Nanotechnologies — A test method for detection of nano-object(s) release from mask media

This TS specifies a test method for detection of nano-object/s release from respiratory masks media containing nanomaterial/s under different (light, medium and heavy) working conditions. In addition this standard also provides the sampling procedure and qualitative characterization methods of the released nano-object/s. The document does not consider the health and safety aspects of the released nanomaterials as well as their threshold limit values.

Nanotechnologies — Une méthode d'essai pour la détection de la libération de nano-objet(s) à partir de masques

General Information

Status
Not Published
Technical Committee
Current Stage
5092 - FDIS referred back to TC or SC
Due Date
07-Feb-2025
Completion Date
07-Feb-2025
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ISO/TS 11353 - Nanotechnologies — A test method for detection of nano-object(s) release from mask media Released:10/21/2024
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FINAL DRAFT
Technical
Specification
ISO/TC 229
Nanotechnologies — A test method
Secretariat: BSI
for detection of nano-object(s)
Voting begins on:
release from mask media
2024-11-04
Nanotechnologies — Une méthode d'essai pour la détection de la
Voting terminates on:
libération de nano-objet(s) à partir de masques
2024-12-30
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
Technical
Specification
ISO/TC 229
Nanotechnologies — A test method
Secretariat: BSI
for detection of nano-object(s)
Voting begins on:
release from mask media
Nanotechnologies — Une méthode d'essai pour la détection de la
Voting terminates on:
libération de nano-objet(s) à partir de masques
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviation terms . 4
5 Classification . 4
6 Test requirements . 4
6.1 Qualification of nano-object(s) in the mask media .4
6.2 Test rig characteristics .5
7 Test procedure . 7
7.1 Pre-conditioning .7
7.2 Air flow measurement .7
7.3 Sampling and monitoring of released nano-object(s) .7
7.3.1 Filter-based sampling methods .7
7.3.2 Real-time methods.8
8 Determination of qualitative properties of released nano-object(s) . 8
8.1 Measurands related to chemical measurement of nano-object(s) .8
8.1.1 General .8
8.1.2 SEM-energy dispersive X-ray spectroscopy (EDX) and wavelength-dispersive
X-ray spectroscopy (WDS) .9
8.1.3 Electron energy loss spectroscopy (EELS) .10
8.1.4 X-ray fluorescence spectroscopy (XRF) .10
8.1.5 Auger electron spectroscopy (AES) .10
8.1.6 Secondary ion mass spectroscopy (SIMS) .10
8.1.7 X-ray photoelectron spectroscopy (XPS) .11
8.2 Measurands related to size and shape measurement of nano-object(s) .11
8.2.1 General .11
8.2.2 Differential mobility analysis system (DMAS) . 12
8.2.3 Condensation particle counter (CPC) . 13
8.2.4 Transmission electron microscopy (TEM) combined with TEM grid samplers . 13
8.2.5 Scanning electron microscopy (SEM) . 13
8.2.6 Atomic force microscopy (AFM) .14
8.2.7 Single particle inductively coupled plasma–mass spectrometry (SP-ICP-MS) .14
8.2.8 Field flow fractionation (FFF) . 15
9 Reporting .15
9.1 General information. 15
9.2 Mandatory characteristics .16
Annex A (informative) Test report format for detection of nano-object(s) release from mask
media . 17
Bibliography .18

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 ISO/TC 229 Nanotechnologies.
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
Increasing air pollution and the proliferation of airborne pathogens such as coronavirus are among the
most important threats to the global environment and human health. There are three main routes for
contaminants (aerosols, bio aerosols, gases and vapours) to enter the body, including respiratory system,
dermal and ingestion. Of these routes, the respiratory system is the most important and dominant way
[1]-[3]
of entry. Therefore, protection of the respiratory system is of particular importance, justifying the
use of mask media of a high level of protection. The emergence of the coronavirus pandemic and airborne
particulate matter (PM) pollution has led to remarkably high demand for face masks and, as a result, the
market for protective face masks has significantly increased. In this regard, polymeric fibrous media have
been developed. Fibrous media containing nano-object(s), such as nanofibers and/or nanoparticles, have
shown enhanced performance in trapping ultrafine particles, microbes and viruses, at lower pressure drops
compared to previous types (mask media without nano-object(s)). Nano-object(s) can be coated on the
surface of face mask fibres or nanofibres, or can also be embedded within the polymeric fibres or nanofibres
themselves. Two major production methods for face mask fibrous media, includes the melt blowing and
electrospinning processes. Both processes involve the production of fibres or nanofibres that can serve as a
matrix where nano-object(s) can be embedded or surface-applied. Despite the above-mentioned performance
advantages, face mask media containing nano-object(s) can potentially lead to unforeseen environmental
and human health hazards due to the possible release of nano-object(s) during their life cycle. Releases of
component nano-object(s) from face masks can occur as a result of their design, manufacture, misuse or
improper handling.
Nano-object(s) can be released into different media (such as air, sweat, effluent water) during product use
[4],[5]
and care. Generally, data on the fraction of nano-object(s) release from textile materials and products,
especially into the air, is limited. Research shows
...


ISO/TC 229
Secretariat: BSI
Date: 2024-10-21
Nanotechnologies — A test method for detection of nano-object(s)
release from mask media
Nanotechnologies — Une méthode d'essai pour la détection de la libération de nano-objet(s) à partir de
masques
ISO #####-#:####(X/DTS 11353:(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
© ISO #### 2024 – All rights reserved
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviation terms . 4
5 Classification . 5
6 Test requirements . 5
6.1 Qualification of nano-object(s) in the mask media . 5
6.2 Test rig characteristics . 5
7 Test procedure . 8
7.1 Pre-conditioning . 8
7.2 Air flow measurement . 9
7.3 Sampling and monitoring of released nano-object(s) . 9
8 Determination of qualitative properties of released nano-object(s) . 9
8.1 Measurands related to chemical measurement of nano-object(s) . 9
8.2 Measurands related to size and shape measurement of nano-object(s) . 13
9 Reporting . 17
9.1 General information . 17
9.2 Mandatory characteristics . 18
Annex A (informative) Test report format for detection of nano-object(s) release from mask
media . 19
Bibliography . 21

© ISO 2024 – All rights reserved
iii
ISO #####-#:####(X/DTS 11353:(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).
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.
Field Code Changed
This document was prepared by Technical Committee ISO/TC 229 Nanotechnologies.
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.
© ISO #### 2024 – All rights reserved
iv
Introduction
Increasing air pollution and the proliferation of airborne pathogens such as coronavirus are among the most
important threats to the global environment and human health. There are three main routes for contaminants
(aerosols, bio aerosols, gases and vapours) to enter the body, including respiratory system, dermal and
[1]-[3 [1, 2, 3] ]
ingestion. Of these routes, the respiratory system is the most important and dominant way of entry. .
Therefore, protection of the respiratory system is of particular importance, justifying the use of masksmask
media of a high level of protection. The emergence of the coronavirus pandemic and airborne particulate
matter (PM) pollution has led to remarkably high demand for face mask,masks and, as a result, the market for
protective face masks has significantly increased. In this regard, polymeric fibrous media have been
developed. Fibrous media containing nano-object(s), such as nanofibers and/or nanoparticles, have shown
enhanced performance in trapping ultrafine particles, microbes and viruses, at lower pressure drops
compared to previous types (mask media without nano-object(s)). Nano-object(s) maycan be coated on the
surface of face mask fibres/nano fibres or maynanofibres, or can also be embedded within the polymeric
fibres/ or nanofibres themselves. Two major production methods for face mask fibrous media, includes the
melt blowing and electrospinning processes. Both processes involve the production of fibres/nano bres or
nanofibres that can serve as a matrix where nano-object(s) can be embedded or surface-applied. Despite the
above-mentioned performance advantages, face mask media containing nano-object(s) can potentially lead to
unforeseen environmental and human health hazards due to the possible release of nano-object(s) during
their life cycle. Releases of component nano-object(s) from face masks maycan occur as a result of their
design/, manufacture, misuse and/or improper handling.
Nano-object(s) couldcan be released into different media (such as air, sweat, effluent water) during product
[4],[5 [4, 5] ]
use and care. . Generally, data on the fraction of nano-object(s) release from textile materials and
products, especially into the air, is limited. Research shows that the total amount of nanoparticles released
from investigated textiles ranges from less than 1 % to nearly 100 %, depending on the content of
nanoparticles contained within the textiles. In some textiles, the amount of nanoparticle release was lower
[6],[7 [6, 7] ]
than the detection limit of the implemented measuring equipment. . The nature of the fabric is also one
of the other factors affecting the release of nanoparticles. Among the investigated textiles, those with synthetic
[6],[7 [6, 7] ]
fibres showed the highest release. . Furthermore, the release behaviour of particles from a matrix
[8 [8] ]
depends on how the particles are attached or embedded in it. . Currently, no technical standard exists in
the public domain to detect the possible release of component nano-object(s) from face masks.
This document aims to fill this gap by specifying a test method for detection of nano-object(s) that maycan be
released from medical (surgical) face masks, respirators and barrier face coverings containing
nanomaterial(s). In addition, this document also describes the sampling procedure and qualitative
characterization methods for released nano-object(s). Moreover, the development of this document will
facilitate communication between user and manufacturer/ or producer and lead to the enhancement of the
related market.
© ISO 2024 – All rights reserved
v
Nanotechnologies — A test method for detection of nano-object(s)
release from mask media
1 Scope
This document specifies a test method for the detection of nano-object(s) release despite, irrespective of its
causes, from medical (surgical) face masks, respirators and barrier face coverings [reusable (regardless of
washing characteristics) and disposable types] containing nano-object(s)), irrespective of the type of
production technology.
In addition, this TS also provides the sampling procedures and qualitative characterization methods for
released nano-object(s). This TS couldcan be used to show the possible exposure due to release, which can
relates to human health and safety.
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/TS ISO 16890-2, Air filters for general ventilation — Part 2: Measurement of fractional efficiency and air
flow resistance
ISO 26824, Particle characterization of particulate systems — Vocabulary
ISO 27891, Aerosol particle number concentration — Calibration of condensation particle counters
ISO 15167, Petroleum products — Determination of particulate content of middle distillate fuels — Laboratory
filtration method
ISO/TS 16976-1, Respiratory protective devices — Human factors — Part 1: Metabolic rates and respiratory
flow rates
ISO/TS 23302:2021, Nanotechnologies — Requirements and recommendations for the identification of
measurands that characterise nano-objects and materials that contain them.
ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
BS EN 1822-4, High efficiency air filters (EPA, HEPA and ULPA) - Determining leakage of filter elements (scan
method)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80004-1, ISO 80004-6,
ISO/TS 16976-1, BS EN 14683, ISO16890ISO 16890-2, ISO, BS EN 1822-4, ISO 29464, and ISO 27891, ASTM
F2100, ASTM F3502,and ISO 26824, and 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/
Field Code Changed
© ISO 2024 – All rights reserved
3.1 3.1
barrier face covering

product worn on the face specifically covering at least the wearer s nose and mouth with the primary purpose
providingto provide source control and to provide a degree of particulate filtration to reduce the amount of
inhaled particulate matter
Note 1 to entry: The barrier face coverings are intended to be reusable or disposable.
Note 2 to entry: reusable referringReusable refers to the ability of a product to be used and laundered or cleaned
multiple times and maintain in specific performance characteristic.
[SOURCE: ASTM F3502-21:2021, 3.1.3]
3.2 3.2
downstream
area or region into which fluid flows on leaving the test device
[SOURCE: ISO 29464:20172024, 3.1.11]16,modified — "An air cleaner" changed to "the test device".]
3.3 3.3
face velocity
volumetric air flow rate divided by the filter face area
Note 1 to entry:  Filter face velocity is expressed in m/s or cm/s.
[SOURCE: ISO 29464:20172024, 3.1.8]20, modified — "Nominal air cleaner" replaced by "filter" and note to
entry replaced.]
3.4 3.4
mask media
materials used in the mask for capturing the contaminants
3.5 3.5
medical (surgical) face mask
medical device covering the mouth and nose providing a barrier to minimize the direct transmission of
i
...

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