1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10801:2010Nanotechnologies Generation of metalnanoparticles for inhalationtoxicity testing using theevaporation/condensationmethod (ISO 10801:2010)Licensed Copy: Wang B
2、in, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10801:2010.The UK participation in its preparation was entrusted to TechnicalCommittee NTI/1, Nanotechnologies.A
3、 list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 61398 2ICS 07.030Compliance with a British
4、Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 January 2011.Amendments issued since publicationDate Text affectedLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03,
5、 Uncontrolled Copy, (c) BSIEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10801 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 - Gnrati
6、on de nanoparticules de mtal pour essais de toxicit par inhalation en utilisant la mthode de condensation/vaporation (ISO 10801:2010) Nanotechnologien - Erzeugung von Metall-Nanopartikeln zur Prfung auf Toxizitt nach Inhalation unter Verwendung des Verdampfungs-/Kondensationsverfahrens (ISO 10801:20
7、10) 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 bibliographica
8、l 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 o
9、f 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, Hunga
10、ry, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre
11、: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10801:2010: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010EN ISO
12、 10801:2010 (E) 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 n
13、ational 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
14、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, Croati
15、a, 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
16、 ISO 10801:2010 has been approved by CEN as a EN ISO 10801:2010 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010ISO 10801:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v
17、1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Principle .3 4.1 Generation3 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 safety5 6 Characterization of generator performanc
18、e .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 sampling6 6.3.1 Filter sampling for aerosol mass concentration 7 6.3.2 Fre
19、quency 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 exposure8 8 Assessment of results 8 9 Test report8 Annex A (informative) Example method for evaporat
20、ion/condensation generation of silver nanoparticles .9 Bibliography21 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010ISO 10801:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardizati
21、on) 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 re
22、presented 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
23、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 Internati
24、onal 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 p
25、repared by Technical Committee ISO/TC 229, Nanotechnologies. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010ISO 10801:2010(E) ISO 2010 All rights reserved vIntroduction The number of nanotechnology-based consumer products contai
26、ning 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 ma
27、nufactured 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 attritio
28、n 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 and handling of product, or post-recovery processing and
29、packing7. 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 particl
30、es nor specific nanoparticle generation methods for such testing. The ability to disperse respirable nano-sized particles from powders has been an obstacle to evaluating the effects of inhalation of nano-sized particles on the respiratory system. Although it is possible to disperse nanoparticles in
31、air from powders, the size of the particles so generated may be larger than desired due to aggregation and agglomeration. In order to gain vital information for evaluating the health effects of nanoparticles by inhalation, nano-sized particles need to be generated and transported to a test environme
32、nt containing experimental animals for testing short- or long-term inhalation toxicity. The nanoparticle generation method based on evaporation of metal (silver in this example) and subsequent condensation is capable of providing a consistent particle size distribution and stable number concentratio
33、ns, suitable for short- or long-term inhalation toxicity study. This International Standard provides a method for stable silver nanoparticle generation with particle sizes up to 100 nm. A detailed method is described in Annex A. The generation method provided here has sufficient stability for contin
34、uous inhalation toxicity testing up to 90 days. The generated nanoparticles can be used in various experimental systems, including high-throughput human cell-based labs-on-a-chip, a variety of additional in-vitro methods 891011, as well as the animal experiments that may still be performed at this t
35、ime, which include, but are not limited to, whole-body, head-only and nose-only. The method is not limited to the silver nanoparticles used in this example and may be used to generate other metallic nanoparticles with a similar melting temperature and evaporation rate, such as gold. However, this me
36、thod is not applicable to the generation of nanoparticles of all metals. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO
37、 10801:2010INTERNATIONAL STANDARD ISO 10801:2010(E) ISO 2010 All rights reserved 1Nanotechnologies Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method 1 Scope This International Standard gives requirements and recommendations for generating met
38、al 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 it specifies (see A
39、nnex A). 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/TS 27687, Nan
40、otechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate ISO 15900, Determination of particle size distribution Differential electrical mobility analysis for aerosol particles ISO/IEC 17025, General requirements for the competence of testing and calibration la
41、boratories OECD Test Guideline (TG) 403, Acute Inhalation Toxicity1)OECD Test Guideline 412 (TG) 412, Subacute Inhalation Toxicity: 28-Day Study1)OECD Test Guideline 413 (TG) 413, Subchronic Inhalation Toxicity: 90-day Study1)3 Terms and definitions For the purposes of this document, the terms and d
42、efinitions given in ISO/TS 27687 and ISO 15900 and the following apply. 3.1 differential mobility analysing system DMAS system used to measure the size distribution of submicrometre aerosol particles consisting of a DEMC, a particle charge conditioner, flow meters, a particle detector, interconnecti
43、ng plumbing, a computer and suitable software NOTE Adapted from ISO 15900:2009, definition 2.8. 1) Organization for Economic Cooperation and Development (OECD) publication. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 18/04/2011 04:03, Uncontrolled Copy, (c) BSIBS EN ISO 10801:2010ISO 1080
44、1:2010(E) 2 ISO 2010 All rights reserved3.2 differential electrical mobility classifier DEMC differential electrical mobility spectrometer DEMS classifier that is able to select aerosol particle sizes from a distribution that enters it and pass only selected sizes to the exit NOTE 1 A DEMC classifie
45、s aerosol particle sizes by balancing the electrical force on each particle in an electrical field with its aerodynamic drag force. Classified particles have different sizes due to their number of electrical charges and a narrow range of electrical mobility determined by the operating conditions and
46、 physical dimensions of the DEMC. NOTE 2 Adapted from ISO 15900:2009, definition 2.7. 3.3 condensation particle counter CPC instrument that detects particles and that can be used to calculate particle number concentration given the known flow rates into the detector NOTE 1 The range of particles det
47、ected are usually smaller than several hundred nanometers and larger than a few nanometers. A CPC is one possible detector for use with a DEMC. NOTE 2 In some cases, a condensation particle counter may be called a condensation nucleus counter (CNC). NOTE 3 This definition is different from the one g
48、iven in ISO 15900. 3.4 inhalation exposure chamber inhalation chamber exposure chamber system prepared to expose experimental animals to an inhaled test substance of predetermined duration and dose by either the nose-only or whole-body method NOTE 1 The term “nose-only” is synonymous with “head-only
49、” or “snout-only”. NOTE 2 Adapted from OECD TG 403, OECD TG 412, OECD TG 413. 3.5 evaporation/condensation nanoparticle generator system device used to make a nanoparticle aerosol by the evaporation/condensation method, which can be connected to an inhalation chamber or other toxicity testing device 3.6 geometric mean diameter GMD measure of the central tendency of particle size distribution using the logarithm of particle diameters, computed for the DMAS by ()lnln(GMD)niiimNdN=where diis the midpoint diameter for size channel i; N i
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