BS EN 15267-1-2009 Air quality — Certification of automated measuring systems Part 1 General principles.pdf

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1、? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? BS EN 15267-1:2009BS EN 15267-1:2009 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15267-1 March 2009 ICS 13.040.99 English Version Air quality - Certification of automated measuring systems - Part 1: General principles Qualit de l

2、air - Certification des systmes de mesurage automatiss - Partie 1 : Principes gnraux Luftbeschaffenheit - Zertifizierung von automatischen Messeinrichtungen - Teil 1: Grundlagen This European Standard was approved by CEN on 14 February 2009. CEN members are bound to comply with the CEN/CENELEC Inter

3、nal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN memb

4、er. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN membe

5、rs are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, S

6、witzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. N

7、o. EN 15267-1:2009: E BS EN 15267-1:2009BS EN 15267-1:2009 EN 15267-1:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1Scope 5 2Normative references 5 3Terms and definitions .6 4Abbreviations .7 5Principles 7 5.1Performance testing of the automated measuring system .7 5.2Initial assessment of th

8、e AMS manufacturers quality management system .8 5.3Certification 8 5.4Surveillance 8 6Roles and responsibilities 9 6.1General 9 6.2Roles and responsibilities of the manufacturer .9 6.3Roles and responsibilities of the test laboratory .9 6.4Roles and responsibilities of the relevant body 10 7Certifi

9、cation procedure 11 7.1General . 11 7.2Performance testing of the automated measuring system 11 7.3Initial assessment of the manufacturers quality management system . 11 7.4Certification . 11 7.5Surveillance . 12 7.6Review of certifications 13 Annex A (informative) Application and assessment process

10、es 14 Annex B (informative) Example certificate template . 15 Bibliography . 17 ? BS EN 15267-1:2009BS EN 15267-1:2009 EN 15267-1:2009 (E) 3 Foreword This document (EN 15267-1:2009) has been prepared by Technical Committee CEN/TC 264 “Air quality”, the secretariat of which is held by DIN. This Europ

11、ean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by September 2009. Attention is drawn to the possibility that some of the

12、elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document is Part 1 of a series of European Standards: EN 15267-1, Air quality Certification of automated measuring systems Part 1: Gener

13、al principles EN 15267-2, Air quality Certification of automated measuring systems Part 2: Initial assessment of the AMS manufacturers quality management system and post certification surveillance for the manufacturing process EN 15267-3, Air quality Certification of automated measuring systems Part

14、 3: Performance criteria and test procedures for automated measuring systems for monitoring emissions from stationary sources According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Bel

15、gium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. ? BS EN 15267-1:2

16、009BS EN 15267-1:2009 EN 15267-1:2009 (E) 4 Introduction The certification of automated measuring systems (AMS) supports the requirements of certain Directives of the European Union (EU), which require, either directly or indirectly, that AMS comply with performance criteria, maximum permissible mea

17、surement uncertainties and testing requirements. These Directives include the Directive on the limitation of emissions of certain pollutants into the air from large combustion plants 1, the Directive on the incineration of waste 2 and the Framework Directive on ambient air quality assessment and man

18、agement 3 and the associated daughter directives 4, 5, 6 and 7. The responsibility for approving AMS for monitoring ambient air quality under Directive 96/62/EC lies with the national competent authority or a body designated by the EU member state. No explicit requirement for approving AMS for monit

19、oring emissions from stationary sources is defined in the relevant EU Directives, although the competent authorities in some EU member states have such arrangements in place. In some EU member states the competent authority delegates the responsibility for approval of AMS to a certification body acc

20、redited to EN 45011 by national accreditation bodies. In some EU member states the competent authority cannot be accredited by external bodies, in others they may be. These approaches have built up over many years and reflect the different administrative and legal arrangements that exist in the EU m

21、ember states. In order to recognize these different approaches, this European Standard uses the collective term “relevant body” when referring to competent authority or certification body. The terms “competent authority” and “certification body” are only used where it is necessary to be specific for

22、 the purpose of clarity in the way in which a requirement applies under the different approaches. The European Standard EN 45011 specifies general criteria that a certification body operating product certification shall follow if it is to be recognized at a national or European level as competent an

23、d reliable in the operation of a product certification system, irrespective of the sector involved. It is intended for the use of accreditation bodies concerned with recognizing the competence of certification bodies. EN 45011 is identical to ISO/IEC Guide 65. The document EA-6/01 8 published by the

24、 International Accreditation Forum (IAF) provides guidelines on the application of EN 45011. The purpose of EA-6/01 is to harmonise the worldwide application of EN 45011 by accreditation bodies as an important step towards mutual recognition between certification bodies under the IAF Multilateral Ag

25、reement (MLA). EN 45011 recognizes that these general criteria may have to be supplemented when applied to a particular sector. This European Standard provides guidance on the application of EN 45011 to the certification of AMS for monitoring ambient air quality and emissions from stationary sources

26、. It is Part 1 of a three part series of European Standards, which specify common requirements for the certification of AMS in EU member states. This European Standard defines common procedures and requirements for the certification of AMS to facilitate mutual recognition by the relevant bodies and

27、thereby minimise administrative and cost burdens on AMS manufacturers seeking certification in multiple member states. It also describes the roles and responsibilities of manufacturers, test laboratories, certification bodies (for quality management systems) and relevant bodies under these procedure

28、s. ? BS EN 15267-1:2009BS EN 15267-1:2009 EN 15267-1:2009 (E) 5 1 Scope This European Standard specifies the general principles, including common procedures and requirements, for the product certification of automated measuring systems (AMS) for monitoring ambient air quality and emissions from stat

29、ionary sources. This product certification consists of the following sequential stages: a) performance testing of an automated measuring system; b) initial assessment of the AMS manufacturers quality management system; c) certification; d) surveillance. This European Standard applies to the certific

30、ation of all AMS for monitoring ambient air quality and emissions from stationary sources for which performance criteria and test procedures are available in European Standards. 2 Normative references The following referenced documents are indispensable for the application of this document. For date

31、d references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 14211, Ambient air quality Standard method for the measurement of the concentration of nitrogen dioxide and nitrogen monoxide by chemiluminescenc

32、e EN 14212, Ambient air quality Standard method for the measurement of the concentration of sulphur dioxide by ultraviolet fluorescence EN 14625, Ambient air quality Standard method for the measurement of the concentration of ozone by ultraviolet photometry EN 14626, Ambient air quality Standard met

33、hod for the measurement of the concentration of carbon monoxide by nondispersive infrared spectroscopy EN 14662-3, Ambient air quality Standard method for measurement of benzene concentrations Part 3: Automated pumped sampling with in situ gas chromatography EN 15267-2, Air quality Certification of

34、automated measuring systems Part 2: Initial assessment of the AMS manufacturers quality management system and post certification surveillance for the manufacturing process EN 15267-3, Air quality Certification of automated measuring systems Part 3: Performance criteria and test procedures for automa

35、ted measuring systems for monitoring emissions from stationary sources EN 45011, General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996) EN ISO 9001, Quality management systems Requirements (ISO 9001:2000) EN ISO/IEC 17021, Conformity assessment Requirements f

36、or bodies providing audit and certification of management systems (ISO/IEC 17021:2006) EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005) ? BS EN 15267-1:2009BS EN 15267-1:2009 EN 15267-1:2009 (E) 6 3 Terms and definitions For the p

37、urposes of this document, the following terms and definitions apply. 3.1 automated measuring system AMS entirety of all measuring instruments and additional devices for obtaining a result of measurement NOTE 1 Apart from the actual measuring device (the analyser), an AMS includes facilities for taki

38、ng samples (e.g. probe, sample gas lines, flow meters and regulator, delivery pump) and for sample conditioning (e.g. dust filter, pre- separator for interferents, cooler, converter). This definition also includes testing and adjusting devices that are required for functional checks and, if applicab

39、le, for commissioning. NOTE 2 The term “automated measuring system” (AMS) is typically used in Europe. The terms “continuous emission monitoring system” (CEM) and “continuous ambient-air-quality monitoring system” (CAM) are also typically used in the UK and USA. 3.2 relevant body competent authority

40、 or certification body, nominated by a competent authority or EU member state, that carries out the certification of automated measuring systems 3.3 competent authority organisation which implements the requirements of EU Directives and regulates installations, which must comply with the requirement

41、s of applicable European Standards 3.4 certification body any body operating a product certification system or any body accredited to EN ISO/IEC 17021 for the certification of quality management systems 3.5 manufacturer organisation, situated at a stated location or locations, that carries out or co

42、ntrols such stages in the manufacture, assessment, handling and storage of a product that enables it to accept responsibility for continued compliance of the product and its certification, and undertakes all obligations in that connection NOTE The term “manufacturer“ is used instead of “organisation

43、“ as used in EN ISO 9001. For the purpose of this document they are interchangeable. 3.6 test laboratory laboratory accredited to EN ISO/IEC 17025 for carrying out the performance tests on automated measuring systems in accordance with applicable European Standards 3.7 product automated measuring sy

44、stem 3.8 technical file record of the reference documents and design changes to the reference documents 3.9 reference document document that controls the manufacture and design of an AMS and is referenced in the test report ? BS EN 15267-1:2009BS EN 15267-1:2009 EN 15267-1:2009 (E) 7 NOTE Reference

45、documents can include drawings, specifications, instructions and computer code. 3.10 related document document not referenced in the test report NOTE A related document can be used, for example, for the detailed manufacture of component parts. 3.11 certification range range over which the automated

46、measuring system is tested and certified for compliance with the relevant performance criteria NOTE 1 The lower limit is typically the detection limit of the AMS and often considered to be zero. NOTE 2 Generally, the lower the certification range, the better the performance of the AMS. Also an AMS typically performs satisfactorily at higher values over the measurement range. 3.12 surveillance systematic iteration of conformity assessment activities as a

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