufacturer complies with the obligations referred to in the Nos. 2, 3, 4 and 5 and guarantees and on own responsibility declares that the measuring instruments concerned satisfy the requirements of this regulation.
2. technical documentation of the manufacturer creates the technical documentation described in section 14. On the basis of these documents, it must be possible to evaluate the conformity of the equipment with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the requirements list and the design, the manufacture and operation of the product are to capture, as far as they are for the assessment of relevance.
3. making the manufacturer take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured equipment with the technical documentation referred to in subpara 2 and with the requirements of this regulation.
4. unit tests depending on the decision of the manufacturer conducts an accredited internal body or a notified body chosen by him at irregular intervals established unit testing or can perform to check the quality of the internal checks of the device, taking account inter alia the technical complexity of the equipment and the amount of production. Prior to the placing on the market takes place on the spot a suitable sample of the final meters and investigated them; In addition, she performs appropriate tests according to the relevant sections of the harmonized norm and/or normative document or equivalent tests of in accordance with other relevant technical specifications, to check the conformity of the equipment with the relevant requirements of this regulation. In the absence of a harmonised standard or a relevant normative document, the accredited internal authority or the notified body decides what checks are performed.
A significant number of devices as the sample taken is not an acceptable quality level, so the accredited internal authority or the notified body shall take the necessary measures.
A notified body performs the checks to the manufacturer under the responsibility of the notified body brings their identification number during the manufacturing process.
5. conformity marking and EC declaration of conformity 5.1.
On each unit, that satisfies the applicable requirements of this regulation, the manufacturer shall affix the CE marking and supplementary metrology marking in accordance with this regulation.
5.2: the manufacturer issues a written EC declaration of conformity for a machine model and holds them together with the technical documentation for the placing on the market of the device for ten years for national authorities. Must be drawn from the EU Declaration of conformity for which device was issued.
A copy of the EC declaration of conformity shall be annexed each measuring instrument that is placed on the market. In cases where a large number supplied by devices on one and the same user, be interpreted this requirement in a way that it does not apply to individual devices, but for a lot or a broadcast.
6. authorised representative, the obligations of the manufacturer referred to in Z 5 can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order.
1. in the "EU type examination" is the part of a conformity assessment procedure in which a notified body examines the technical design of a measuring instrument and checks and certifies that it meets the requirements applicable to the device in this regulation.
2. a EU prototype testing can be performed on each of the following types: a) examination of a representative of the production envisaged pattern of the complete measuring device (type);
b) assessment of the suitability of the technical design of the measuring instrument on the basis of an examination of the technical documentation referred to in no. 3 and supporting evidence, as well as examination of specimens, representative of the production envisaged one or more important parts of the device (combination of construction and design patterns);
c) assessment of the adequacy of the technical design of the unit on the basis of an examination of the technical documentation referred to in no. 3 and supporting evidence, without testing a pattern (design pattern).
The notified body decides on the appropriate form and the required pattern.
3. the request for EU type examination is from the manufacturer with a single notified body of his choice to submit.
The application contains the following: a) name and address of the manufacturer and, if the application is lodged by the authorised representative, also its name and address;
(c) the technical documentation described in section 14. On the basis of the technical documentation, it must be possible to evaluate the compliance of the product with the applicable requirements of this regulation; they must contain a proper risk analysis and evaluation. In the technical documentation, the requirements list and the design, the manufacture and operation of the product are to capture, as far as they are for the assessment of relevance.
The application includes, where appropriate, at least the following elements: d) of the representative samples of production. The notified body may request additional patterns, if this is necessary for the implementation of the auditor;
(e) the supporting evidence for a reasonable solution through the technical design. In this additional evidence, all documents must be noted according to which especially is been taken, if the relevant harmonised standards and/or normative documents not in its entirety have been applied. The additional evidence, if necessary, include the results of tests conducted in accordance with other relevant technical specifications by an appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
4. the notified body shall have the following duties: based on the unit: 4.1. examination of the technical documentation and supporting evidence to assess whether the technical design of the device is appropriate;
Based on the pattern: 4.2. check, whether that and the pattern in accordance with the technical documentation was established / n, and finding, which parts have been designed according to the applicable provisions of the relevant harmonised standards and/or normative documents and what parts in accordance with other relevant technical specifications designed;
4.3. perform or request the appropriate examinations and tests, to determine whether the solutions in the relevant harmonised standards and/or normative documents correctly, been applied unless the manufacturer has opted for their application;
4.4. implementing or arranging the appropriate examinations and tests, meet to determine whether the solutions chosen by the manufacturer, and the corresponding essential requirements of this regulation if he has not applied to the solutions in the relevant harmonised standards and/or other normative documents, on the basis of other relevant technical specifications have been achieved;
4.5. agreement with the manufacturer, where the examinations and tests to be performed.
Relative to the other parts of the measuring instrument: 4.6. examination of the technical documentation and supporting evidence to assess whether the technical design of the other parts of the measuring instrument is appropriate.
5. the notified body creates an audit report on the measures carried out in accordance with no. 4 and the results obtained. Without prejudice to their obligations under the notifying authorities, the notified body shall published the content of this report, or parts of them only with the consent of the manufacturer.
6 the sample corresponds to the question gauge requirements of this regulation, the notified body issues an EU type examination certificate the manufacturer. The certificate must contain the name and address of the manufacturer, the results of the audit, any conditions for its validity and the particulars necessary for identification of the approved of type. One or more attachments can be added to the EU type examination certificate.
The EU type examination certificate and its annexes contain all relevant information, according to which the conformity of the manufactured instruments assess approved type and, if necessary, a control is after her commissioning. The conformity of the manufactured instruments, when they are properly adjusted with adequate means provided for that purpose, in terms of repeatability of their metrological performances, to be able to assess with the tested models in particular is to specify:-the metrological characteristics of the type of the device.
-that to ensure the integrity of the device (sealing, identification of software, etc.) necessary measures;
-other information which are necessary to identify the device and to the Visual inspection as regards its external conformity to type;
-where appropriate, specific disclosures, which are required for the verification of the characteristics of manufactured instruments;
-in the case of a device of of part of all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments.
The EU type examination certificate is valid for ten years from their date of issue and may be renewed thereafter for another ten years.
7. the notified body shall inform continuously about all changes in the generally acknowledged State of the art; These indicate that the approved type no longer complies with the applicable requirements of this regulation, it decides whether such changes require further investigations. This is the case, so the notified body shall inform the manufacturer accordingly.
8. the manufacturer shall inform the notified body of the dossiers to the EU type examination certificate are available, all modifications to the approved design which affect whose conformity with the essential requirements of this regulation or the conditions for the validity of this certificate can. Such modifications require additional approval in the form of an addition to the original EU-type test certificate.
9. each notified body shall inform their notifying authority of the EU type examination certificates and/or any additions, which has issued them, or withdrawn, and submitted a list of all such certificates and/or additions to, who has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.
If you require this, the European Commission, the Member States of the European Union and the other notified bodies will receive a copy of the EU type examination certificates and/or their additions. The European Commission and the Member States of the European Union will receive a copy of the technical documentation and the results of the checks made by the notified body on request.
The notified body shall so long kept a copy of the EU test certificate together with the annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the period of validity of this certificate.
10. the manufacturer holds for ten years a copy of the EU test certificate together with the annexes and additions together with the technical documentation for the placing on the market of the device for the national authorities.
The authorised representative of the manufacturer can submit the application referred to in no. 3 and meet the obligations referred to in the Nos. 8 and 10, if they are set in the order.
1. the conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer in the Z meets the 2 and 3 these obligations and guarantees and declares that correspond to the relevant instruments of the type described in the EU type examination certificate and comply with the applicable requirements of this regulation.
2. making the manufacturer take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the approved type as described in the EU type examination certificate and with the requirements of this regulation.
3. conformity marking and EC declaration of conformity 3.1.
On each unit, that coincides with the type as described in the EU type examination certificate and satisfies the relevant requirements of this regulation, the manufacturer shall affix the CE marking and the supplementary metrology marking required under this regulation.
3.2 the manufacturer issues a written EC declaration of conformity for each model of appliance and holds them after the placing on the market of the device for ten years for the national authorities. Must be drawn from the EU Declaration of conformity was issued which device model.
4. authorised representative, the obligations of the manufacturer referred to in no. 3 can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order.
Module C2: Conformity to type based on internal production control with monitored device tests at regular intervals
1. the conformity to type on the basis of an internal production control plus supervised product checks at irregular intervals is the part of a conformity assessment procedure, in which the manufacturer complies with the obligations referred to in the Nos. 2, 3 and 4 and guarantees and on their own responsibility declares that the measuring instruments concerned of the type described in the EU type examination certificate comply with and meet the requirements of this regulation.
2. making the manufacturer take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the type as described in the EU type examination certificate and with the applicable requirements of this regulation.
3. unit testing depending on the decision of the manufacturer conducts an accredited internal body or a notified body chosen by him at irregular intervals established unit testing or can perform to check the quality of the internal checks of the device, taking account inter alia the technical complexity of the instruments and the quantity of production. Takes an appropriate sampling of instrument intended for the end user the accredited internal authority or the notified body on the ground prior to the placing on the market and examined them; In addition, she performs appropriate tests according to the relevant sections of the harmonised standards and/or other normative documents or equivalent tests in accordance with other relevant technical specifications, to check the conformity of the equipment with the type as described in the EU Baumusterprüfbescheinigung and with the corresponding requirements of this regulation.
The test is not an acceptable quality level, so the accredited internal authority or the notified body shall take the necessary measures.
This sampling will determine whether the manufacturing process of the device within acceptable limits moves to ensure the conformity of the device.
To each individual instrument that corresponds with the type as described in the EU type examination certificate and satisfies the applicable requirements of this regulation, the manufacturer shall affix the CE marking and the supplementary metrology marking.
4.2: the manufacturer issues a written EC declaration of conformity for each model of appliance and holds them after the placing on the market of the device for ten years for the national authorities. Must be drawn from the EU Declaration of conformity was issued which device model.
Module D: conformity to type on the basis of a quality assurance related to the production process
1. the conformity to type on the basis of a quality assurance based on the production process is the part of a conformity assessment procedure, in which the manufacturer met in the Z 2 and 5 laid down obligations and to ensure and on their own responsibility declares that the measuring instruments concerned of the type described in the EU type examination certificate comply with and meet the requirements of this regulation.
2. making the manufacturer operates a quality system for production, final inspection and testing of the measuring instruments concerned in accordance with no. 3 and is subject to the surveillance referred to in no. 4.
3. quality system 3.1.
The assessment of his quality assurance system for the measuring instruments concerned the manufacturer must apply to a notified body of his choice.
(e) the technical documentation of the approved type and a copy the EU type examination certificate.
3.2. the quality assurance system ensures conformity of the instruments with the type as described in the EU type examination certificate and with the applicable requirements of this regulation.
(d) the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned;
(e) funds will be used to monitor the achievement of the required product quality and the effective operation of the quality assurance system.
3.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in 3.2 Z.
In each part of the quality assurance system, which complies with the corresponding specifications of the relevant harmonised standard, it comes from a conformity with these requirements.
In addition to experience in quality management systems, at least one member of the audit has experience with the evaluation in the relevant area of the device and the device technology concerned, and knowledge of the applicable requirements of this regulation. The audit includes also an inspection visit at the premises of the manufacturer.
The audit team reviewed the in Z 3.1 lit. referred e technical documentation, to ensure that the manufacturer able is to identify the relevant requirements of this regulation and making the necessary verifications, to ensure conformity of the product with these requirements.
The decision is notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned of assessment decision.
3.4. the manufacturer is committed to meet the obligations associated with the approved quality assurance system and ensuring that it is held always correctly and efficiently.
3.5. the manufacturer shall inform the notified body that has approved the quality system of any planned changes of the quality assurance system.
The notified body shall evaluate any proposed changes and decide whether the modified quality assurance system complies with still referred to in Z 3.2 or whether a re-assessment is required.
It announces its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned of assessment decision.
4. surveillance under the responsibility of the notified body 4.1.
4.2. the manufacturer grants access to the manufacturing, inspection, testing and storage of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;
(b) the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned.
4.3. the notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes him a corresponding report.
4.4. Additionally, the notified body the manufacturer may carry out unannounced visits. During these visits, the notified body may, if necessary, perform unit tests or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.
The manufacturer must affix the CE marking, the supplementary metrology marking in accordance with this regulation and under the responsibility of the notified body referred to in 3.1 Z whose identification number to each individual instrument that corresponds with the type as described in the EU type examination certificate and satisfies the applicable requirements of this regulation.
5.2: the manufacturer issues a written EC declaration of conformity for each model of appliance and holds them after the placing on the market of the device for ten years for the national authorities. Must be drawn from the EU Declaration of conformity was issued which device model.
6 the manufacturer for a period of ten years from the placing on the market of the equipment for the national authorities, following documents provides: a) the documentation referred to in 3.1; Z
(b) the information on the amendment in accordance with Z 3.5 in its approved form;
(c) the decisions and reports of the notified body according to the Z 3.5, 4.3 and 4.4.
7. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.
8. authorised representative can 3.1, 3.5, 5 and 6 referred to obligations of the manufacturer in Z of his authorised representative, on his behalf and be fulfilled under his responsibility, if they are set in the order.
Module D1: quality assurance related to the production process
1. when the quality assurance related to the production process is the conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the Nos. 2, 4 and 7 and ensures and on their own responsibility declares that the measuring instruments concerned satisfy the requirements of this regulation.
2. technical documentation of the manufacturer creates the technical documentation described in section 14. On the basis of these documents, it must be possible to evaluate the conformity of the equipment with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the requirements list and the design, the manufacture and operation of this device are to capture, as far as they are for the assessment of relevance.
3. the manufacturer holds for ten years the technical documentation for the placing on the market of the device for national authorities.
4. making the manufacturer operates a certified quality assurance system for production, final product inspection and testing of measuring instruments concerned according to Z 5 and is subject to monitoring in accordance with no. 6.
5. quality assurance system 5.1.
(e) the technical documentation referred to in no. 2.
5.2. the quality assurance system ensures conformity of the instruments with the requirements of this regulation.
(d) quality-related records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned;
5.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in Z 5.2.
In addition to the experience with quality assurance systems, at least one member of the audit has experience with the evaluation in the relevant area of the device and the device technology concerned, and knowledge of the applicable requirements of this regulation. The audit includes also an inspection visit at the premises of the manufacturer.
The audit team reviewed the technical documentation referred to in no. 2, to ascertain that the manufacturer able is to identify the relevant requirements of regulation and making the necessary verifications, to ensure conformity of the product with these requirements.
5.4. the manufacturer is committed to meet the obligations associated with the approved quality assurance system and ensuring that it is held always correctly and efficiently.
The manufacturer shall keep the notified body that has approved the quality system of any planned changes of the quality assurance system.
The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system complies with still referred to in Z 5.2 or whether a re-assessment is required.
6. monitoring under the responsibility of the notified body 6.1.
6.2. the manufacturer grants access to the manufacturing, inspection, testing and storage of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;
(b) the technical documentation referred to in item 2;
(c) the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned.
6.3. the notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes him a corresponding report.
6.4. Additionally, can the notified body the manufacturer unannounced visits. During these visits, the notified body may, if necessary, perform unit tests or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.
7 conformity marking and EC declaration of conformity 7.1.
The manufacturer must affix the CE marking, the supplementary metrology marking in accordance with this Regulation as well as under the responsibility of the notified body referred to in 5.1 Z whose identification number to each individual instrument that meets the applicable requirements of this regulation.
7.2: the manufacturer issues a written EC declaration of conformity for each model of appliance and holds them after the placing on the market of the device for ten years for the national authorities. Must be drawn from the EU Declaration of conformity was issued which device model.
8 the manufacturer for a period of ten years from the placing on the market of the equipment for the national authorities, following documents provides: a) the documentation referred to in Z 5.1;
(b) the information on the amendment in accordance with Z 5.5 in its approved form;
(c) the decisions and reports of the notified body according to the Z 5.5, 6.3 and 6.4.
9. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.
10. authorised representative can 3, 5.1, 5.5, 7, and 8 referred to obligations of the manufacturer in Z of his authorised representative, on his behalf and be fulfilled under his responsibility, if they are set in the order.
Module E: conformity to type based on quality assurance related to the device
1. conformity to type on the basis of a quality assurance based on the device is the part of a conformity assessment procedure, in which the manufacturer met in the Z 2 and 5 laid down obligations and to ensure and on their own responsibility declares that the measuring instruments concerned of the type described in the EU type examination certificate comply with and meet the requirements of this regulation.
2. making the manufacturer operates a certified quality assurance system for final inspection and testing of measuring instruments concerned in accordance with no. 3 and is subject to monitoring in accordance with no. 4.
3.2. the quality assurance system ensures conformity of the instruments with the type described in the EU type examination certificate and the requirements of this regulation.
b) investigations carried out after manufacturing and testing;
(c) quality-related records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned;
(d) funds will be used to monitor the effective operation of the quality assurance system.
The decision is notified to the manufacturer. The communication includes the conclusion of the audit and the reasoned of assessment decision.
The notified body shall assess all proposed changes and decide whether the modified quality assurance system complies with still referred to Z 3.2 or whether a re-assessment is required.
In addition, the notified body the manufacturer can perform unannounced visits. During these visits, the notified body may, if necessary, perform unit tests or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.
The manufacturer shall affix its identification number on each unit, that coincides with the type as described in the EU type examination certificate and satisfies the applicable requirements of this regulation, the CE marking, the supplementary metrology marking prescribed under this regulation and under the responsibility of the notified body referred to in 3.1 Z.
Module E1: quality assurance of final product inspection and testing of devices
1. quality assurance of final product inspection and testing of the devices is the conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the Nos. 2, 4 and 7 and ensures and on their own responsibility declares that the measuring instruments concerned satisfy the requirements of this regulation.
3. the manufacturer must have for ten years the technical documentation for the placing on the market of the device for the competent national authorities.
4. making the manufacturer maintains an approved quality system for final product inspection and testing of measuring instruments concerned pursuant to sub-para. 5 and is subject to monitoring in accordance with no. 6.
(c) the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned;
The audit team reviewed the technical documentation referred to in no. 2, to ascertain that the manufacturer able is to identify the relevant requirements of regulation and making the necessary verifications, to ensure conformity of the product with these requirements. The decision is notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned of assessment decision.
5.5. the manufacturer shall inform the notified body that has approved the quality system of any planned changes of the quality assurance system.
The notified body shall evaluate all proposed changes and decide whether the modified quality assurance system complies with still referred to Z 5.2 or whether a re-assessment is required. It announces its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned of assessment decision.
The manufacturer must affix the CE marking, the supplementary metrology marking in accordance with this Regulation as well as under the responsibility of the notified body referred to in 5.1 Z whose identification number on each individual instrument that satisfies the appropriate requirements of this regulation.
A copy of the EC declaration of conformity is provided the competent authorities upon request. A copy of the EC declaration of conformity shall be annexed each measuring instrument that is placed on the market. In cases where a large number supplied by devices on one and the same user, be interpreted this requirement in a way that it does not apply to individual devices, but for a lot or a broadcast.
8 the manufacturer for a period of ten years from the placing on the market of the equipment for the national authorities, following documents provides: a) the documentation referred to in 5.1, Z b) the information on the amendment in accordance with Z 5.5 in its approved form;
Module F: conformity to type based on a product audit
1. the conformity to type on the basis of product verification is the part of a conformity assessment procedure whereby the manufacturer who in the Z fulfils 2, 5.1 and 6 fixed obligations and guarantees and on their own responsibility declares that comply with the provisions of Z 3 submissive affected measuring devices of the type described in the EU type examination certificate and comply with the applicable requirements of this regulation.
3. verification a notified body chosen by the manufacturer carries out the appropriate examinations and necessary tests or can perform to check the conformity of the equipment with the type as described in the EU Baumusterprüfbescheinigung and the applicable requirements of this regulation. The examinations and tests to check of the conformity of the instruments with the requirements are performed either by examination and testing of each individual device in accordance with no. 4 or by means of a statistical examination and testing of measuring instruments in accordance with Z 5 at the choice of the manufacturer.
4. verification of conformity by examination and testing of each individual device 4.1.
All instruments are individually examined and appropriate tests according to the be performed relevant harmonised standard (s) and/or the normative documents or equivalent tests of in accordance with other relevant technical specifications, to verify their conformity with the approved type described in the EU type examination certificate and the applicable requirements of this regulation. In the absence of a harmonised standard or a normative document, the notified body decides what checks are performed.
4.2. the notified body shall issue a conformity certificate on the basis of these examinations and tests and brings their identification number to each approved instrument or can bring them under their responsibility. The manufacturer shall provide for ten years the certificates of conformity after the placing on the market of the device for the national authorities for inspection.
5. verification of conformity with statistical means 5.1.
The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure the uniformity of all produced lots and shall present his instruments in single batches for verification.
5.2. an any sample is taken in accordance with 5.3 Z each batch. Each instrument from a sample is individually to investigate, and there are corresponding tests in accordance with the relevant harmonised standard/s, and/or the / which carry normative document/documents or equivalent tests of in accordance with other relevant technical specifications to ensure its conformity with the type as described in the EU type examination certificate and with the applicable requirements of this regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, or of such a normative document, the notified body shall decide what checks are performed.
5.3. the statistical procedure are to consider the following: the statistical control is carried out on the basis of features. The sampling plan must ensure the following: a) a level of quality corresponding to a probability of acceptance of 95%, and a non-conformity of less than 1%;
(b) a limit quality corresponding to a probability of acceptance of 5% and a non-conformity of less than 7%.
5.4. assumes a lot so all instruments of the lot are approved, eminent except sampled instruments to satisfy.
The notified body shall issue a conformity certificate on the basis of these examinations and tests and brings their identification number to each approved instrument or can bring them under their responsibility. The manufacturer provides for ten years the certificates of conformity after the placing on the market of the equipment for the national authorities.
5.5. If a lot is rejected, so the notified body shall take appropriate measures to prevent bringing the lot in traffic. In the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.
6 conformity marking and EC declaration of conformity 6.1.
The manufacturer shall affix its identification number to every single device that complies with the approved type as described in the EU type examination certificate and meets the applicable requirements of this regulation, the CE marking and the supplementary metrology marking prescribed by this regulation and, under the responsibility of the notified body referred to in no. 3 -.
6.2 the manufacturer issues a written EC declaration of conformity for each model of appliance and holds them after the placing on the market of the device for ten years for the national authorities. Must be drawn from the EU Declaration of conformity was issued which device model.
A copy of the EC declaration of conformity is provided the competent authorities upon request. A copy of the EC declaration of conformity shall be annexed each measuring instrument that is placed on the market. In cases where a large number supplied by devices on one and the same user, be interpreted this requirement in a way that it does not apply to individual devices, but for a lot or a broadcast. Agrees with the notified body referred to in no. 3 of the manufacturer under the responsibility of the notified body can now attach the identification number of the notified body products.
7. agrees to the notified body, the manufacturer under the responsibility of the notified body can now attach the identification number of the notified body during the manufacturing process on the products.
8. authorised representative, the obligations of the manufacturer can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order. An agent cannot fulfill the obligations laid down in the Nos. 2 and 5.1 of the manufacturer.
MODULE F1: Compliance on the basis of an examination of the products
1. compliance on the basis of product verification is the part of a conformity assessment procedure whereby the manufacturer who in the Z meets 2, 3, 6.1 and 7 laid down obligations and ensures and declares on its own responsibility, that the the provisions of Z 4 submissive affected instruments meet the requirements of this regulation.
The manufacturer must have for ten years the technical documentation for the placing on the market of the device for the competent national authorities.
3. making the manufacturer take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the applicable requirements of this regulation.
A notified body chosen by the manufacturer carries out the appropriate examinations and tests, or may be performed to check the conformity of the instruments with the applicable requirements of this regulation. The examinations and tests to check of the conformity with the requirements are performed either by examination and testing of each individual device according to Z 5 or by means of a statistical examination and testing of measuring instruments in accordance with no. 6 at the choice of the manufacturer.
5. verification of conformity by examination and testing of each individual device 5.1.
All instruments are individually to investigate and there are other relevant technical specifications corresponding tests in accordance with the relevant harmonised standards and/or other normative documents, and/or equivalent tests according to carry out to ensure their conformity with the for them to requirements. In the absence of such a harmonised standard, or of such a normative document, the notified body shall decide what checks are performed.
5.2. the notified body shall issue a conformity certificate on the basis of these examinations and tests and brings their identification number to each approved instrument or can bring them under their responsibility. The manufacturer provides for ten years the certificates of conformity after the placing on the market of the equipment for the national authorities.
6. checking of the compliance with statistical means 6.1.
The manufacturer must take all measures necessary so that the manufacturing process ensures the uniformity of all produced lots and shall present his instruments in single batches for verification.
6.2. an any sample is taken according to Z 6.4 each batch.
6.3. is each instrument from a sample to examine separately and carry out corresponding tests in accordance with the relevant harmonised standards and/or normative documents or equivalent tests in accordance with other relevant technical specifications, to ensure its conformity with the applicable requirements of this regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, or of such a normative document, the notified body shall decide what checks are performed.
6.4. the statistical procedure are to consider the following: the statistical control is carried out on the basis of features. The sampling plan must ensure the following: a) a level of quality corresponding to a probability of acceptance of 95%, and a non-conformity of less than 1%;
6.5. assumes a lot so all instruments of the lot are approved, eminent except sampled instruments to satisfy.
The notified body shall issue a conformity certificate on the basis of these examinations and tests and brings their identification number to each approved instrument or can bring them under their responsibility.
The manufacturer provides for ten years the certificates of conformity after the placing on the market of the equipment for the national authorities.
If a lot is rejected, the notified body shall take appropriate measures, to prevent bringing the lot in traffic. In the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.
The manufacturer must affix the CE marking and the whose identification number to each individual instrument that meets the applicable requirements of this regulation, according to this regulation the prescribed supplementary metrology marking and, under the responsibility of the notified body referred to in no. 4.
A copy of the EC declaration of conformity shall be annexed each measuring instrument that is placed on the market. In cases where a large number supplied by devices on one and the same user, be interpreted this requirement in a way that it does not apply for individual instruments, but for a lot or a broadcast.
Agrees with the notified body referred to in Z 5 the manufacturer under the responsibility of the notified body can now attach the identification number of the notified body to the products.
8. agrees with the notified body, the manufacturer under the responsibility of the notified body can now attach the identification number of the notified body during the manufacturing process on the devices.
9. authorised representative, the obligations of the manufacturer can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order. An authorised representative must meet not the manufacturer's obligations set out in subpara 2 first paragraph, Z 3 and Z 6.1.
Module g conformity based on a single audit
1. for compliance on the basis of a single test is the conformity assessment procedure, with which the manufacturer complies with the obligations referred to in the Nos. 2, 3 and 5 and ensures and declares on its own responsibility, that the the provisions of no. 4 subjected gauge the gauge this regulation requirements applicable.
2. technical documentation of the manufacturer creates the technical documentation described in § 14 and puts them at the disposal of the notified body referred to in no. 4. On the basis of these documents, it must be possible to evaluate the conformity of the equipment with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the requirements list and the design, the manufacture and operation of this device are to capture, as far as they are for the assessment of relevance. The manufacturer holds for ten years the technical documentation for the placing on the market of the device for the competent national authorities.
3. manufacture the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured equipment with the applicable requirements of this regulation.
4. verification a notified body chosen by the manufacturer carries out the appropriate examinations and tests in accordance with the relevant harmonised standards and/or normative documents or equivalent tests of in accordance with other relevant technical specifications or can perform to check the conformity of the product with the applicable requirements of this regulation. In the absence of such a harmonised standard, or of such a normative document, the notified body shall decide what checks are performed.
The manufacturer shall affix its identification number to any instrument that complies with the applicable requirements of this regulation, the CE marking and the supplementary metrology marking prescribed under the Ordinance and under the responsibility of the notified body referred to in no. 4.
5.2: the manufacturer issues a written EC declaration of conformity and holds them after the placing on the market of the device for ten years for the national authorities. The Declaration of conformity must be drawn for which device was issued.
A copy of the EC declaration of conformity shall be annexed to the instrument.
6. authorised representative, the obligations of the manufacturer referred to in the Nos. 2 and 5 can be fulfilled by his authorised representative, on his behalf and under his responsibility, if they are set in the order.
Module H: compliance on the basis of a comprehensive quality assurance
1. the conformity on the basis of a full quality assurance is the conformity assessment procedure with the manufacturer in the Z meets the 2 and 5 these obligations and guarantees and on their own responsibility declares that the measuring instruments concerned satisfy the requirements of this regulation.
2. making the manufacturer operates an approved quality assurance system for development, production, final product inspection and testing of the measuring instruments concerned to no. 3; It is subject to monitoring after no. 4.
(b) each for a model of each dial meter category, on the basis of these documents it must be possible the technical documentation described in § 14, to assess the conformity of the equipment with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the requirements list and the design, the manufacture and operation of this device are to capture, as far as they are for the assessment of relevance.
c) the documentation concerning the quality assurance system and d) a written declaration that the same application with any other notified body has previously been submitted.
3.2. the quality assurance system ensures conformity of the instruments with the requirements of this regulation.
Contain in particular an adequate description the following points: a) quality objectives and the organizational structure, responsibilities and powers of the Executive Board in relation to the design and quality of the device.
b) technical design specifications, including the standards be applied, and if the relevant harmonised standards and/or normative documents are - not fully applied, the means by which will, be used to ensure that the essential requirements applicable to measuring instruments this regulation using other relevant technical specifications will be met
c) control the development and design verification techniques, processes and systematic actions that will be used in the development of the instruments pertaining to the relevant instrument category
d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions;
e) before, during and investigations carried out after manufacturing and testing frequency;
f) quality-related records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned;
(g) funds will be used to monitor the achievement of the required design and quality of the device, as well as the effective operation of the quality assurance system.
The audit team reviewed the in Z 3.1 lit. b referred to technical documentation, to ensure that the manufacturer able is to identify the relevant requirements of this regulation and making the necessary verifications, to ensure conformity of the product with these requirements.
The decision having regard to used the manufacturer or his authorised representative. The notification must contain the conclusions of the audit and the reasoned of assessment decision.
4.2. the manufacturer grants access to the development, manufacturing, inspection, testing and storage facilities of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;
(b) the quality records provided for in the development-related part of the quality assurance system, such as results of analyses, calculations, tests;
(c) quality records provided for in the manufacturing-related part of the quality assurance system as test reports, inspection and calibration data, reports on the qualifications of the personnel concerned.
4.3. the notified body shall regularly conducts audits to ensure that the manufacturer maintains the quality assurance system and applies and passes him a corresponding report.
4.4. Additionally, the notified body the manufacturer may carry out unannounced visits. During these visits, the notified body may, if necessary, carry out tests on appliances or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.
The manufacturer shall affix the CE marking, the supplementary metrology marking in accordance with this regulation and under the responsibility of the notified body referred to in 3.1 Z whose identification number on each unit, that meets the applicable requirements of this regulation.
6 the manufacturer for a period of ten years from the placing on the market of the equipment for the national authorities, following documents provides: a) the technical documentation referred to in 3.1; Z
(b) the documentation concerning the quality assurance system in accordance with Z 3.1;
(c) the information relating to the change in accordance with Z 3.5 in its approved form;
(d) the decisions and reports of the notified body according to the Z 3.5, 4.3 and 4.4.
Module H1: Compliance on the basis of a full quality assurance with design examination
1. the conformity on the basis of a full quality assurance with design examination is the conformity assessment procedure, in which the manufacturer in the Z meets the 2 and 6 obligations referred to and to ensure and on their own responsibility declares that the measuring instruments concerned satisfy the requirements of the regulation.
2. making the manufacturer operates an approved quality assurance system for development, production, final product inspection and testing of the relevant instrument to no. 3; It is subject to monitoring after Z 5. The suitability of the technical design of the measuring equipment must be tested in accordance with no. 4.
The application contains the following: a)
Name and address of the manufacturer and, if the application is lodged by the authorised representative, also its name and address;
(b) all relevant information for the instrument category envisaged;
(c) the documentation concerning the quality assurance system;
(d) a written statement that is filed the same request with any other notified body.
3.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in 3.2 Z. In each part of the quality assurance system, which complies with the corresponding specifications of the relevant harmonised standard, it comes from a conformity with these requirements.
It announces its decision to the manufacturer or his authorised representative. The notification must contain the conclusions of the examination and the reasoned of assessment decision.
3.6. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.
4. design review 4.1.
At the in Z 3.1 notified body, the manufacturer must apply the consideration of the draft.
4.2: the application provides information on design, manufacture and operation of the device and allows an assessment of compliance with the applicable requirements of the regulation.
It contains a) name and address of the manufacturer;
(c) the technical documentation described in section 14. On the basis of these documents, it must be possible to evaluate the conformity of the equipment with the relevant requirements; they must contain a proper risk analysis and evaluation. They capture the design and operation of the device, unless they are for the assessment of relevant.
(d) the supporting evidence for a reasonable solution through the technical design. This supporting evidence include a reference to all of the documents taken were, in particular if the relevant harmonised standards and/or normative documents were not fully applied, and, where appropriate, include the results of tests conducted in accordance with other relevant technical specifications in an appropriate laboratory of the manufacturer or on his behalf and under his responsibility in another testing laboratory.
4.3. the notified body shall examine the application and exhibits a EU design examination certificate to the manufacturer where the design meets the requirements applicable to the device in this regulation. The certificate must contain the name and address of the manufacturer, the results of the tests, any conditions for its validity and the necessary data for identification of the approved design. One or more attachments can be attached to this certificate.
The certificate and its annexes contain all relevant information, enabling to assess the conformity of the manufactured instruments with the examined design and, where appropriate, a check is after her commissioning. In order to the conformity of the manufactured instruments, when they are properly adjusted with appropriate means provided for that purpose, evaluate in terms of repeatability of measuring performance with the approved design, in particular the following shall be indicated: a) the metrological characteristics of the device design.
(b) that to ensure the integrity of the instruments (sealing, identification of software, etc.) necessary measures;
(c) other information which are necessary to identify the device and to the Visual inspection as regards its external compliance with the draft;
(d) where appropriate, other specific details that are required for the verification of the characteristics of manufactured instruments;
(e) in the case of a device of of part of all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments.
The notified body created an audit report in this regard and holds it for the Member State which has notified it. Without prejudice to § 19 para 14 the notified body released the content of this report, or parts of them only with the consent of the manufacturer. The certificate is valid for ten years from their date of issue and may be renewed thereafter for another ten years. The draft is not the applicable requirements of the regulation, the notified body refuses to issue an EU design examination certificate and shall inform the applicant about where she explained their refusal in detail.
4.4. the notified body informed himself continuously of any changes in the generally acknowledged State of the art; These indicate that the approved type no longer complies with the applicable requirements of this regulation, it decides whether such changes require further investigations. This is the case, so the notified body shall inform the manufacturer accordingly.
The manufacturer shall keep the notified body that has issued the EU design examination certificate of all modifications to the approved design that may affect its compliance with the essential requirements of this regulation or the conditions for validity of the certificate. Such modifications require additional approval by the notified body that has issued the EU design examination certificate, in the form of an addition to the original EU design examination certificate.
4.5. each notified body informed their notifying authority over the EU design examination certificates and/or any additions to that has issued it or withdrawn, and submit their notifying authority at regular intervals or at the request a list of all certificates and/or additions to, who has denied, suspended or otherwise restricted.
The notified body shall so long kept a copy of the EU test certificate together with the annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the period of validity of the certificate.
4.6. the manufacturer a copy of EU design examination certificate, its annexes and additions together with the technical documentation provides for ten years after the placing on the market of the equipment for the national authorities.
5. surveillance under the responsibility of the notified body 5.1.
5.2. the manufacturer grants access to the development, manufacturing, inspection, testing and storage facilities of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;
(b) the quality records provided for the development area in the quality assurance system, such as results of analyses, calculations, tests, etc.;
(c) the quality records provided for in the manufacturing-related part of the quality assurance system such as inspection reports, test and calibration data, qualification reports of the personnel concerned, etc.
5.3. the notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes him a corresponding report.
5.4. in addition the notified body the manufacturer may carry out unannounced visits. During these visits, the notified body may, if necessary, carry out tests on appliances or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.
The manufacturer must affix the CE marking, the supplementary metrology marking in accordance with this regulation and under the responsibility of the notified body referred to in 3.1 Z whose identification number on each unit, which meets the relevant requirements of this regulation.
6.2 the manufacturer issues a written EC declaration of conformity for each model of appliance and holds them after the placing on the market of the device for ten years for the national authorities. In the EU Declaration of conformity is to specify which device model it was issued; the number of the design examination certificate is also performing.
7 the manufacturer for a period of ten years from the placing on the market of the equipment for the national authorities, following documents provides: a) the documentation concerning the quality assurance system in accordance with Z 3.1;
(c) the decisions and reports of the notified body according to the Z 3.5, 5.3 and 5.4.
8. authorised representative the authorised representative of the manufacturer can submit the application referred to in the Z 4.1 and 4.2 and in the Z on his behalf and under his responsibility the obligations that 3.1, 3.5, 4.4, 4.6, 6 and 7 above, if they are set in the order.
1. device model/device (product, type, batch or serial number): 2. name and address of the manufacturer and, where appropriate, his authorised representative: 3. bears sole responsibility for issuing this Declaration of conformity the manufacturer.
4. object of the Declaration (name of the device for the purpose of traceability; it can contain an image, unless this is necessary for the identification of the device): 5. the above subject to the Declaration complies with the relevant Community harmonisation of the Union: 6 specifying of the relevant harmonised standards or normative documents that have been applied or indication of other normative documents or other technical specifications, for which conformity is declared : 7 (possibly :)) The notified body (identification number name)... has... (Description of activities)... and following certificate issued: 8 additional information: signed for and on behalf of: (place and date of issue): (name, function) (signature): article 2
On the basis of section 18 Z 4 and § 49 para 2 of the measurement and calibration Act (MEG), Federal Law Gazette No 152/1950, as last amended by Federal Law Gazette I no. 148/2015 is prescribed:
Ordinance of the Federal Minister for Economic Affairs on mutual recognition in the field of measurement and calibration system, Federal Law Gazette No. 858/1993, as last amended by the regulation Federal Law Gazette II No. 274/2006, is amended as follows:
1. the sections 1 and 2 are:
„§ 1. The reciprocity and equivalence regarding provisions on bottles as Maß containers will, unless it on 75/107/EEC on the approximation of the laws of the Member States relating to bottles as Maß containers, OJ No. L 42 of the 15.2.1975 based p. 14, noted for the States specified in the annex.
§ 2. The reciprocity and equivalence on the carried out of filling quantities of prepackages is, if on the Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the certain products by weight or by volume of (OJ No. L 46 of 21 February 1976, p. 1; Annex II, IX. measuring instruments, section 15 of the EEA Agreement), as amended by Directive 78/891/EEC (OJ No. L 311 of 4 November 1978, p. 21), as amended by Directive 2007/45 laying down nominal quantities for products in prepackages, repealing Directives 75/106/EEC and 80/232/EEC and amending Directive 76/211/EEC of the Council, OJ No. L 247 of September 21, 2007 determined S 17, for the States that are specified in the system."
2. the introductory sentence in article 3 is as follows:
"The reciprocity and equivalence regarding EC-approval and the initial EC verification is provided on the directive 2009/34/EC concerning common rules on measuring instruments and measuring and testing (recast), OJ" "No. L 106 of April 28, 2009 S 7, are based, for the States specified in the system for the following directives:"
3. § 3 No. 7 is cancelled.
"(1) the recognition of licences referred to in article 3 and thus associated Z 1, 4, 9, 12 and 18 is with 30 November 2015 lifted."
5. paragraph 4 section 4:
"(4) the mutual recognition of authorisations in accordance with article 3 and thus associated Z 10 will be repealed 30 November 2015."
6. in article 4, paragraph 5, the letters "EEC" is replaced by the letters "EC".
7 be added following paragraph 7 and 8 in section 4:
"(7) the recognition of the approval in accordance with § 3 and thus associated Z 6 is repealed.
The EC approvals issued to the 30th November 2015 continue to apply (8) for the instruments referred to in paragraphs 1 and 4 to their validity."
8. the provisions of the annex are:
"Member States of the European Union, Contracting States of the EEA, Switzerland and Turkey"
On the basis of article 21 of the measurement and calibration Act (MEG), Federal Law Gazette No. 152/1950, as last amended by Federal Law Gazette I no. 148/2015, is prescribed:
Dispensing vascular regulation, Federal Law Gazette No. 572/1991, as last amended by regulation Federal Law Gazette II No. 274/2006, is amended as follows:
1. in section 8, paragraph 2, the designation "I" is eliminated after the word "System".
2. in the introductory phrase of the plant, the string is "Federal Law Gazette II No. 274/2006" by the string "BGBl. II No. 31 / 2016" replaced.
3. in the system Z 1.2 is the phrase "flat surface" replaced with the phrase "horizontal area".
4. in the annex the formula is under no. 2 in table 1 "+ 5 ml + 2.5%" by the formula "+ (5 ml + 2.5%)" replaced.
Change the calibration accreditation regulation of the Federal Minister for Economic Affairs concerning the admission of instruments or instrument parts to the calibration as well as the characters to use for the approval and verification and stamp
On the basis of §§ 18 Z 4, 36 para 3 and 38 paragraph 8 of the measurement and calibration Act (MEG), Federal Law Gazette No. 152/1950, as last amended by the Federal Act Federal Law Gazette I no. 148/2015, is prescribed:
The calibration approval regulation, Federal Law Gazette No. 785/1992 as last amended by regulation BGBl. II No 172/2008, is amended as follows:
"The Member States of the European Union, the Contracting States of the EEA, (3) the term"Domestic"are to equate Switzerland and Turkey."
2. paragraph 1a:
'section 1a. "This Regulation shall apply for admissions to the calibration for a conformity assessment in accordance with the regulation laying down conformity assessment procedures relating to non-automatic weighing scales, Federal Law Gazette II No. 30 / 2016, or the meter regulation 2016, Federal Law Gazette II No. 31/2016, not is provided."
3. in article 2, paragraph 3, the phrase is "Article 18a, paragraph 2 or of paragraph 40 Z 1-Z 3" by the phrase "§ 40 Z 1 to 2" replaced.
4. in § 2 para 4, § 3 para 3, § 4 par. 1 Z 10 and in the entire section IX, the string 'EEC' is replaced by the string "EC".
5. the section 26 be attached following paragraph 6 and 7:
"(6) a grant of EC type approvals is inadmissible from the 30th November 2015.
(7) if the validity of the EC type-approval is not renewed, so this approval however still applies for instruments that are already in use."
Amendment of the regulation of the Federal Minister for Economics and labour concerning the recognition of calibration technical assessments
On the basis of section 18 Z 3 and § 49 para 2 of the measurement and calibration Act (MEG), Federal Law Gazette No 152/1950, as last amended by Federal Law Gazette I no. 148/2015, is prescribed:
Ordinance of the Federal Minister for Economic Affairs and labour concerning the recognition of calibration technical trials, Federal Law Gazette II No. 169/2000, as last amended by the regulation Federal Law Gazette II No. 274/2006, is amended as follows:
1 § 1 para 1 subpara 1 including the introduction sentence of para 1 is:
"(1) instruments which have been manufactured in another Member State of the European Union, a Contracting State of the agreement, Switzerland or Turkey, foreign calibration technical examination of domestic is equivalent, if"
1. the instruments a) no EC initial verification in accordance with Directive 2009/34/EC concerning common rules on measuring instruments and measurement and testing, OJ No. L 106 of April 28, 2009 p. 7, get can;
(b) No CE marking on the basis of the directive 2014/31/EC on the approximation of the laws of the Member States concerning the provision of non-automatic scales on the market (recast), OJ L 96 of the 29.03.2014 can get no. p. 107, and do not fall in the scope of this directive;
(c) No CE marking on the basis of 2014/32/EU directive on the harmonisation of legislation of Member States concerning the provision of measuring instruments on the market (recast), OJ L 96 of the 29.03.2014 can get no. S. 149, and do not fall in the scope of this directive;"
2. in article 2, paragraph 1, Z 2 eliminates the phrase "(§ 58 MEG)" and the word sequence "accreditation Act, Federal Law Gazette no 486/1992, as last amended by Federal Law Gazette No. 430/1996" by the phrase "accreditation Act 2012, Federal Law Gazette I no. 28/2012, as amended by Federal Law Gazette I no. 40/2014" replaced.
3. in article 2, paragraph 4, the phrase "(§ 58 MEG) is eliminated".
4. paragraph 3:
„§ 3. "By the calibration technical agencies are fees in the amount of the fees in accordance with § 14 of the calibration fees regulation 2013, Federal Law Gazette II No. 311/2013, to be paid."
5. According to § 6 the following section 7 is added:
"§ 7 section 1 para 1 No. 1 as amended by the regulation BGBl. II Nr 31/2016 20 April 2016 into force."