IEC TS 62844-2016 Guidelines for quality and risk assessment for nano-enabled electrotechnical products《纳米电工产品质量和风险评定指南》.pdf

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1、 IEC TS 62844 Edition 1.0 2016-12 TECHNICAL SPECIFICATION Guidelines for quality and risk assessment for nano-enabled electrotechnical products IEC TS 62844:2016-12(en) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2016 IEC, Geneva, Switzerland All rights reserved. Unless otherwise

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10、If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC TS 62844 Edition 1.0 2016-12 TECHNICAL SPECIFICATION Guidelines for quality and risk assessment for nano-enabled electrotechnical products INTERNATIONAL ELE

11、CTROTECHNICAL COMMISSION ICS 07.120 ISBN 978-2-8322-3712-0 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colour inside 2 IEC TS 62844:2016 IEC 2016 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 S

12、cope 7 2 Normative references 7 3 Terms, definitions and abbreviated terms 7 3.1 Terms and definitions 7 3.2 Abbreviated terms . 9 4 Quality, and risk assessment . 9 4.1 General requirement . 9 4.2 Assessment model 10 4.2.1 General . 10 4.2.2 Customer and business results 11 4.2.3 Technology measure

13、s 12 4.2.4 Measurement indicators and inter-relation between indicators . 12 4.3 Analysis methods 13 5 General quality and risk assessment requirements for NE products . 13 5.1 General . 13 5.2 Conditions for application to NE products 13 5.3 Risk management process for NE products . 14 5.4 Essentia

14、l performance 14 5.5 Expected service life . 14 5.6 Safety for NE products 14 5.7 NE product parts that contact person 14 5.8 Components of NE products . 14 5.9 General test requirement 14 6 Special assessment requirements for NE products 14 6.1 Nanomaterials environment, health and safety (EHS) con

15、trol 14 6.2 General quality control 15 6.3 General risk control . 15 Annex A (informative) General approach and rationale 16 Annex B (normative) General guidance for stakeholders declaration . 17 Annex C (informative) General guidance for correlative indicators determination . 18 C.1 General . 18 C.

16、2 Routine method 18 C.3 House of Quality (HOQ) 18 Annex D (informative) Steps for manufacture to make the stakeholders declaration 21 D.1 Standards requirements hierarchy for nano-products assessment . 21 D.2 Simplified flow for making stakeholders declaration 21 D.3 Flowchart of steps for the manuf

17、acturers to compile the stakeholders declaration 21 Bibliography 23 Figure 1 The broader standard context of conceptual model governing a nanomedical device 10 Figure 2 Performance reference model (PRM) structure . 10 Figure 3 PRM framework . 11 IEC TS 62844:2016 IEC 2016 3 Figure 4 Measurement grou

18、ps for measurement categories . 11 Figure C.1 HOQ matrix structures 19 Figure C.2 Cascaded HOQ 20 Figure C.3 HOQ structure based on the proposed PRM model . 20 Figure D.1 Standards requirements hierarchy for nano-products assessment. 21 Figure D.2 Simplified flow for compiling the stakeholders decla

19、ration 21 Figure D.3 Flowchart to compile the stakeholders declaration . 22 Table 1 The relation between measurement indicators of customer and business results and technology indicators 13 Table A.1 Rationale related to specific clauses in this document 16 Table B.1 Special requirements declaration

20、 form for the CNT-coated touch panel 17 Table C.1 Indicators relation example for CNT . 18 4 IEC TS 62844:2016 IEC 2016 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ GUIDELINES FOR QUALITY AND RISK ASSESSMENT FOR NANO-ENABLED ELECTROTECHNICAL PRODUCTS FOREWORD 1) The International Electrotechnical Com

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33、al Standard. Technical Specifications are subject to review within three years of publication to decide whether they can be transformed into International Standards. IEC TS 62844, which is a Technical Specification, has been prepared by IEC technical committee 113: Nanotechnology for electrotechnica

34、l products and systems. IEC TS 62844:2016 IEC 2016 5 The text of this Technical Specification is based on the following documents: Enquiry draft Report on voting 113/227/DTS 113/343/RVC Full information on the voting for the approval of this Technical Specification can be found in the report on voti

35、ng indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data

36、related to the specific publication. At this date, the publication will be transformed into an International Standard, reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. IMPORTANT The colour inside logo on the cov

37、er page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer. 6 IEC TS 62844:2016 IEC 2016 INTRODUCTION The nanoindustry is dealing with highly innovat

38、ive technologies and products. For the purposes of assuring their performance and assessing the risks, a reliable quality, environmental, occupational health and safety management system for nanoindustrial companies and consumers is needed. The monitoring and measuring of all relevant parameters of

39、nanomaterials and consequently identifying nonconformities in the products containing them and associated hazards are not straightforward. A systematic and practical assessment methodology for its implementation in industrial mass production is needed to simplify the monitoring processes and ensure

40、both the quality of the products and the conformance of the products to health, occupational and environmental standards. Quality needs to be defined firstly in terms of parameters or characteristics, relevant for the application, which vary from product to product. However, it is not trivial to ide

41、ntify the relevant characteristics and effectively apply these parameters for the application. The same is true for the identification of environmental and health and safety aspects, as demanded, for example, by ISO 14001 1 1for environmental aspects. This document uses a reference model to provide

42、a high level frame work, but not any details of EHS management aspects, for the identification and development of the stakeholders needs, from the relationship of inputs such as technology measures, to outputs such as customer and business results. It is intended as a nanotechnology management guide

43、line, not for details of EHS practices. However, it encourages users to adopt the necessary known EHS practices, and consider special requirements for nanotechnology. It also facilitates communication among all stakeholders. Further, it can be used to develop more specialized standards to support sp

44、ecific scenarios. The goal of this document is to specify general considerations and requirements for the assessment of quality and risk associated with nano- enabled electrotechnical products and serve as the basis for developing particular product specific standards. _ 1Numbers in square brackets

45、refer to the Bibliography. IEC TS 62844:2016 IEC 2016 7 GUIDELINES FOR QUALITY AND RISK ASSESSMENT FOR NANO-ENABLED ELECTROTECHNICAL PRODUCTS 1 Scope This document provides a recommended methodology for identifying relevant parameters of nanomaterials as well as providing generic guidelines on imple

46、mentation of quality assessment and environment/health/safety assessment for nano-enabled/nano-enhanced electrotechnical products. 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

47、 dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 31000:2009, Risk management Principles and guidelines on implementation 3 Terms, definitions and abbreviated terms 3.1 Terms and definition

48、s For the purposes of this document, the following terms and definitions apply. 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

49、/obp 3.1.1 nanoscale length range from approximately 1 nm to 100 nm SOURCE: ISO/TS 80004-1:2015 2, 2.1 3.1.2 nanomaterial material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale SOURCE: ISO/TS 80004-1:2015, 2.4 3.1.3 nano-object material with one, two or three external dimensions in the nanoscale SOURCE: ISO/TS 27687:2008 7, 2.2 8 IEC TS 62844:2016 IEC 2016 3.1.4 nanostructured m