1、BSI Standards PublicationNanomaterials Quantification of nano-object release from powders by generation of aerosolsPD CEN ISO/TS 12025:2015National forewordThis Published Document is the UK implementation of CEN ISO/TS 12025:2015.The UK participation in its preparation was entrusted to Technical Com
2、mittee NTI/1, Nanotechnologies.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Instituti
3、on 2015 Published by BSI Standards Limited 2015 ISBN 978 0 580 88462 7 ICS 07.030Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 28 February 2013.Amendments/co
4、rrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 12025:2015It is identical to ISO/TS 12025:2012. It supersedes PD ISO/TS 12025:2012, 31 July 2015 This corrigendum renumbers PD ISO/TS 12025:2012 as ISO 2015 All rights reservedwhich is withdrawn.PD CEN ISO/TS 12025:20
5、15TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 12025 May 2015 ICS 07.030 English Version Nanomaterials - Quantification of nano-object release from powders by generation of aerosols (ISO/TS 12025:2012) Nanomatriaux - Quantification de la libration de nano-objets
6、 par les poudres par production darosols (ISO/TS 12025:2012) Nanomaterialien - Quantifizierung der Freisetzung von Nanoobjekten aus Pulvern durch Aerosolerzeugung (ISO/TS 12025:2012) This Technical Specification (CEN/TS) was approved by CEN on 16 May 2015 for provisional application. The period of v
7、alidity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in t
8、he same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN m
9、embers are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Por
10、tugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any
11、form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 12025:2015 E ISO 2015 All rights reservedForeword The text of ISO/TS 12025:2012 has been prepared by Technical Committee ISO/TC 229 “Nanotechnologies” of the International Organization for Standardization (ISO) an
12、d has been taken over as CEN ISO/TS 12025:2015 by Technical Committee CEN/TC 352 “Nanotechnologies” the secretariat of which is held by AFNOR. 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 re
13、sponsible 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 announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estoni
14、a, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The te
15、xt of ISO/TS 12025:2012 has been approved by CEN as CEN ISO/TS 12025:2015 without any modification. ISO 2015 All rights reservedii PD CEN ISO/TS 12025:2015ISO/TS 12025:2015 (E)iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms, definitions and abbreviated terms 13.1
16、General terms . 13.2 Terms related to particle properties and measurement . 24 Symbols 45 Factors influencing results of nano-object release from powders . 55.1 Test method selection . 55.2 Material properties influencing nano-object release from powder 55.3 Test stages . 66 Test requirements . 76.1
17、 General . 76.2 Safety assessment . 76.3 Sample preparation 86.4 Sample treatment . 86.5 Measurement of aerosolized nano-objects 107 Requirements for test setups and protocols 148 Data reporting 15Annex A (informative) Considerations for the selection of the treatment procedure .16Annex B (informati
18、ve) Rotating drum and continuous drop methods 18Annex C (informative) Vortex shaker method .21Annex D (informative) Dynamic method 23Annex E (informative) Disagglomeration principles 26Annex F (informative) Selection of the nano-object measuring method .27Bibliography .30 ISO 2015 All rights reserve
19、dPD CEN ISO/TS 12025:2015ISO/TS 12025:2015 (E)ForewordISO (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 memb
20、er 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 Ele
21、ctrotechnical 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.In other circumstances, particularly when there is an urgent market requirement for such documents, a technica
23、l committee may decide to publish other types of document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a
24、vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote.An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it
25、will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn.Attention is dra
26、wn 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/TS 12025 was prepared by Technical Committee ISO/TC 229, Nanotechnologies.iv ISO 2015 All rights reservedPD CEN IS
27、O/TS 12025:2015ISO/TS 12025:2015 (E)IntroductionThe emissions or release of nano-objects into the surrounding air from powdered nanostructured materials resulting from handling is an important consideration in the design and operation of many industrial processes. Released nano-objects may affect hu
28、man health and the environment, depending on the nature and quanitity of the nanomaterial. It is therefore important to obtain data about the propensity of nanomaterials to release nano-objects, thereby allowing exposure to be evaluated, controlled and minimised.Three main target groups of experts f
29、or the evaluation of the release of nano-objects from powdered nanostructured materials are: material scientists and engineers, who design safe nanomaterials and safe nanomaterial handling processes; occupational, health and safety specialists; environmental specialists, who need exposure data in ad
30、dition to toxicity data for risk assessment of manufactured nanomaterials (see A.2) and who collect dustiness data (gravimetric as well as particle concentration and particle size information).The propensity of nanomaterials to release nano-objects into the air is determined by test methods devised
31、to apply energy to a sample to stress the intra-particle bonds. This stressing induces abrasion, erosion or comminution, which causes dissemination of the particles into the gaseous phase, i.e. generation of aerosols allowing quantification with aerosol instrumentation.Methods to measure the release
32、 of nano-objects from nanomaterials may include dustiness testing methods but basic differences from conventional dustiness methods should be considered. The high variability of the flow properties of powders and the influence of the test setup should also be considered. Conventional dustiness metho
33、ds for micrometre size particles estimate the amount of dust generated in terms of dust mass fraction or dustiness indices. The methods of aerosol generation for the determination of the dustiness of powders containing primary particles of less than 10 m in diameter have been found to produce very d
34、issimilar results.There are a large number of possible combinations of different approaches for the design of dustiness methods1. The only current standard, EN 15051:20062, selected two methods: the rotating drum method and continuous drop method. The measured values are the inhalable, thoracic or r
35、espirable mass fractions, expressed in mg/kg.Definitions of the inhalable, thoracic and respirable fractions can be found in EN 4813. Aerodynamic diameters of 100 m, 10 m and 4 m are the upper limits of the corresponding size fractions. These mass fractions, which are relevant for inhalation, can be
36、 added as measurands in measurement of aerosolised nano-objects to characterize the complete particle release scenario.Schneider and Jensen4described approaches using particle size distributions by number to relate exposure from nano-objects in the indoor environment to source strengths resulting fr
37、om the release of nano-objects during the handling of nanostructured powders. They concluded that dustiness testing combined with online size distribution measurements provides insight into the state of agglomeration of particles released during handling of bulk powder materials.Furthermore, the eva
38、luation of the release of nano-objects from powdered nanostructured materials requires additional methods and measurands compared to the methods assessing the dustiness of powders. Particle number concentration and size distribution are other measurands necessary for quantifying the release of nano-
39、objects.Aerosols of nano-objects are more dynamic than micrometre sized particles because of greater sensitivity to physical effects such as Brownian diffusion. Porosity and cohesion of the powder can be much higher than those containing larger particles with more resistance to flow and lower volume
40、-specific surface area. Nano-objects in powdered materials can dominate relevant properties of the bulk material by particle-particle interactions that form clusters like agglomerates. There is still a lack of understanding v ISO 2015 All rights reservedPD CEN ISO/TS 12025:2015ISO/TS 12025:2015 (E)i
41、n the characterization of these secondary nanostructured particles, consisting of primary nano-objects. It has been shown for fumed silica, as an example, that the resulting aerosol particle size distribution depends strongly upon the conditions involved in the different measuring methods56.Aerosols
42、 and powders are also generated by tribological abrasive tests7of nano-composites and paints containing nanoparticles89. Such abrasion tests are not addressed by this Technical Specification. However, the measurement methodology of these publications has been proven for the quantification of nano-ob
43、ject release from wear powders by generation of aerosols.vi ISO 2015 All rights reservedPD CEN ISO/TS 12025:2015ISO/TS 12025:2015 (E)TECHNICAL SPECIFICATION Nanomaterials Quantification of nano-object release from powders by generation of aerosolsWARNING The execution of the provisions of this docum
44、ent should be entrusted only to appropriately qualified and experienced people, for whose use it has been produced.1 ScopeThis Technical Specification provides methodology for the quantification of nano-object release from powders as a result of treatment, ranging from handling to high energy disper
45、sion, by measuring aerosols liberated after a defined aerosolization procedure. In addition to information in terms of mass, the aerosol is characterized for particle concentrations and size distributions. This Technical Specification provides information on factors to be considered when selecting f
46、rom the available methods for powder sampling and treatment procedures and specifies minimum requirements for test sample preparation, test protocol development, measuring particle release and reporting data. In order to characterize the full size range of particles generated, the measurement of nan
47、o-objects as well as agglomerates and aggregates is recommended in this Technical Specification.This Technical Specification does not include the characterization of particle sizes within the powder. Tribological methods are excluded where direct mechanical friction is applied to grind or abrade the
48、 material.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO/TS 27687:2008, Nanotechnologies Terminology and definitions for nano
49、-objects nanoparticle, nanofibre and nanoplateISO/TS 80004-1, Nanotechnologies Vocabulary Part 1: Core terms3 Terms, definitions and abbreviated termsFor the purposes of this document, the terms and definitions given in ISO/TS 27687 and ISO/TS 80004-1 and the following apply.3.1 General terms3.1.1release from powdertransfer of material from a powder to a liquid or gas as a consequence of a disturbance3.1.2nano-object number releasentotal number of nano-objects, released from a sample as a consequence of a distu
