EN ISO 10801:2010
(Main)Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method (ISO 10801:2010)
Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method (ISO 10801:2010)
ISO 10801:2010 gives requirements and recommendations for generating metal nanoparticles as aerosols suitable for inhalation toxicity testing by the evaporation/condensation method. Its application is limited to metals such as gold and silver which have been proven to generate nanoparticles suitable for inhalation toxicity testing using the technique specified.
Nanotechnologien - Erzeugung von Metall-Nanopartikeln zur Prüfung auf Toxizität nach Inhalation unter Verwendung des Verdampfungs-/Kondensationsverfahrens (ISO 10801:2010)
Diese Internationale Norm liefert Anforderungen und Empfehlungen zur Erzeugung von Metall-Nanopartikeln
als Aerosole, die für die Inhalationstoxizitätsprüfung geeignet sind, mit Hilfe des Verdampfungs-/
Kondensationsverfahrens. Seine Anwendung ist auf Metalle, wie Gold und Silber, beschränkt, für die
nachgewiesen wurde, dass für die Prüfung auf Toxizität nach Inhalation geeignete Nanopartikel nach dem
hier festgelegtem Verfahren (siehe Anhang A) erzeugt werden können.
Nanotechnologies - Génération de nanoparticules de métal pour essais de toxicité par inhalation en utilisant la méthode de condensation/évaporation (ISO 10801:2010)
L'ISO 10801:2010 donne des exigences et des recommandations pour générer des nanoparticules métalliques comme aérosols adéquats pour les essais de toxicité par inhalation par la méthode d'évaporation/condensation. Elle se limite aux métaux tels que l'or et l'argent, qui se sont révélés générer des nanoparticules appropriées aux essais de toxicité par inhalation lorsque ladite méthode est utilisée
Nanotehnologija - Pridobivanje kovinskih nanodelcev za preskušanje toksičnosti z uporabo metode izparevanja/kondenzacije (ISO 10801:2010)
Ta mednarodni standard podaja zahteve in priporočila za pridobivanje kovinskih nanodelcev kot aerosolov, primernih za preskušanje toksičnosti z uporabo metode izparevanja/kondenzacije. Njegova uporaba je omejena na kovine, kot so zlato in srebro, za katere je bilo dokazano, da tvorijo nanodelce, primerne za preskušanje toksičnosti z uporabo tehnike, ki jo določa (glej dodatek A).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2011
1DQRWHKQRORJLMD3ULGRELYDQMHNRYLQVNLKQDQRGHOFHY]DSUHVNXãDQMHWRNVLþQRVWL]
XSRUDERPHWRGHL]SDUHYDQMDNRQGHQ]DFLMH ,62
Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using
the evaporation/condensation method (ISO 10801:2010)
Nanotechnologien - Erzeugung von Silbernanopartikeln zur Prüfung auf Toxizität nach
Inhalation (ISO 10801:2010)
Nanotechnologies - Génération de nanoparticules en métal pour essais de toxicité par
inhalation en utilisant la méthode de condensation/évaporation (ISO 10801:2010)
Ta slovenski standard je istoveten z: EN ISO 10801:2010
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10801
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 07.030
English Version
Nanotechnologies - Generation of metal nanoparticles for
inhalation toxicity testing using the evaporation/condensation
method (ISO 10801:2010)
Nanotechnologies - Génération de nanoparticules de métal Nanotechnologien - Erzeugung von Metall-Nanopartikeln
pour essais de toxicité par inhalation en utilisant la zur Prüfung auf Toxizität nach Inhalation unter Verwendung
méthode de condensation/évaporation (ISO 10801:2010) des Verdampfungs-/Kondensationsverfahrens (ISO
10801:2010)
This European Standard was approved by CEN on 14 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 10801:2010: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 10801:2010) 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 10801:2010 has been approved by CEN as a EN ISO 10801:2010 without any modification.
INTERNATIONAL ISO
STANDARD 10801
First edition
2010-12-15
Nanotechnologies — Generation of metal
nanoparticles for inhalation toxicity
testing using the
evaporation/condensation method
Nanotechnologies — Génération de nanoparticules de métal pour
essais de toxicité par inhalation en utilisant la méthode de
condensation/évaporation
Reference number
ISO 10801:2010(E)
©
ISO 2010
ISO 10801:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 10801:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Principle .3
4.1 Generation.3
4.2 Preparation of system.4
5 Requirements.4
5.1 Capacity and control.4
5.2 Nanoparticle properties .5
5.3 Exposure chamber atmosphere.5
5.4 System operational safety.5
6 Characterization of generator performance .6
6.1 Requirements for particle size distribution and mass concentration .6
6.2 Particle size distribution measurement .6
6.2.1 Sampling with DMAS.6
6.2.2 Sampling for microscopy .6
6.3 Mass concentration measured by filter sampling.6
6.3.1 Filter sampling for aerosol mass concentration .7
6.3.2 Frequency of sampling .7
7 Nanoparticle generation specifications .7
7.1 Test particle purity/impurities .7
7.2 Size range.7
7.3 Number concentration .7
7.4 Nanoparticle shape .7
7.5 Stability.7
7.6 Animal exposure.8
8 Assessment of results .8
9 Test report.8
Annex A (informative) Example method for evaporation/condensation generation of silver
nanoparticles .9
Bibliography.21
ISO 10801:2010(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 10801 was prepared by Technical Committee ISO/TC 229, Nanotechnologies.
iv © ISO 2010 – All rights reserved
ISO 10801:2010(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 manufactured nanoparticles. If nanoparticles are liberated from products, the
public could be exposed as well.
There is currently limited, but growing, knowledge about the toxicity of nano-sized particles. The processes of
nanoparticle production include gas-phase, vapour-phase, colloidal and attrition processes. Potential paths of
exposure include inhalation, dermal and ingestion. Inhalation may arise from direct leakage from gas-phase
and vapour-phase processes, airborne contamination of the workplace from deposition or product recovery
[7]
and handling of product, or post-recovery processing and packing . Exposure to manufactured nano-sized
particles might occur during production, use and disposal in the ambient air or workplace and is of concern for
public and occupational health.
There are currently neither generally accepted methods of inhalation toxicology testing for nano-sized
particles nor specific nanoparticle generation methods for such testing. The ability to disperse respirable nano-
sized particles from powders has bee
...
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