1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationDD ISO/TS 12805:2011Nanotechnologies Materialsspecifications Guidance onspecifying nano-objectsDD ISO/TS 12805:2011 DRAFT FOR DEVELOPMENTNational forewordThis Draft for Developme
2、nt is the UK implementation of ISO/TS12805:2011.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Development series of publicationsand is of a provisional nature. It should be applied on thisprovisional basis, so that information and experience of its
3、practicalapplication can be obtained.Comments arising from the use of this Draft for Developmentare requested so that UK experience can be reported to theinternational organization responsible for its conversion toan international standard. A review of this publication willbe initiated not later tha
4、n 3 years after its publication by theinternational organization so that a decision can be taken on itsstatus. Notification of the start of the review period will be made inan announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period,
5、the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specification or to withdraw it. Comments should be sentto the Secretary of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick Hi
6、gh Road, London W4 4AL.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 publication does not purport to include all the necessaryprovisions of a co
7、ntract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 66566 0ICS 07.030Compliance with a British Standard cannot confer immunity fromlegal obligations.This Draft for Development was published under the authority ofthe Standards Policy and Strategy Committee on 30 November
8、2011.Amendments issued since publicationDate Text affectedDD ISO/TS 12805:2011Reference numberISO/TS 12805:2011(E)ISO 2011TECHNICAL SPECIFICATION ISO/TS12805First edition2011-11-15Nanotechnologies Materials specifications Guidance on specifying nano-objects Nanotechnologies Spcifications de matriaux
9、 Lignes directrices de spcification des nano-objets DD ISO/TS 12805:2011ISO/TS 12805:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, includi
10、ng photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published
11、 in Switzerland ii ISO 2011 All rights reservedDD ISO/TS 12805:2011ISO/TS 12805:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction . v 1 Scope 1 2 Normative references 1 3 Terms and definitions . 2 4 Specifying manufactured nano-objects 2 4.1 General . 2 4.2 Nano-objects
12、having all three dimensions at the nanoscale, i.e. nanoparticles 2 4.3 Nano-objects having two dimensions at the nanoscale, i.e. nanofibres . 3 4.4 Nano-objects having one dimension at the nanoscale, i.e. nanoplates 4 5 Additional material characteristics that might influence end-product performance
13、 and/or downstream processability 5 5.1 General . 5 5.2 Characteristics known to be influential in specific areas of application . 5 5.3 Other material characteristics with a possible influence on product performance and/or downstream processability 5 6 Proposed measurement methods for determining t
14、he characteristics of manufactured nano-objects identified as important for specification purposes 6 7 Possible impacts of contamination on the properties and performance of manufactured nano-objects and their mitigation 7 Annex A (informative) Figure A.1 Decision tree to assist with the use of ISO/
15、TS 12805 8 Annex B (informative) Measurement methods . 9 Bibliography 19 DD ISO/TS 12805:2011ISO/TS 12805:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of p
16、reparing 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,
17、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 ta
18、sk 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. In othe
19、r circumstances, particularly when there is an urgent market requirement for such documents, a technical 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 accepte
20、d for publication if it is approved by more than 50 % of the members of the parent committee casting a 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 com
21、mittee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it 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
22、which time it must either be transformed into an International Standard or be withdrawn. 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/TS 12805
23、 was prepared by Technical Committee ISO/TC 229, Nanotechnologies. DD ISO/TS 12805:2011ISO/TS 12805:2011(E) ISO 2011 All rights reserved vIntroduction The need for this Technical Specification arose in response to the failure of specifications agreed between suppliers of manufactured nano-objects an
24、d their customers to ensure delivery of material that responds consistently to downstream processing or that is capable of generating consistent performance in the final product between batches and lots. This observed inconsistent performance of batches or lots of material has led to the conclusion
25、that the cause has to be related to one or more of the following scenarios. a) The specification agreed between customer and supplier does not cover all material characteristics that have an influence on performance and/or processability, or it has been interpreted differently by the customer and su
26、pplier. b) One or more material characteristic is currently being measured by an inappropriate technique. c) One or more measurement technique is being applied in an incorrect manner. This Technical Specification is intended to help address all of these issues. These same issues are also relevant to
27、 the process of initial material qualification, prior to specification and use, and some of the guidance provided can be used in this context. Each broad category of manufactured nano-object has been considered in a separate clause: those at the nanoscale in all three (orthogonal) dimensions, those
28、at the nanoscale in two (orthogonal) dimensions and those at the nanoscale in one dimension only. Many nano-objects are supplied in the form of dispersion in a liquid medium. For each broad category of nano-object, the characteristics relevant to dispersions have therefore also been identified. For
29、each category of manufactured nano-object: a list is provided of material characteristics that are considered relevant to initial material qualification in all areas of application; a list is provided of additional material characteristics that are considered relevant to material qualification in sp
30、ecific areas of application; where the use of these material characteristics in agreed specifications does not ensure batch-to-batch or lot-to-lot consistency, a further list of characteristics that might have an influence on product performance and/or downstream processing is provided for considera
31、tion; for all identified material characteristics, appropriate measurement methods are proposed, which separate into two categories: a) those generally utilising relatively low-cost equipment, which can be envisaged for use in routine batch or lot quality control in an industrial environment, and b)
32、 those which require specialist equipment and which might therefore only be viable for use in less frequent assessments; a brief description of the basis of each measurement method is provided and, wherever possible, reference is made to an appropriate source of guidance on good practice in carrying
33、 out the test (usually an established standard); where no viable or validated measurement method can currently be identified, DD ISO/TS 12805:2011ISO/TS 12805:2011(E) vi ISO 2011 All rights reservedthis is also stated. For some parameters, guidance on an appropriate measurement method is not quoted
34、because no International Standard exists for measuring such a parameter. Often, however, International Standards do exist which refer to the measurement of the parameter for specific materials or applications. Such material- or application-specific standards can be identified by searching the ISO st
35、andards database (www.iso.org). A decision tree is provided in Annex A as a guide to the use of this Technical Specification. Users of this Technical Specification should be aware that packaging, labelling and transport of materials specified in this Technical Specification may be subject to statuto
36、ry and regional regulations. It has been assumed in the preparation of this Technical Specification that the execution of its provisions will be entrusted to appropriately qualified and experienced people, for whose use it has been produced. DD ISO/TS 12805:2011TECHNICAL SPECIFICATION ISO/TS 12805:2
37、011(E) ISO 2011 All rights reserved 1Nanotechnologies Materials specifications Guidance on specifying nano-objects 1 Scope This Technical Specification provides guidance on the preparation of specifications for the characteristics of manufactured nano-objects and their measurement methods. This is i
38、ntended to help ensure the delivery of products with consistent properties for subsequent processing and/or final product performance. This Technical Specification includes guidance on specifying the physical and chemical characteristics of manufactured nano-objects, which might affect performance o
39、r subsequent processing. A list of applicable measurement methods is given in Annex B. NOTE 1 The nano-objects can be supplied in a dry form or as dispersions in a liquid medium. Guidance on specifying the environmental, health and safety (EHS) characteristics of manufactured nano-objects is outside
40、 the scope of this Technical Specification. NOTE 2 Nanotechnology is a rapidly growing and evolving field. It is therefore good practice for users of this Technical Specification to maintain an awareness of the legislative environment and latest developments in EHS regarding nanotechnology (see Refe
41、rences 12341516383940414243). If the customer or supplier wishes to assess the environmental, safety or health risks of the material, they can refer to ISO/TR 13121 and ISO/TR 12885for further guidance. This Technical Specification also does not include guidance on specifying materials containing na
42、nosized phases formed in situ by a transformation in the material, e.g. Guinier-Preston zones in precipitation hardening metals. Furthermore, it does not specify quantitative requirements for the object to be considered a nano-object, but lists appropriate examples of characteristics and properties
43、and their measurement methods useful for specifying nano-objects. Characteristics and measurement methods for nano devices are not included. Although this Technical Specification refers to parameters, which could be considered aspects of material quality, it is not intended to provide guidance on th
44、e establishment of quality management systems. For guidance on quality management systems, reference can be made to ISO 9000. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For un
45、dated references, 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/TS 80004-1, Nanotechnologies Vocabulary Part 1: Core terms DD ISO/TS 12805:2011ISO
46、/TS 12805:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/TS 27687, ISO/TS 80004-1 and the following apply. 3.1 nano-object material with one, two or three external dimensions in the nanoscale 3.2 nanoscale size
47、range from approximately 1 nm to 100 nm 3.3 manufactured nano-object nano-object intentionally produced for commercial purposes to have specific properties or composition 4 Specifying manufactured nano-objects 4.1 General Product specifications are an important component of the information a supplie
48、r provides to the marketplace, which also includes items such as trade names, product grades, product information sheets, material safety data sheets, case histories, testimonials and advertising. For the supplier, product specifications reflect production capabilities and are used to differentiate
49、product grades. For the customer, product specifications are used to differentiate among alternative suppliers or materials. They are used to set specifications for the end-use product. For both supplier and customer, product specifications are used in firm-wide quality systems such as ISO 9001 to ensure consistent manufacture. They form the basis for commercial activities such as complaint resolution, product recall, guarantees and warranties. There are instances where nano-objects can fa
