ISO/TS 13329

ISO/TSDTS 13329:202(X)
ISO/TC 229/WG 3
Secretariat: BSI
Date: 2023-02-072024-06-04
Nanomaterials – — Preparation of safety data sheets (SDS)
Nanomatériaux — Préparation des fiches de données de sécurité (FDS)

DTS stage
© ISO #### – All rights reserved

ISO/TSDTS 13329:202X:(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO #### 2024 – All rights reserved
ii
ISO/TSDTS 13329:202(X:(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 SDS preparation . 5
4.1 General . 5
4.2 Content and general layout of an SDS . 6
4.2.1 Chemical product and company identification . 6
4.2.2 Hazard identification . 6
4.2.3 Composition of ingredients and related information . 7
4.2.4 First-aid measures . 7
4.2.5 Fire-fighting measures . 8
4.2.6 Accidental release measures . 8
4.2.7 Handling and storage . 9
4.2.8 Exposure controls and personal protection . 10
4.2.9 Physical and chemical properties . 11
4.2.10 Stability and reactivity . 12
4.2.11 Toxicological information . 12
4.2.12 Ecological information . 13
4.2.13 Disposal considerations . 13
4.2.14 Transportation information . 14
4.2.15 Regulatory information . 14
4.2.16 Other information . 14
5 Cut-off values and concentration limits . 14
Annex A (informative) Example measurement methods and standards (ISO/TR 13014) . 16
Bibliography . 25

© ISO #### 2024 – All rights reserved
iii
ISO/TSDTS 13329:202X:(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documentsdocument should be noted. This document was drafted in accordance with the editorial rules
of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Field Code Changed
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of this
document, ISO had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may be
obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for
identifying any or all such patent rights. Details of any patent rights identified during the development of the
document will be in the Introduction and/or on the ISO list of patent declarations received (see
www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee 229 Nanotechnologies.
This second edition cancels and replaces the first edition (ISO/TR 13329:2012), which has been technically
revised.
The main changes arechange is as follows:
— — The document has been changed to a Technical Specification.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
Field Code Changed
iv © ISO #### 2024 – All rights reserved
iv
ISO/TSDTS 13329:202(X:(en)
Introduction
This Technical Specification provides guidance on the development of safety data sheets (SDSs) for
manufactured nanomaterials (and materials or products that contain manufactured nanomaterials) and
provides additional information on safety issues associated with manufactured nanomaterials. (Manufactured
nanomaterials are defined as materials that are intentionally produced materials to have specific properties
or a specific composition and which have any external dimension in the nanoscale or internal structure or
surface structure in the nanoscale). It . This document is not a stand-alone document and should be used in
[1]
conjunction with ISO 11014:2009[1]. This Technical Specification considers. This document takes into
account the Globally harmonized system of classification and labelling of chemicals (GHS) document on hazard
communication:, i.e. safety data sheets. The GHS was developed by the United Nations and is being
incorporated into the laws of various regions and nations, many of which already have laws that govern the
preparation of SDSs.
Currently, there is limited information on the possible hazards of some nanomaterials. In some cases, the
degree of risk to workers or others who can be exposed to nanomaterials is partly unknown, as the possible
toxicological effects of nanomaterials are not yet well known and exposure is difficult to measure. Most hazard
information and communication approaches requirenecessitate preparation of aan SDS for hazardous
chemicals, including those containing nanomaterials, for use in manufacture, storage, transport or other
occupational handling activities. Yet, only a few SDSs contain specific information about nanomaterials or are
specific to nanomaterials. Those that exist generally provide insufficient hazard information (see
Reference [2]).[2]). There is evidence that some nanomaterials can be more hazardous, e.g. more bio-reactive
or active, leading to higher toxicity, than the same material in bulk (non-nanoscale) form. Characteristics
predictive of potential safety issues or toxicity for manufactured nanomaterials need to be determined and
included in the preparation of aan SDS. Within the European Union and the UK, the legislation that addresses
industrial substances including nanomaterials requiresspecifies that hazardous substances and mixtures are
accompanied by aan SDS when placed on the market.
The most fundamental ethical responsibility faced by manufacturers is to make users aware that
nanomaterials have been added to a product and to transmitcommunicate, in aan SDS, the hazards the product
can present and the most effective ways to mitigate those hazards, relying on the hierarchy of controls, which.
The hierarchy of controls is a method that is found in nearly every international guidance document on
responsible management of nanomaterials. This Technical Specificationdocument considers the
precautionary approach in terms of toxicity and other risks associated with nanomaterials and thus. It
recommends providing aan SDS for nanomaterials and nanomaterial-containing products, regardless of
whether or not the material is classified as hazardous, unless there are existing data for the nanomaterial
which demonstrates that it is non-hazardous, or if it is not envisaged that they can be released as nano-objects,
or their agglomerates and aggregates greater than 100 nm (NOAA), during handling or use.
© ISO #### 2024 – All rights reserved
v
ISO/DTS 13329:(en)
Nanomaterials – — Preparation of safety data sheets (SDS)
1 Scope
This document provides guidance on the development of content for, and consistency in, the communication
of information on safety, health and environmental matters in safety data sheets (SDS) for substances
classified as manufactured nanomaterials. (and materials or products that contain manufactured
nanomaterials). It provides additional information on safety issues associated with manufactured
[1]
nanomaterials. It provides supplemental guidance to ISO 11014:2009[1] on the preparation of SDSs.
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, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO/FDIS 80004-1, Nanotechnologies – Vocabulary – Part 1: Core vocabulary
Globally harmonized system of classification and labelling of chemicals (GHS). United Nations Economic
Commission for Europe, Fourth Edition, 2011
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/FDIS 80004-1, GHS :2011 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
Field Code Changed
— IEC Electropedia: available at https://www.electropedia.org/https://www.electropedia.org/
3.1
agglomerate
collection of weakly bound particles or aggregates or mixtures of the two where the resulting external surface
area is similar to the sum of the surface areas of the individual components
Note 1 to entry: The forces holding an agglomerate together are weak forces, for example van der Waals forces, or simple
physical entanglement.
Note 2 to entry: Agglomerates are also termed secondary particles and the original source particles are termed primary
particles.
[SOURCE: ISO 80004-1:2023, 3.2.4]
3.2
aggregate
particle comprising strongly bonded or fused particles where the resulting external surface area is
significantly smaller than the sum of surface areas of the individual components
Note 1 to entry: The forces holding an aggregate together are strong forces, for example covalent bonds, or those
resulting from sintering or complex physical entanglement.
Note 2 to entry: Aggregates are also termed secondary particles and the original source particles are termed primary
particles.
© ISO #### 2024 – All rights reserved
ISO/DTS 13329:(en)
[SOURCE: ISO/FDIS 80004-1:2023, 3.2.5]
3.3
bioaccumulation
process of accumulation of a substance in organisms or parts thereof
[SOURCE: ISO 6107-6:2004, definition 10:2021, 3.64]
3.4
biodu
...