Nanomanufacturing - Product specifications - Part 1: Basic concepts

IEC TS 62565-1:2023 which is a Technical Specification, defines the system of blank detail specifications for nanomaterials and nano-assemblies as well as final nano-enabled products addressed in the nanomanufacturing value chain.
It defines the concepts of blank detail specification (BDS), detail specification (DS) and key control characteristic (KCC). Furthermore, it provides guidelines how to develop and use product specifications, particularly the IEC 62565 series, in the field of nanotechnology.
This document also provides guidelines regarding the certification and reliability aspects for products specified by a DS and associated KCCs.
NOTE 1 The IEC 62565 series uses an open generic structure that can be flexibly adapted to technical developments. The double indexing of the individual parts allows grouping into technology areas without restriction due to an overly strict hierarchical structure.
NOTE 2 Key elements of the IEC 62565 series are a consensus-based set of key control characteristics (KCCs) with clear definitions and standardized measurement procedures to measure them.

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IEC TS 62565-1:2023 - Nanomanufacturing - Product specifications - Part 1: Basic concepts Released:5/11/2023
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IEC TS 62565-1 ®
Edition 1.0 2023-05
Nanomanufacturing – Product specifications –
Part 1: Basic concepts
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IEC TS 62565-1 ®
Edition 1.0 2023-05
Nanomanufacturing – Product specifications –

Part 1: Basic concepts
ICS 07.120 ISBN 978-2-8322-7020-2

– 2 – IEC TS 62565-1:2023  IEC 2023
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 General . 12
4.1 Requirements for product specifications . 12
4.2 Generic systematics of specifications for nanomaterials and nano-enabled
products . 12
4.3 Blank detail specification . 13
4.4 Detail specification . 14
5 Structure of a blank detail specification . 15
5.1 General . 15
5.2 General product description and procurement information . 15
5.3 Specification of key control characteristics . 16
6 Measurement procedures for key control characteristics . 17
6.1 General . 17
6.2 SML 4: Standardized measurement procedure for the KCC available . 17
6.3 SML 3: Adoption and adaptation of an existing standardized measurement
procedure . 17
6.4 SML 2: Guidance for measurement procedures in the absence of a standard . 17
6.5 SML 1: No documented measurement procedure available . 18
6.6 Overview of measurement methods and SML of the related measurement
procedures . 18
7 Certification aspects . 19
7.1 General remarks . 19
7.2 Product audit . 20
7.3 Factory audit . 20
8 Process steps for the development of nanomaterial or nano-enabled product detail
specification . 20
8.1 General . 20
8.2 Defining the scope of the specification . 20
8.3 Defining the list of key control characteristics. 21
Annex A (informative) Structure of standards for blank detail specifications . 22
A.1 Title and scope of standards for blank detail specifications . 22
A.1.1 Generic format of the title . 22
A.1.2 Generic format of the scope . 22
A.2 Content of standards for blank detail specifications . 22
Annex B (informative) Structure of measurement standards for key control
characteristics . 24
B.1 Title and scope of measurement standards for key control characteristics. 24
B.1.1 Generic format of the title . 24
B.1.2 Generic format of the scope . 24
B.2 Content of measurement standards for key control characteristics . 24
Annex C (informative) Guidance of quality evaluation and reliability assessment . 26
C.1 General . 26
C.2 Content of quality and reliability assessment standard . 26

C.3 QM system audit . 27
C.4 Process audit . 27
C.5 Product audit . 27
C.6 Audit score . 27
C.7 Audit frequency . 28
C.8 Environmental, health and safety (EHS) aspects . 28
Bibliography . 29

Figure 1 – Systematics of IEC TC 113 standards . 6
Figure 2 – KCCs and their relation to the BDS: general scheme . 14
Figure 3 – KCCs and their relation to the BDS: example . 14

Table 1 – General product description and procurement information . 15
Table 2 – Format for specification of key control characteristics . 16
Table 3 – Overview of measurement methods (Example) . 19

– 4 – IEC TS 62565-1:2023  IEC 2023
Part 1: Basic concepts
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IEC TS 62565-1 has been prepared by IEC technical committee 113: Nanotechnology for
electrotechnical products and systems. It is a Technical Specification.
The text of this Technical Specification is based on the following documents:
Draft Report on voting
113/697/DTS 113/723/RVDTS
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Technical Specification is English.

This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at The main document types developed by IEC are
described in greater detail at
A list of all parts in the IEC 62565 series, published under the general title Nanomanufacturing –
Product specifications, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under web

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