IEC TS 62565-1:2023

IEC TS 62565-1
®

Edition 1.0 2023-05
TECHNICAL
SPECIFICATION

colour
inside


Nanomanufacturing – Product specifications –
Part 1: Basic concepts
IEC TS 62565-1:2023-05(en)

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IEC TS 62565-1

®


Edition 1.0 2023-05




TECHNICAL



SPECIFICATION








colour

inside










Nanomanufacturing – Product specifications –

Part 1: Basic concepts


























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ELECTROTECHNICAL


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ICS 07.120 ISBN 978-2-8322-7020-2




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– 2 – IEC TS 62565-1:2023  IEC 2023
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
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

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IEC TS 62565-1:2023  IEC 2023 – 3 –
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

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– 4 – IEC TS 62565-1:2023  IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

NANOMANUFACTURING –
PRODUCT SPECIFICATIONS –

Part 1: Basic concepts

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
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,
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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
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Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
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consensus of opinion on the relevant subjects since each technical committee has representation from all
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
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.

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IEC TS 62565-1:2023  IEC 2023 – 5 –
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 www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
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 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.

IMPORTANT – The "colour inside" logo on the cover page of this document 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.

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– 6 – IEC TS 62565-1:2023  IEC 2023
INTRODUCTION
The mission of IEC technical committee 113 (IEC TC 113) is to develop IEC publications based
on quality management (QM) principles in order to facilitate the transition of nano-enabled
products from development to mass production.
The standardization strategy of IEC TC 113 covers the entire value chain from the production
of nanomaterials and their use as independent products (in other words, the product is the raw
material) to their use as raw materials for integration into subassemblies or end-user products.
Since IEC TC 113 is an electrotechnical committee, the focus of standardization is on
electrotechnical products without excluding the applicability to non-electrotechnical products.
The development of IEC Publications for reliability and durability assessment is also in the
scope of IEC TC 113.
This part of IEC 62565 provides the basic concept and guidelines on how to write the various
types of blank detail specification (BDS) and detail specification (DS) in a standardized and
harmonized manner and describes the systematics behind these documents.
The systematics is based on the "three pillar concept" and provides:
– standards for the specification of nanomaterials and nano-enabled products (left pillar:
IEC TS 62565-x-y);
– standards for the measurement of key control characteristics (KCCs) for nanomaterials and
nano-enabled products (right pillar: IEC TS 62607-x-y);
– standards for quality and reliability assessment. These include test methods for reliability
and durability, but also general standards based on existing International Standards for
quality management systems (QMS) adapted to the specific needs of nanotechnology
(centre pillar: IEC TS 62876-x-y).
Blank detail specifications (BDSs)
provide a list of all known product
performance parameters, called key
control characteristics (KCCs), of
the nanomaterial or nano-
subassembly which is part of the
nano value chain.
Detail specifications (DSs) provide
values and attributes (that had been
left blank in BDS) for a specific
application agreed between supplier
and customer.
KCC measurement standards
provide a detailed description how to
measure a specific KCC and report
the results. There can be several
measurement methods for the same
KCC, which can be selected based
on the needs of the application.
Quality and reliability assessment
standards describe the quality and
reliability of nano-enabled products.


Figure 1 – Systematics of IEC TC 113 standards
In Figure 1, the logical connections in this comprehensive system of quality assurance for
nanomaterials and nano-enabled products are visualized. Due to the interdependence of the
three types of standards, it is important that standardization in IEC TC 113 covers all three
columns in order to arrive at a consistent system of standards which can be operated in a
"seamless" fashion.

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IEC TS 62565-1:2023  IEC 2023 – 7 –
This part of IEC 62565 provides the basic concept for the series of BDSs. Examples of other
parts addressing specific technology areas are:
– IEC TS 62565-2-x: Carbon nanotube materials
– IEC TS 62565-3-x: Graphene-based materials
– IEC TS 62565-4-x: Luminescent nanomaterials
– IEC TS 62565-5-x: Nano-enabled energy storage materials
NOTE It is expected that additional BDS series will emerge as industrial uptakes of new materials or new
applications occur.
An indispensable basis of the concept of BDS and DS are clear definitions of the product
characteristics and detailed descriptions for measuring these characteristics. These
characteristics are called key control characteristics (KCCs) because they represent key
features of the products to be monitored in the framework of a quality management system.
IEC 62607 consists of a series of KCC measurement Technical Specifications to be used for
the BDS and DS:
– IEC TS 62607-2-x: KCCs for carbon nanotube materials
– IEC TS 62607-3-x: KCCs for luminescent nanomaterials
– IEC TS 62607-4-x: KCCs for nano-enabled electrical energy storage
– IEC TS 62607-5-x: KCCs for thin-film organic/nano electronic devices
– IEC TS 62607-6-x: KCCs for graphene-based material
– IEC TS 62607-7-x: KCCs for nano-enabled photovoltaics
– IEC TS 62607-8-x: KCCs for nano-enabled metal-oxide interfacial devices
– IEC TS 62607-9-x: KCCs for nano-scale stray magnetic field measurements
Each part of the IEC 62607 series of measurement Technical Specifications describes exactly
one method for measuring a particular KCC. Measurement standards outside the IEC 62607
series can be used in IEC 62565 BDSs and DSs if their applications are clear in the context of
the specification.
In addition to the specification of the nanomaterial characteristics (IEC 62565 series) and the
standardized procedures for the measurement of the characteristics (IEC 62607 series), two
additional aspects of quality management are relevant for complete quality assurance:
The performance of materials and products at the time of manufacture is one thing, but the
reliability is an additional relevant quality assurance metric. Two examples in the IEC 62876
series are given below.
• IEC TS 62876-2-1:2018, Nanotechnology – Reliability assessment – Part 2-1: Nano-
enabled photovoltaic devices – Stability test
• IEC TS 62876-3-1:2022, Nanomanufacturing – Reliability assessment – Part 3-1:
Graphene-based material – Stability: Temperature and humidity test
To ensure that the sourcing of the nanomaterials and the manufacturing process are
consistently managed according to the prescriptions of ISO 9001:2015, the first steps have
been taken in the development of an IEC standard for a quality management system in
nanoelectronics.
The reliability standards and the quality management system standard are represented by the
centre pillar in Figure 1.
More background information can be found in Annex C.

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NANOMANUFACTURING –
PRODUCT SPECIFICATIONS –

Part 1: Basic concepts



1 Scope
This part of IEC 62565, 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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
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/obp
3.1
key control characteristic
KCC
product characteristic which can affect safety or compliance with regulations, fit, function,
performance, quality, reliability or subsequent processing of the final product
Note 1 to entry: The measurement of a key control characteristic is described in a standardized measurement
procedure with known accuracy and precision.
Note 2 to entry: It is possible to define more than one measurement method for a key control characteristic if the
correlation of the results is well-defined and known (3.2).

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IEC TS 62565-1:2023  IEC 2023 – 9 –
3.2
blank detail specification
BDS
structured generic specification providing a comprehensive set of key control characteristics
which are needed to describe a specific product without assigning specific values or attributes
Note 1 to entry: Examples of nano-enabled products are: nanocomposites and nano-subassemblies.
Note 2 to entry: Blank detail specifications are intended to be used by industrial users to prepare their detail
specifications used in bilateral procurement contracts. A blank detail specification facilitates the comparison and
benchmarking of different materials. Furthermore, a standardized format makes procurement more efficient and more
error robust.
3.3
detail specification
DS
specification based on a blank detail specification with assigned values and attributes
Note 1 to entry: The characteristics listed in the detail specification are usually a subset of the key control
characteristics listed in the relevant blank detail specification. The industrial partners define only those
characteristics which are required for the intended application.
Note 2 to entry: Detail specifications are defined by the industrial partners. Standards development organizations
will be involved only if there is a general need for a detail specification in an industrial sector.
Note 3 to entry: The industrial partners may define additional key control characteristics if they are not listed in the
blank detail specification.
3.4
good practice guide
GPG
informal document which is not necessarily peer reviewed but can be used as a working
document to establish a measurement procedure
Note 1 to entry: A GPG serves as the first document based on initial scientific research which is intended to be the
first step toward future standardization.
3.5
standard maturity level
SML
measure for estimating the maturity of a measurement procedure based on the consensus
achieved in the stakeholder community
Note 1 to entry: SML 1 – No documented measurement procedure available.
Note 2 to entry: SML 2 – Good practice guide publicly available based on a reasonable consensus achieved in the
stakeholder community, e.g. an industrial or academic consortium.
Note 3 to entry: SML 3 – IEC or ISO standard or Technical Specification available which can be applied with
modification and adaption to the intended application and use case of the blank detail specification scope.
Note 4 to entry: SML 4 – IEC or ISO standard or Technical Specification available for the exact intended application
and use case of the blank detail specification.
3.6
procurement information
information other than key control characteristics needed for the procurement process
3.7
measurand
quantity intended to be measured
Note 1 to entry: If the quantity is a key control characteristic, the measurement is an essential part of the quality
management system.

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– 10 – IEC TS 62565-1:2023  IEC 2023
[SOURCE: ISO/IEC Guide 99:2007, 2.1, modified – Notes to entry and examples have been
deleted and a new Note 1 to entry has been added.]
3.8
measurement
process of experimentally obtaining one or more values that can reasonably be attributed to a
quantity
Note 1 to entry: If the quantity is a key control characteristic, the measurement is an essential part of the quality
management system.
[SOURCE: ISO/IEC Guide 99:2007, 2.1, modified – In the definition, "quantity values" has
been replaced by "values". Notes to entry have been deleted and a new Note 1 to entry has
been added.]
3.9
measurement accuracy
closeness of agreement between a measured quantity value and a true quantity value of a
measurand
Note 1 to entry: The concept ‘measurement accuracy’ is not a quantity and is not given a numerical quantity value.
A measurement is said to be more accurate when it offers a smaller measurement error.
[SOURCE: ISO/IEC Guide 99:2007, 2.13, modified – Notes 2 and 3 to entry have been
deleted.]
3.10
measurement method
process of experimentally obtaining one or more values that can reasonably be attributed to a
quantity
Note 1 to entry: If the quantity is a key control characteristic, the measurement is an essential part of the quality
management system.
3.11
measurement principle
phenomenon serving as a basis of a measurement
EXAMPLE 1 Thermoelectric effect applied to the measurement of temperature.
EXAMPLE 2 Energy absorption applied to the measurement of amount-of-substance concentration.
EXAMPLE 3 Hall effect applied to the measurement of magnetic flux density.
Note 1 to entry: The phenomenon can be of a physical, chemical, or biological nature.
[SOURCE: ISO/IEC Guide 99:2007, 2.4, modified – EXAMPLE 3 has been replaced.]
3.12
measurement procedure
detailed description of a measurement according to one or more measurement principles and
to a given measurement method, based on a measurement model and including any calculation
to obtain a measurement result
Note 1 to entry: A measurement procedure is usually documented in sufficient detail to enable an operator to
perform a measurement.
Note 2 to entry: A measurement procedure can include a statement concerning a target measurement uncertainty.
Note 3 to entry: A measurement procedure is sometimes called a standard operating procedure, abbreviated SOP.
[SOURCE: ISO/IEC Guide 99:2007, 2.6]

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IEC TS 62565-1:2023  IEC 2023 – 11 –
3.13
measurement result
set of quantity values being attributed to a measurand together with any other available relevant
information
Note 1 to entry: A measurement result is generally expressed as a single measured quantity value and a
measurement uncertainty. If the measurement uncertainty is considered to be negligible for some purpose, the
measurement result may be expressed as a single measured quantity value. In many fields, this is the common way
of expressing a measurement result.
[SOURCE: ISO/IEC Guide 99:2007, 2.9, modified – Notes 1 and 3 to entry have been deleted.]
3.14
m
...