EN ISO 10808:2010

SLOVENSKI STANDARD
01-november-2011
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Nanotechnologies - Characterization of nanoparticles in inhalation exposure chambers
for inhalation toxicity testing (ISO 10808:2010)
Nanotechnologien - Charakterisierung von Nanopartikeln in Inhalationskammern zur
Prüfung auf Toxizität nach Inhalation (ISO 10808:2010)
Nanotechnologies - Caractérisation des nanoparticules dans les chambres d'inhalation
par exposition pour les essais de toxicité par inhalation (ISO 10808:2010)
Ta slovenski standard je istoveten z: EN ISO 10808:2010
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10808
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 07.030
English Version
Nanotechnologies - Characterization of nanoparticles in
inhalation exposure chambers for inhalation toxicity testing (ISO
10808:2010)
Nanotechnologies - Caractérisation des nanoparticules Nanotechnologien - Charakterisierung von Nanopartikeln in
dans les chambres d'inhalation par exposition pour les Inhalationskammern zur Prüfung auf Toxizität nach
essais de toxicité par inhalation (ISO 10808:2010) Inhalation (ISO 10808:2010)
This European Standard was approved by CEN on 10 December 2010.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10808:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 10808:2010) has been prepared by Technical Committee ISO/TC 229
“Nanotechnologies” in collaboration with Technical Committee CEN/TC 352 “Nanotechnologies” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10808:2010 has been approved by CEN as a EN ISO 10808:2010 without any modification.

INTERNATIONAL ISO
STANDARD 10808
First edition
2010-12-15
Nanotechnologies — Characterization of
nanoparticles in inhalation exposure
chambers for inhalation toxicity testing
Nanotechnologies — Caractérisation des nanoparticules dans les
chambres d'inhalation par exposition pour les essais de toxicité par
inhalation
Reference number
ISO 10808:2010(E)
©
ISO 2010
ISO 10808:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 10808:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
3.1 Particle measuring systems.2
4 Test substance monitoring method .4
4.1 Principle .4
4.1.1 Exposure .4
4.1.2 Particle properties.4
4.2 Preparation of system.4
4.3 Study.5
5 Specific monitoring method.5
5.1 Requirements for number-based particle size distribution and mass concentration .5
5.2 Measurement of number-based particle size distribution .5
5.3 Mass concentration measurement .6
5.4 Inhalation exposure chamber .6
6 Assessment of results .7
7 Test report.7
Annex A (informative) Example of nanoparticle characterization for inhalation toxicity testing.9
Bibliography.17

ISO 10808:2010(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10808 was prepared by Technical Committee ISO/TC 229, Nanotechnologies.

iv © ISO 2010 – All rights reserved

ISO 10808:2010(E)
Introduction
The number of nanotechnology-based consumer products containing silver, gold, carbon, zinc oxide, titanium
dioxide and silica nanoparticles is growing very rapidly. The population at risk of exposure to nanoparticles
continues to increase as the applications expand. In particular, workers in nanotechnology-based industries
are at risk of being exposed to nanoparticles. If nanoparticles are liberated from products, the public could be
exposed as well. Although toxicity screening using instillation of nanomaterials provides important information,
it does not reflect the actual scenario of inhalation exposure and does not provide the data required for
inhalation exposure risk assessment. In addition, while inhalation toxicology using rats is the norm at this time,
[10]
it is desirable to replace this antiquated method with a human-relevant assay .
The inhalation toxicity of nanoparticles is of particular concern in ensuring the health of workers and
consumers. In order to conduct inhalation toxicity studies of nano-sized particles, the monitoring of
concentration, size and distribution of nano-sized particles in the inhalation chamber is necessary. The
conventional methods of fine or coarse particle monitoring, such as weight-based mass dose monitoring, are
considered insufficient for nanoparticles, since nano-specific parameters (particle surface area, particle
number, etc.) might be critical determinants, and if so, should also be monitored.
This International Standard proposes a battery of inhalation toxicity testing chamber monitoring, including a
differential mobility analyzing system (DMAS), for measuring particle number, size, distribution, surface area
and estimated mass dose, as well as morphological examination using transmission electron microscopy
(TEM) or scanning electron microscopy (SEM) equipped with an energy dispersive X-ray analyzer
(TEM-EDXA) for chemical composition.
This International Standard also includes conventional mass dose monitoring and other physicochemical
monitoring, for use when deemed a necessary parameter for toxicity determination. This method evaluates
nano-sized particle surface area, mass dose, particle distribution, composition and dispersion to support
[13][17][18]
effective analysis of inhalation toxicity testing results .

INTERNATIONAL STANDARD ISO 10808:2010(E)

Nanotechnologies — Characterization of nanoparticles in
inhalation exposure chambers for inhalation toxicity testing
1 Scope
This International Standard specifies requirements for, and gives guidance on, the characterization of airborne
nanoparticles in inhalation exposure chambers for the purpose of inhalation toxicity studies in terms of particle
mass, size distribution, number concentration and composition.
2 Normative references
The following referenced documents are indispensable for the application 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
...