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)BS EN ISO 10801:2010
2、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 list of organizations represented on this committee can beobtained on request to its secretary.Thi
3、s 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 Standard cannot confer immunity fromlegal obligations.This British Standard was published under the
4、 authority of theStandards Policy and Strategy Committee on 31 January 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10801 December 2010 ICS 07.030 English Version Nanotechnologies - Generation of metal nanoparticles for inhalation
5、 toxicity testing using the evaporation/condensation method (ISO 10801:2010) Nanotechnologies - Gnration 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
6、 auf Toxizitt nach Inhalation unter Verwendung 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
7、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 (En
8、glish, 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
9、, 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 COMMITT
10、EE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: 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: EBS EN ISO 10801:2010EN
11、ISO 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
12、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 pate
13、nt 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, Cro
14、atia, 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
15、 of ISO 10801:2010 has been approved by CEN as a EN ISO 10801:2010 without any modification. BS EN ISO 10801:2010ISO 10801:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Principle .3 4.1 Generation3 4.2 P
16、reparation 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 performance .6 6.1 Requirements for particle size distribution and mass concentration .6 6.2 Particle size
17、 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 Frequency of sampling .7 7 Nanoparticle generation specifications 7 7.1 Test particle purity/impuri
18、ties 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 evaporation/condensation generation of silver nanoparticles .9 Bibliography21 BS EN ISO 10801:2010ISO 10
19、801:2010(E) iv ISO 2010 All rights reservedForeword 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
20、 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 Elect
21、rotechnical 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 adopte
22、d 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
23、 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. BS EN ISO 10801:2010ISO 10801:2010(E) ISO 2010 All rights reserved vIntroduction The number of nanotechnology-based consumer products
24、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
25、 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 at
26、trition 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 processin
27、g and 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 p
28、articles 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 nanoparticl
29、es in 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 env
30、ironment 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 concen
31、trations, 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
32、continuous 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
33、this time, 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, t
34、his method is not applicable to the generation of nanoparticles of all metals. BS EN ISO 10801:2010BS EN ISO 10801:2010INTERNATIONAL STANDARD ISO 10801:2010(E) ISO 2010 All rights reserved 1Nanotechnologies Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/conde
35、nsation method 1 Scope This International Standard 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 prove
36、n to generate nanoparticles suitable for inhalation toxicity testing using the technique it specifies (see Annex 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 ref
37、erences, the latest edition of the referenced document (including any amendments) applies. ISO/TS 27687, Nanotechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate ISO 15900, Determination of particle size distribution Differential electrical mobility analysi
38、s for aerosol particles ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories 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 I
39、nhalation Toxicity: 90-day Study1)3 Terms and definitions For the purposes of this document, the terms and definitions 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 pa
40、rticles consisting of a DEMC, a particle charge conditioner, flow meters, a particle detector, interconnecting plumbing, a computer and suitable software NOTE Adapted from ISO 15900:2009, definition 2.8. 1) Organization for Economic Cooperation and Development (OECD) publication. BS EN ISO 10801:201
41、0ISO 10801:2010(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
42、classifies 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 condi
43、tions and 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 part
44、icles detected 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
45、the one given 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 “
46、head-only” 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 testi
47、ng 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 is the total concentration; Niis the concentration wi
48、thin size channel i; BS EN ISO 10801:2010ISO 10801:2010(E) ISO 2010 All rights reserved 3m is the first channel; n is the last channel. NOTE The GMD is normally computed from particle counts and, when noted, may be based on surface area or particle volume with appropriate weighting. 3.7 geometric st
49、andard deviation GSD measure of width or spread of particle sizes, computed for the DMAS by ()2ln ln GMDln(GSD)1niiimNdN=3.8 count median diameter CMD diameter equal to GMD for particle counts assuming a logarithmic normal distribution NOTE The general form of the relationship as described in ISO 9276-5 is ()250, 50,CMD erpsrpxx= where e is the base of natural logarithms, e = 2,718 28; p is the dimensionality (type of quantity) of a distribution, where p = 0 is the number, p = 1 is the length, p = 2 is the area, and p
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