EN ISO 10808-2010 en Nanotechnologies - Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing《纳米技术 纳米粒子在吸入暴露室的吸入毒性测试表征》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10808:2010Nanotechnologies Characterization ofnanoparticles in inhalationexposure chambers forinhalation toxicity testing (ISO10808:2010)BS EN ISO 10808:2010 BRITISH ST

2、ANDARDNational forewordThis British Standard is the UK implementation of EN ISO10808:2010.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.This publicat

3、ion does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 65936 2ICS 07.030Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority

4、 of theStandards Policy and Strategy Committee on 31 January 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10808 December 2010 ICS 07.030 English Version Nanotechnologies - Characterization of nanoparticles in inhalation exposure c

5、hambers for inhalation toxicity testing (ISO 10808:2010) Nanotechnologies - Caractrisation des nanoparticules dans les chambres dinhalation par exposition pour les essais de toxicit par inhalation (ISO 10808:2010) Nanotechnologien - Charakterisierung von Nanopartikeln in Inhalationskammern zur Prfun

6、g auf Toxizitt nach 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 alt

7、eration. 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 ma

8、de 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, Esto

9、nia, 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 COMIT EUROPEN DE NORMALISATION EURO

10、PISCHES 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 10808:2010: EBS EN ISO 10808:2010EN ISO 10808:2010 (E) 3 Foreword This document (EN ISO 10808:

11、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

12、 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 responsibl

13、e 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, F

14、rance, 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 10

15、808:2010 without any modification. BS EN ISO 10808:2010ISO 10808:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 3.1 Particle measuring systems.2 4 Test substance monitoring method 4 4.1 Principle .4 4.1.1 E

16、xposure 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 In

17、halation exposure chamber 6 6 Assessment of results 7 7 Test report7 Annex A (informative) Example of nanoparticle characterization for inhalation toxicity testing.9 Bibliography17 BS EN ISO 10808:2010ISO 10808:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for S

18、tandardization) 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 ri

19、ght 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. Internationa

20、l 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

21、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

22、 10808 was prepared by Technical Committee ISO/TC 229, Nanotechnologies. BS EN ISO 10808:2010ISO 10808:2010(E) ISO 2010 All rights reserved vIntroduction The number of nanotechnology-based consumer products containing silver, gold, carbon, zinc oxide, titanium dioxide and silica nanoparticles is gro

23、wing 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

24、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

25、is the norm at this time, it is desirable to replace this antiquated method with a human-relevant assay10. 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 m

26、onitoring 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 (

27、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 numbe

28、r, 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

29、 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 effective analysis o

30、f inhalation toxicity testing results 131718. BS EN ISO 10808:2010BS EN ISO 10808:2010INTERNATIONAL STANDARD ISO 10808:2010(E) ISO 2010 All rights reserved 1Nanotechnologies Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing 1 Scope This International S

31、tandard 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 foll

32、owing 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 10312, Ambient air Determination of asbestos fibres D

33、irect transfer transmission electron microscopy method ISO 15900, Determination of particle size distribution Differential electrical mobility analysis for aerosol particles ISO/TS 27687, Nanotechnologies Terminology and definitions for nano-objects Nanoparticle, nanofibre and nanoplate OECD Test Gu

34、ideline 403 (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)OECD Guidance Document 39 (GD 39), Acute Inhalation Toxicity Testing1)3 Terms and definitions

35、 For the purposes of this document, the terms and definitions given in ISO 15900 and ISO/TS 27687 and the following apply. 1) Organization for Economic Cooperation and Development (OECD) publication. BS EN ISO 10808:2010ISO 10808:2010(E) 2 ISO 2010 All rights reserved3.1 Particle measuring systems 3

36、.1.1 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 classifies aerosol particle sizes by balancing t

37、he 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 physical dimensions of the DEMC. NOTE

38、2 Adapted from ISO 15900:2009, definition 2.7. 3.1.2 differential mobility analyzing 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, interconnecting plumbing, a computer

39、 and suitable software NOTE Adapted from ISO 15900:2009, definition 2.8. 3.1.3 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 detected are u

40、sually 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 Adapted from ISO 15900:2009, definition 2.5. 3.2 inhal

41、ation 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” or “snout-only”. NOTE 2 Ad

42、apted from OECD TG 403, 412, 413. 3.3 nanoparticle generation system device used to make nanoparticle aerosol with controlled size distribution and concentration 3.4 breathing zone location from which the experimental animal breathes NOTE 1 For an unrestrained, non-caged animal, this will be the ent

43、ire volume of the inhalation chamber. For a restrained or caged animal, this will be the range of motion for the animals nose. For a masked animal, this will be the small volume in front of the nostrils. BS EN ISO 10808:2010ISO 10808:2010(E) ISO 2010 All rights reserved 3NOTE 2 The term “breathing z

44、one” is used to ensure test atmosphere samples are obtained from the same location as that in which the animal breathes. An undesirable sampling approach would be one where concentration measurements are obtained at the top of the inhalation chamber while the animal is exposed at the bottom. 3.5 geo

45、metric mean diameter GMD measure of 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 the size channel, i; N is the total concentration; Niis the concentration within the size ch

46、annel, i; m 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. 3.6 geometric standard deviation GSD measure of width or spread of particle sizes, computed for t

47、he DMAS by ()2ln ln GMDln(GSD)1niiimNdN=3.7 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,

48、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 = 3 is the volume or mass; BS EN ISO 10808:2010ISO 10808:2010(E) 4 ISO 2010 All rights reservedr is the dimensionality (type of quantity) of a distribution,

49、where r = 0 is the number, r = 1 is the length, r = 2 is the area, and r = 3 is the volume or mass; s is the standard deviation of the density distribution; x50,ris the median particle size of a cumulative distribution of dimensionality, r. 4 Test substance monitoring method 4.1 Principle 4.1.1 Exposure Precise characterization of the test substance exposure is essential for an inhalation toxicology study. The objective in nanoparticle inhalation toxicology is to establish a quantitative relationship between the obs