IEC TS 62844:2016
(Main)Guidelines for quality and risk assessment for nano-enabled electrotechnical products
Guidelines for quality and risk assessment for nano-enabled electrotechnical products
IEC TS 62844:2016(E) provides a recommended methodology for identifying relevant parameters of nanomaterials as well as providing generic guidelines on implementation of quality assessment and environment/health/safety assessment for nano-enabled/nano-enhanced electrotechnical products.
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Standards Content (Sample)
IEC TS 62844 ®
Edition 1.0 2016-12
TECHNICAL
SPECIFICATION
colour
inside
Guidelines for quality and risk assessment for nano-enabled electrotechnical
products
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IEC TS 62844 ®
Edition 1.0 2016-12
TECHNICAL
SPECIFICATION
colour
inside
Guidelines for quality and risk assessment for nano-enabled electrotechnical
products
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 07.120 ISBN 978-2-8322-3712-0
– 2 – IEC TS 62844:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 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 measures . 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 Essential 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) control . 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 stakeholder’s declaration . 17
Annex C (informative) General guidance for correlative indicators determination . 18
C.1 General . 18
C.2 Routine method . 18
C.3 House of Quality (HOQ) . 18
Annex D (informative) Steps for manufacture to make the stakeholder’s declaration . 21
D.1 Standards requirements hierarchy for nano-products assessment . 21
D.2 Simplified flow for making stakeholder’s declaration . 21
D.3 Flowchart of steps for the manufacturers to compile the stakeholder’s
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
Figure 4 – Measurement groups 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 stakeholder’s declaration . 21
Figure D.3 – Flowchart to compile the stakeholder’s 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 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
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IEC TS 62844, which is a Technical Specification, has been prepared by IEC technical
committee 113: Nanotechnology for electrotechnical products and systems.
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 r
...
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