BS PD ISO TS 19337-2016 Nanotechnologies Characteristics of working suspensions of nano-objects for $ii$in $iv$ii$it$ir$io assays to evaluate inherent nano-object toxi city《纳米技术 评估.pdf
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1、BSI Standards PublicationPD ISO/TS 19337:2016Nanotechnologies Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicityPD ISO/TS 19337:2016 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of ISO/TS 19337:2
2、016.The UK participation in its preparation was entrusted to Technical Committee 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 ar
3、e responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 90824 8 ICS 07.030 Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the
4、 Standards Policy and Strategy Committee on 30 April 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dPD ISO/TS 19337:2016 ISO 2016Nanotechnologies Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicityNanote
5、chnologies Caracteristiques des suspensions de nano-objets utilises pour les tests in vitro valuant la toxicit inherente aux nano-objetsTECHNICAL SPECIFICATIONISO/TS19337Reference numberISO/TS 19337:2016(E)First edition2016-03-15PD ISO/TS 19337:2016ISO/TS 19337:2016(E)ii ISO 2016 All rights reserved
6、COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet
7、, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.
8、orgPD ISO/TS 19337:2016ISO/TS 19337:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviated terms 25 Characteristics and measurement methods 25.1 General . 25.2 Endotoxin . 25.3 Stability of working suspensions 25.3.1 General 25.3.2 Representative
9、size change of secondary particles of nano-objects . 35.3.3 Concentration change of nano-objects . 35.4 Concentration of metal ions. 35.5 Concentration of culture medium components 35.5.1 General 35.5.2 Proteins 45.5.3 Calcium . 46 Reporting 46.1 General . 46.2 Name of nano-objects and manufacturer
10、46.3 Metallic elements included in the nano-object sample 46.4 Culture medium and serum . 46.5 Measurement results . 46.6 Deviation 5Annex A (informative) Flow of measurements. 6Annex B (informative) Measurement and evaluation of stability 7Annex C (informative) Measurement of metal ions. 8Annex D (
11、informative) Measurement of culture medium components 9Bibliography .10 ISO 2016 All rights reserved iiiContents PagePD ISO/TS 19337:2016ISO/TS 19337:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). Th
12、e 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 represented on that committee. International organizations, governmental and non-gov
13、ernmental, 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.The procedures used to develop this document and those intended for its further maintenance are described i
14、n the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the
15、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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO li
16、st of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as wel
17、l as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 229, Nanotechnologies.iv ISO 2016 All rights reservedPD ISO/TS 19337:2016ISO/TS 19337:
18、2016(E)IntroductionBefore nano-objects enter into the market, their possible impact on human health and the environment needs to be carefully evaluated.In vitro toxicity assays using cultured cells are frequently used as a tool in screening hazardous materials. This testing provides essential inform
19、ation for understanding the mechanisms of biological effects induced by the materials. However, nano-objects require specific considerations with respect to the in vitro toxicity assays, because their behaviour is distinct from water soluble chemicals. For example, immediately after the introduction
20、 of nano-object samples into the culture medium, the nano-objects undergo changes, such as (a) dissolution, which is the dissolving of nano-objects into their ionic counterparts, (b) corona formation, which is the adsorption of the components of culture medium onto the nano-object surface, or (c) ch
21、anges in aggregation/agglomeration state, leading to alteration in particles size and sedimentation. Therefore, it is critical to consider the aforementioned phenomena in clarifying if the observed effects are related to the tested nano-object itself or from other uncontrolled sources and to avoid f
22、alse interpretation of assay results.The rigorous characterization of the working suspension prior and during in vitro toxicity assays is essential to exclude the in vitro experimental artefacts. For example, the corona formation, metal ion release from the nano-objects and impurities (residual from
23、 the nano-object synthesis process) can interfere with some in vitro assays,1producing inaccurate results. Additionally, the formation of agglomerates and aggregates can alter the toxicity of a suspension. Therefore, it is important to carefully assess and describe the characteristics of the suspens
24、ion of nano-objects being tested.This Technical Specification describes the essential characteristics and applicable measurement methods of working suspension containing nano-object samples for in vitro toxicity assays. Intention is that reliable test results on nano-object toxicity could be shared
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