BS PD IEC TR 62936-2016 Test method development Guidelines for substance selection《试验方法发展 物质选择指南》.pdf

1、Test method development Guidelines for substance selection PD IEC/TR 62936:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementation of IEC/TR 62936:2016. The UK participation in its preparation was entru

2、sted to Technical Committee GEL/111, Electrotechnical environment committee. 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 contract. Users are responsible for its corre

3、ct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 93074 4 ICS 13.020.01; 19.040 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Po

4、licy and Strategy Committee on 30 November 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/TR 62936:2016 IEC TR 62936 Edition 1.0 2016-11 TECHNICAL REPORT Test method development Guidelines for substance selection INTERNATIONAL ELECTROTECHNICAL COMMI

5、SSION ICS 13.020.01; 19.040 ISBN 978-2-8322-3695-6 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. 2 IEC TR 62936:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope 6 2 Normative ref

6、erences 6 3 Terms, definitions and abbreviated terms 6 3.1 Terms and definitions 6 3.2 Abbreviated terms . 6 4 Process flow 6 5 Process flow steps. 8 5.1 Chemical substance list 8 5.2 Substance filtering process . 8 5.3 Substance filtering criteria 10 Substance presence in final EEE product 10 5.3.1

7、Regulatory or market requirements 10 5.3.2Regional impact . 10 5.3.3Regulatory impact 10 5.3.4Intentional addition of substance . 11 5.3.5Strategic considerations 11 5.3.6Test method development 12 5.3.7 5.4 Existence of other related standards . 13 5.5 Final substance selection 13 (informative) Pil

8、ot study of RoHS II priority substances 14 Annex A Bibliography 16 Figure 1 Substance selection process 7 Table 1 Substance filtering criteria . 9 Table A.1 Pilot study result of RoHS II priority substances . 14 PD IEC/TR 62936:2016IEC TR 62936:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSI

9、ON _ TEST METHOD DEVELOPMENT GUIDELINES FOR SUBSTANCE SELECTION FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

10、 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referr

11、ed to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in

12、this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an internati

13、onal consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable

14、 efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publ

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16、 Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7

17、) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for co

18、sts (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct appli

19、cation of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare Interna

20、tional Standards. However, a technical committee may propose the publication of a Technical Report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC TR 62936, which is a Technical Report, has been pr

21、epared by IEC technical committee 111: Environmental standardization for electrical and electronic products and systems. The text of this Technical Report is based on the following documents: Enquiry draft Report on voting 111/410A/DTR 111/441/RVC Full information on the voting for the approval of t

22、his Technical Report can be found in the report on voting indicated in the above table. PD IEC/TR 62936:2016 4 IEC TR 62936:2016 IEC 2016 This document has been drafted in accordance with the ISO/IEC Directives, Part 2. The committee has decided that the contents of this document will remain unchang

23、ed until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific document. At this date, the document will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later

24、date. PD IEC/TR 62936:2016IEC TR 62936:2016 IEC 2016 5 INTRODUCTION The large number of chemical substances currently regulated or under consideration for regulation necessitates the need for the development of reliable and acceptable test methods to be used as one approach for conformity assessment

25、. For conformance demonstration, it is vital that interested parties agree that a particular test method is technically correct (i.e. provide reliable analytical results), is appropriate for the samples to be analysed, tested and vetted by technical experts, and is unbiased in its application. These

26、 criteria are generally fulfilled by test methods that are developed and published by a standards development organization (SDO) (e.g. IEC, ISO). Because of limited resources and the length of time needed to develop and validate these procedures, only a limited number of substances can be addressed

27、at any given time for test method development. This document provides a process for logically filtering, prioritizing and selecting candidate substances for development of test method standards. The objective of the filtering process is to partition the list of candidate substances into groups based

28、 on relative importance. Given that this document is intended for electrotechnical products, the candidate substances are largely drawn, but not exclusively, from the substance lists recorded in the IEC 62474 database 1 1on material declaration. The substances listed in the database are grouped into

29、 3 categories with brief descriptions given below: IEC Criteria 1 “currently regulated” or “explicitly included within an existing national law or regulation in an IEC member country”. The law or regulation is applicable to electrotechnical products and goes into force at a specific date. IEC Criter

30、ia 2 “for assessment” or substance or substance group that meets criteria 1 with the exception that the law or regulation does not cite a specific effective date for the requirements. IEC Criteria 3 “for information only” or does not meet requirement for either criteria 1 or 2. However, “there is a

31、recognized industry-wide common market requirement for reporting this substance or substance group in electrotechnical products”. NOTE Criterion/criteria is used in this document to denote a rule/principle for evaluating a substance against a set of requirements. The use of the term IEC criteria is

32、specific to the regulatory status of a particular substance as defined in the IEC 62474 standard. In addition to those substances that are under regulatory scrutiny, market requirements may also be of major consideration for the development of IEC test method standards. There are several very import

33、ant influences that may dictate the ability of a product to enter or be introduced into the marketplace. Examples of market driven requirements may include EPEAT (Electronic Product Environment Assessment Tool), Low Halogen initiative set by the electronics industry, Energy Star 2for energy efficien

34、t products and others. Although there are no legal obligations that electrotechnical equipment meet the requirements set forth in these initiatives, failure to do so may put the supplier at a severe competitive disadvantage. In many cases, the suppliers product may be disqualified for purchasing con

35、sideration for failure to meet these requirements. The filtering process is intended to screen out the majority of substances for consideration leaving only the “critical few” substances for further consideration. Due to the rapidly changing regulatory environment, the criteria used for filtering ma

36、y or may not be the most appropriate for the substances under consideration. Thus, some judgement needs to be exercised in interpreting the resulting scores. The final selection process is intended to allow the consideration of additional requirements or criteria that are not captured in the initial

37、 filtering process. Subjective criteria (relative importance is not measureable) may also be introduced. No attempt has been made to try to define the criteria in the final selection process given the changing requirements in both the regulatory and market environments. _ 1Numbers in square brackets

38、 refer to the bibliography. 2EPEAT and Energy Star are registered trademarks. This information is given for the convenience of users of this document and does not constitute an endorsement by IEC of these registered trademarks. PD IEC/TR 62936:2016 6 IEC TR 62936:2016 IEC 2016 TEST METHOD DEVELOPMEN

39、T GUIDELINES FOR SUBSTANCE SELECTION 1 Scope This document provides guidelines for the selection of substances for the development of test method standards. The substances and substance groups listed in the IEC 62474 database are the primary source of candidate substances. Other substances that are

40、under regulatory roadmap and market requirements can also be considered for this filtering and selection process. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references

41、, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 62474:2012, Material declaration for products of and for the electrotechnical industry 3 Terms, definitions and abbreviated terms 3.1 Terms and definitions

42、No terms and definitions are listed in this document. ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.2 Abbreviated terms

43、 CMR carcinogenic, mutagenic or toxic to reproduction CoRAP community rolling action plan EEE electrical and electronic equipment REACH registration, evaluation, authorization and restriction of chemicals RoHS restriction of hazardous substances SDO standards development organization SIN substitute

44、it now SVHC substances of very high concern 4 Process flow Substances that are contained in the IEC 62474 database have undergone technical scrutiny to determine applicability to electrotechnical products. This vetting process provides an effective first screen to narrow down the potential number of

45、 substances that may be considered for test method development within IEC. Specifically, these substances have been evaluated by technical experts to be used in electrical and electronic equipment (EEE) products. This type of assessment will need to be performed for substances that are not PD IEC/TR

46、 62936:2016IEC TR 62936:2016 IEC 2016 7 contained in the IEC 62474 database. A conceptual flow for the general substance selection decision making process is given in Figure 1. Figure 1 Substance selection process Initial list of candidate substances IEC 62321 (all parts)2 Develop screening method a

47、nd/or quantitative analysis IEC Existence of other related standards? Applicable to electrotechnical products? Done or liaise with SDO Pass No Yes Yes No Low priority: hold for future consideration Substance filtering process Fail Final substance selection Pass Fail Is the substance expected to be p

48、resent in EEE products? Yes Do not consider Done No PD IEC/TR 62936:2016 8 IEC TR 62936:2016 IEC 2016 5 Process flow steps 5.1 Chemical substance list Substances under consideration for test method development are found in the IEC 62474 materials declaration database and other readily available sour

49、ces. The IEC 62474 database is generally the initial source of information since it provides a vetted and frequently updated list of substances that is under scrutiny by either having regulatory obligations associated with them or potentially will be in the future. Given the large number of substances either being regulated or under consideration for regulation, this database provides an effective screening of substances present in electrotechnical products. The IEC 62