ISO/TR TECHNICAL REPORT 22293 First edition 2021-07 Evaluation of methods for assessing the release of nanomaterials from commercial, nanomaterial-containing polymer composites Evaluation des méthodes de détermination d'émission de nanomateriaux par des polymeres composites commerciaux, contenant des nanomatériaux Reference number IS0/TR22293:2021(E) ISO IS02021 IS0/TR 22293:2021(E) COPYRIGHT PROTECTED DOCUMENT @ iS0 2021 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2021 - All rights reserved IS0/TR 22293:2021(E) Contents Page Foreword .V Introduction. ..vi 1 Scope. .1 2 Normative references. 3 Terms and definitions 1 4 Abbreviations. .3 5 Understanding the nano-enabled products .4 5.1 Pathway analysis for the supply chain. 4 5.2 Matrix and MNM characteristics affecting rate and form of release. .8 5.2.1 General. .8 5.2.2 Consideration of the polymer used in the composite .9 5.2.3 Polymer degradation .10 5.2.4 Consideration of MNM used in the composite 10 5.2.5 Polymer nanocomposites 11 5.2.6 Application areas and use phase (or lifecycle) processes. 12 6 Factors affecting release measurement method selection .15 6.1 General .15 6.2 Forms of release. .16 6.3 Decision support framework to determine which transformations need consideration with examples .21 7 Approaches to detecting and quantifying the released material associated with added manufactured nanomaterials 23 7.1 General 23 7.2 Methods for sampling released material 23 7.2.1 General. 23 7.2.2 Sampling material released into air 24 7.2.3 Sampling material released into water, solids, and biological fluids 25 7.3 Methods for preparing samples of released material for subseguent analysis 26 7.3.1 General. 26 7.3.2 Preparation and analysis of air samples 26 7.3.3 Preparation and analysis of waters, solids and biological fluid samples 27 7.4 Measurement challenges. 28 7.4.1 General 28 7.4.2 Surface functionalization and transformations. 28 7.4.3 Samplecollectionartefacts 29 7.4.4 Applicability of a measurement method for a given release media. 29 7.4.5 Sample preparation artefacts. 29 7.4.6 Capability of a measurement method. 29 7.4.7 Representativenessofmeasurements 30 7.4.8 Composition measurements.. 30 7.4.9 Polymer stability 30 7.4.10 Commercial practices .30 7.5 Considerations for detection, quantification, and determination of properties of releasedmaterials. .31 7.6 Applicable measurement methods. .32 8 Identification of needs for standards, methods, instrumentation, decision frameworks, and research. 32 8.1 General 32 8.2 Potential improved/new methods 32 8.3 Inter-laboratory studies. 33 8.4 Protocols and assays. .34 @ IS0 2021 - All rights reserved iii IS0/TR 22293:2021(E) 8.5 Opportunities for standardization of methods .34 8.6 Decision frameworks ..35 Annex A (informative) Example case studies ..38 Bibliography ..57 iv @ IS0 2021 - All rights reserved IS0/TR 22293:2021(E) Foreword 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 throughIsotechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnica. 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 E