ISO/DTS 12901-2

ISO/TC 229/WG 3
Secretariat: BSI
Date: 2025-03-04
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2:
Use of the control banding approach
Nanotechnologies — Gestion du risque professionnel appliquée aux nanomatériaux manufacturés — —
Partie 2: Utilisation de l'approche par bandes de dangers

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ii
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 1
5 General framework for control banding . 2
5.1 General . 2
5.2 Information gathering and data recording . 3
5.3 Hazard banding . 3
5.4 Exposure banding . 4
5.5 Control banding . 4
5.6 Review and data recording . 4
6 Information gathering . 5
6.1 Characterization . 5
6.2 Exposure characterization . 7
6.3 Characterization of control measures . 8
7 Control banding implementation . 8
7.1 Preliminary remarks . 8
7.2 Hazard band setting . 9
7.3 Exposure band setting . 16
7.4 Control band setting and control strategies . 22
7.5 Evaluation of controls . 23
7.6 Retroactive approach — Risk banding . 25
8 Performance, review and continual improvement . 27
8.1 General . 27
8.2 Objectives and performance . 27
8.3 Data recording . 28
8.4 Management review . 28
Annex A (informative) Health hazard class according to GHS . 29
Annex B (informative) Nanomaterial risk assessment (NaRA) . 30
Annex C (Informative) Modified occupational hazard band (OHB) . 33
Bibliography . 37

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
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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).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
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The committee responsible for this This document iswas prepared by Technical Committee ISO/TC 229,
Nanotechnologies.
This second edition cancels and replaces the first edition (ISO/TS 12901-2:20122014) which has been
technically revised.
The main changes are as follows:
— revision of examples in the annexes, including The Control Banding Nano Tools NaRA, GoodNanoGuide
and OHB were added as examples in the annexes. The Stoffenmanager Tool was removed as an annex, and
replacement of Annex Badded as a reference.;
- Websites that no longer are working were removed
— Additionalrevision of links to websites;
— addition of sources for sullall NOAA hazard characterization inventories were added DANA 4.0 and OECD.
ISO/TS 12901 consists of the following parts, under the general title Nanotechnologies— Occupational risk
management applied to engineered nanomaterials:
— — Part 1: Principles and approaches
— Part 2: Use of the control banding approach
iv
A list of all parts in the ISO/TS 12901 series can be found on the ISO website.
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.
v
Introduction
According to the current state of knowledge, nanoNano-objects, and their aggregates and agglomerates
greater than 100 nm (NOAA)), can exhibit properties, including toxicological properties, which are different
from those of non-nanoscale (bulk) material. Therefore, current occupational exposure limits (OELs), which
are mostly established for bulk materials can be inappropriate for NOAA. In the absence of relevant regulatory
specifications for NOAA, theThe control banding approach can be used as a first approach to controlling
workplace exposure to NOAA.
NOTE: Regulatory specifications can apply regarding NOAA.
Control banding is a pragmatic approach which can be used for the control of workplace exposure to possibly
hazardous agents with unknown or uncertain toxicological properties and for which quantitative exposure
estimations are lacking. The ultimate purpose of control banding is to control exposure to prevent any possible
adverse effects on workers’ health. It can complement the traditional quantitative methods based on air
sampling and analysis with reference to OELs when they exist. It can provide an alternative risk assessment
and risk management process, by grouping occupational settings in categories presenting similarities of either
hazards and/or exposure, or both, while incorporating professional judgment and monitoring. This process
applies a range of control techniques (such as general ventilation or containment) to a specific chemical,
considering its range (or band) of hazard and the range (or band) of exposure.
In general, control banding is based on the idea that while workers can be exposed to a diversity of chemicals,
implying a diversity in risks, the number of common approaches to risk control is limited. These approaches
are grouped into levels based on how much protection the approach offers (with “stringent” controls being
the most protective). The greater the potential for harm, the greater the levels of protection needed for
exposure control.
Control banding was originally developed by the pharmaceutical industry as a way to safely work with new
chemicals that had little or no toxicity information. These new chemicals were classified into “bands” based
on the toxicity of analogous and better-known chemicals and were linked to anticipated safe work practices,
[1 [1]]
taking into consideration exposure assessments. Each band was then aligned with a control scheme. .
Following this concept, the Health and Safety Executive (HSE) in the UK has developed a user-friendly scheme
[2 [2]]
called COSHH Essentials , , primarily for the benefit of small- and medium-sized enterprises that potentially
do not benefit from the expertise of a resident occupational hygienist. The Department of Occupational Safety
and Health Malaysia published the Nanomaterial Risk Assessment (NaRA) based on Reference [2COSHHs
[3]
Essential and GoodNanoGuide (see details in Annex B).]. Similar schemes are used in the practical guidance
[4 [4]] [5]
given by the German Federal Institute for Occupational Safety and Health. . The Stoffenmanager Tool ®
1) [5 ]
tool represents a further development, , combining a hazard banding scheme similar to that of COSHH
Essentials and an exposure banding scheme based on an exposure process model, which was customized to
allow non-expert users to understand and use the model.
Control banding applies to issues related to occupational health in the development, manufacturing and use
of NOAA under normal or reasonably predictable conditions, including maintenance and cleaning operations
but excluding incidental or accidental situations.
Control banding is not intended to apply to the fields of safety management, environment or transportation;
it is considered as only one part of a comprehensive risk management process.

1)
The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
vi
Control banding can be particularly useful for the risk assessment and management of nanomaterials, given
the level of uncertainty in work-related potential health risks from NOAA. It maycan be used for risk
management in a proactive manner and in a retroactive manner. In the proactive manner existing control
measures,
...