CLC TR 50442-2018 Guidelines for product committees on the preparation of standards related to human exposure from electromagnetic fields.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Guidelines for product committees on the preparation of standards related to human exposure from electromagnetic fieldsPD CLC/TR 50442:2018TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CLC/TR 50442 January 2018

2、 ICS 01.120; 13.280; 29.020 Supersedes CLC/TR 50442:2005 English Version Guidelines for product committees on the preparation of standards related to human exposure from electromagnetic fields Lignes directrices pour les comits de produit concernant ltablissement des normes relatives lexposition hum

3、aine aux champs lectromagntiques Leitfaden fr Produktkomitees zur Ausarbeitung von Normen in Bezug auf die Sicherheit von Personen in elektromagnetischen Feldern This Technical Report was approved by CENELEC on 2018-12-25. CENELEC members are the national electrotechnical committees of Austria, Belg

4、ium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain

5、, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CENELEC All rights

6、of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. CLC/TR 50442:2018 E National forewordThis Published Document is the UK implementation of CLC/TR 50442:2018. It supersedes PD CLC/TR 50442:2005, which is withdrawn.The UK participation in its preparation was

7、 entrusted to Technical Committee GEL/106, Human exposure to low frequency and high frequency electromagnetic radiation.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a con

8、tract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 99255 1ICS 29.020; 01.120; 13.280Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was publish

9、ed under the authority of the Standards Policy and Strategy Committee on 28 February 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CLC/TR 50442:2018TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CLC/TR 50442 January 2018 ICS 01.120; 13.280; 29.020

10、Supersedes CLC/TR 50442:2005 English Version Guidelines for product committees on the preparation of standards related to human exposure from electromagnetic fields Lignes directrices pour les comits de produit concernant ltablissement des normes relatives lexposition humaine aux champs lectromagnti

11、ques Leitfaden fr Produktkomitees zur Ausarbeitung von Normen in Bezug auf die Sicherheit von Personen in elektromagnetischen Feldern This Technical Report was approved by CENELEC on 2018-12-25. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cypr

12、us, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turke

13、y and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CENELEC All rights of exploitation in any form

14、and by any means reserved worldwide for CENELEC Members. Ref. No. CLC/TR 50442:2018 E PD CLC/TR 50442:2018CLC/TR 50442:2018 (E) 2 Contents Page Contents . 2 European foreword 3 Introduction 4 1 Scope . 5 2 Types of EMF product-related standards . 5 3 Other types of standard . 6 4 Structure of EMF st

15、andards and general quality principles 6 5 Titles of EMF standards . 7 6 Drafting of an EMF product standard . 7 7 Coordinating role of CENELEC TC 106X for EMF standards prepared by other CENELEC committees 10 Annex A (informative) Example Annexes ZZ . 11 PD CLC/TR 50442:2018CLC/TR 50442:2018 (E) 3

16、European foreword This document (CLC/TR 50442:2018) has been prepared by CLC/TC 106X, “Electromagnetic fields in the human environment“. This document supersedes CLC/TR 50442:2005. This report has been accepted by ETSI and CEN as the basis for the development of electromagnetic fields (EMF) standard

17、s. The main changes with respect to the previous edition of CLC/TR 50442 are: a) Update of the introduction to take into account Directive 2014/53/EU, Directive 2014/35/EU and Directive 2013/35/EU; b) Replacement of Clause 1 “Purpose“ with new Clause 1 “Scope“; c) Replacement of Clause 2 with new Cl

18、ause 2; d) Replacement of Subclause 2.6 with new Clause 4; e) Replacement of Clause 3 with new Clause 6; f) Replacement of Clause 4 with new Clause 3; g) Added requirements of Directives 2013/35/EU and 2014/53/EU to Clause 5 and renumbered Clauses 5 to 7; h) Added new Clause 5 “Titles of EMF standar

19、ds“; i) Added new Annex A with examples of Annexes ZZ. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights. PD CLC/TR 50442:2018CLC/TR 50442:2018 (E)

20、4 Introduction Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC Text with EEA relevance OJ L 153, 22.5.2014 is

21、applicable from 13 June 2016. Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (recast) OJ

22、 L 96, 29 March 2014 is applicable from 20 April 2016. The European Commission has given CENELEC, the task of preparing harmonized standards for the implementation of these Directives under Mandate M/536 and M/511 to provide a presumption of conformity to their Essential Safety Requirements. The Ess

23、ential Safety Requirements of the Directives include safety in relation to human exposure to electromagnetic fields. In addition, Directive 2013/35/EU of 26 June 2013, on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electroma

24、gnetic fields). Official Journal, L179, of 2013-6-29, p. 121 is applicable from 29 June 2013. The European Commission has given CENELEC, the task of preparing standards for the implementation of this Directive under Mandate M/351. PD CLC/TR 50442:2018CLC/TR 50442:2018 (E) 5 1 Scope The purpose of th

25、is Technical Report is to give advice on, and explanation of, the preparation of suitable EMF standards. It also aims to ensure that relevant deliverables from all CLC TCs will accurately reflect the current policy and legislative background on EMF exposure. 2 Types of EMF product-related standards

26、There are two types of EMF standards that are related to the assessment of EMF emissions from products: basic standards and product standards. Basic EMF standards define measurement and calculation methods, test instrumentation and test set-ups to be used for the evaluation of compliance with limits

27、 on human exposure to electromagnetic fields. General types or ranges of assessment criteria appropriate to specific evaluation methods or procedures may be given, but a basic standard includes neither prescribed limits nor compliance criteria. Since basic standards define the applicable measurement

28、 and calculation methods, they constitute the broad foundation on which product standards are based on. In general, product standards do not include applicable measurement or calculation methods, test instrumentation or test set-ups but refer for that purpose to the applicable basic standard or stan

29、dards. Some product standards may determine that only certain parts of a basic standard apply while other parts of that basic standard do not. All EMF product standards shall include normative references to limits on human exposure to electromagnetic fields, and compliance assessment criteria applic

30、able to products covered by Directives 2013/35/EU and 2014/53/EU. Both basic standards and product standards can be either product-specific or generic (covering a number of different products). Moreover, they can address placing-on-the-market, putting-into-service or in-situ (i.e. dedicated to serve

31、 a special purpose or situation). Table 1 gives an overview of the characteristics of the different types of product-related standards. They are described more fully in Annex I. Table 1 Basic vs product standards Type Contents Aims Basic Measurement and calculation methods Instrumentation Test set-u

32、p Types and ranges of assessment criteria No limits or compliance criteria Reference documents Called up by product standards or freestanding No conformance criteria, e.g. limits for products (Not capable of being referenced in the OJEU list) Product Scope describing to which products they apply Nor

33、mative limits Compliance criteria Refer to basic standards for assessment methods (no repetition) Conformance criteria for products Intended to be referenced in the OJEU list for the relevant Directive Table 2 Product specific vs generic standards Type Aim Nature Product-specific Specific to a parti

34、cular product, family of products or range of products May be a basic or product standard Generic Can apply to a range of different products e.g. low power products or products not covered by any other product standard May be a basic or product standard PD CLC/TR 50442:2018CLC/TR 50442:2018 (E) 6 Ta

35、ble 3 Placing-on-the-market, putting-into-service and in situ standards Type Purpose Nature Placing-on-the-market Assessment of a product to allow it to be placed on the market, i.e. made available for the first time to end-users Assessment of a single product, usually in isolation. May be a basic o

36、r product standard May be product-specific or generic Putting-into-service Assessment of an installed product in its operating environment at the point at which it is put-into-service, taking account of other EMF sources already present. Where applicable, to give guidance on installation practices i

37、n order not to have accessible areas where the exposure limits are exceeded May be a basic or product standard May be product-specific or generic In- situ Assessment of an already-installed product in its operating environment at any time. May be a basic or product standard May be product-specific o

38、r generic 3 Other types of standard Other EMF standards that are not directly related to product performance include those written to support the implementation of Directive 2013/35/EU (The Occupational EMF Directive). These are not harmonized and may have structures and content other than as define

39、d for product or basic standards in Clause 2. 4 Structure of EMF standards and general quality principles It is intended that product standards should make reference to the basic standards without repeating their detailed contents. Basic standards should not contain compliance criteria and will not

40、be referenced in the list of harmonized standards published in the Official Journal of the European Union (OJEU). The OJEU list will include only references to product standards, i.e. standards that are capable of providing a direct presumption of conformity of products with the Essential Safety Req

41、uirements of Directives 2014/35/EU and 2014/53/EU. The following general quality principles for standards are emphasized: Overall requirement: the title and scope of a standard shall indicate whether it is a basic or a product standard and if is a product standard, further determination of the purpo

42、se as defined in Clause 2 above is required. A standard shall lead to reproducible results: it shall be robust against usual variations in the measuring set-up or measuring devices. A standard shall be unambiguous: It shall not be possible to give multiple interpretations to the standard. All types

43、of standards shall take uncertainty into consideration, e.g. by giving maximum allowed uncertainty. Measurement uncertainties shall be treated in line with the ISO “Guide to the expression of uncertainty in measurement“ ISO/IEC GUIDE 98-3:2008 Edition 1.0 (2008-09-30) - Uncertainty of measurement Pa

44、rt 3: Guide to the expression of uncertainty in measurement (GUM:1995). According to the common practice in EMC standards, the expanded uncertainty shall be evaluated using a confidence interval of 95 %. The measurement method shall be as simple as possible for fulfilling the requirements of what ne

45、eds to be measured. Sophisticated methods or equipment shall be avoided where possible. Methods easily applicable have the lowest chance of errors. Measurement methods shall be as economical and time-saving as possible for their purpose. The method shall be tested in practice by multiple test houses

46、 before the standard be subject to voting. Overall requirement: the method shall be valid for its purpose. The method shall be such that its outcome leads to a conclusion whether the EMF exposure from the apparatus falls within the specified limits. PD CLC/TR 50442:2018CLC/TR 50442:2018 (E) 7 The st

47、andard shall acknowledge the requirements of all stakeholders including those organizations representing interests of specific societal groups, e.g. people with disabilities or those needing other particular considerations and including authorities representing public health. To this end, Partner Or

48、ganizations shall be encouraged strongly to nominate experts to CENELEC WGs. 5 Titles of EMF standards The title of any EMF standard shall reflect clearly whether it is a Basic standard or a Product standard. If it is a basic standard, the words Basic standard shall be preceded by the word “generic”

49、 if applicable, and followed by one of either “placing-on-the-market,” “putting-into-service” or “in situ” in brackets. If it is a product standard, the words Product standard shall be preceded by the word “generic” if applicable, and followed by one of either “placing-on-the-market,” “putting-into-service” or “in situ” in brackets. In addition, the title shall further contain information for users, including the frequency range Standards other than those defined in Clause 2 shall have titles appropriate