ISO/TS 13329:2024
(Main)Nanomaterials — Preparation of safety data sheets (SDS)
Nanomaterials — Preparation of safety data sheets (SDS)
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 nanomaterials. It provides supplemental guidance to ISO 11014 on the preparation of SDSs.
Nanomatériaux — Préparation des fiches de données de sécurité (FDS)
L'ISO/TR 13329:2012 donne des lignes directrices pour fournir des informations cohérentes sur la sécurité, la santé et l'environnement dans des fiches de données de sécurité (FDS) concernant des substances classées en tant que nanomatériaux manufacturés et des produits chimiques contenant des nanomatériaux manufacturés. Il fournit des lignes directrices complémentaires de l'ISO 11014:2009 sur la préparation des FDS en général, en traitant la préparation d'une fiche de données de sécurité (FDS) à la fois pour un (des) nanomatériau(x) manufacturé(s) avec des matériaux et des mélanges contenant des nanomatériaux manufacturés.
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Standards Content (Sample)
Technical
Specification
ISO/TS 13329
Second edition
Nanomaterials — Preparation of
2024-09
safety data sheets (SDS)
Nanomatériaux — Préparation des fiches de données de
sécurité (FDS)
Reference number
© ISO 2024
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ii
Contents Page
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 .6
4.2.4 First-aid measures .7
4.2.5 Fire-fighting measures .7
4.2.6 Accidental release measures .7
4.2.7 Handling and storage .8
4.2.8 Exposure controls and personal protection .10
4.2.9 Physical and chemical properties .10
4.2.10 Stability and reactivity .11
4.2.11 Toxicological information .11
4.2.12 Ecological information . 12
4.2.13 Disposal considerations . 12
4.2.14 Transportation information . 13
4.2.15 Regulatory information . 13
4.2.16 Other information . 13
5 Cut-off values and concentration limits .13
Annex A (informative) Example measurement methods and standards (ISO/TR 13014) .15
Bibliography .21
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use 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.
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.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 change 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.
iv
Introduction
Manufactured nanomaterials are defined as materials that are intentionally produced 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. This document is not a stand-alone document and should
[1]
be used in conjunction with ISO 11014. 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 necessitate preparation of an 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]). 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 an SDS. Within the European Union and the UK, the legislation that addresses
industrial substances including nanomaterials specifies that hazardous substances and mixtures are
accompanied by an 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 communicate, in an SDS, the hazards the product
can present and the most effective ways to mitigate those hazards, relying on the hierarchy of controls.
The hierarchy of controls is a method that is found in nearly every international guidance document on
responsible management of nanomaterials. This document considers the precautionary approach in terms of
toxicity and other risks associated with nanomaterials. It recommends providing an 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.
v
Technical Specification ISO/TS 13329:2024(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 nanomaterials. It provides
[1]
supplemental guidance to ISO 11014 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 80004-1, Nanotechnologies – Vocabulary — Part 1: Core vocabulary
Globally harmonized system of classification and labelling of chemicals (GHS). United Nations Economic
Commission for Europe, Tenth revised edition, 2023
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80004-1, GHS 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
— IEC Electropedia: available at 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.
[SOURCE: ISO 80004-1:202
...
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