ISO INTERNATIONAL STANDARD 29701 First edition 2010-09-15 Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test Nanotechnologies Essai de détection d'endotoxines sur des échantillons de nanomatériaux pour des systemes in vitro - Essai au lysat d'amebocyte de Limule (LAL) Reference number ISO 29701:2010(E) @ ISO 2010 ISO 29701:2010(E) PDFdisclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The Iso Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation COPYRIGHTPROTECTEDDOCUMENT ? ISO2010 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, including photocopying and microfilm, without permission in writing from either isO at the address below or IsO's 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 copyright@iso.org Web www.iso.org Published in Switzerland ISO2010-All rightsreserved ISO29701:2010(E) Contents Page Foreword .iv Introductior 1 Scope 2 Terms and definitions 3 Abbreviatedterms 4 Pre-testconsiderations 4.1 Storage of nanomaterials ... 4.2 Storage containers. 4.3 Handling of nanomaterials 5 Test sample. 5.1 Aqueousdispersion 5.2 Aqueous extract 6 Preparation of test sample, 6.1 Dispersion method. 6.2 Extractionmethod. 6.3 Concentration .... 6.4 Storage of test sample . 6.5 Laboratory environment . 7 Test methods 7.1 Principle..... 7.2 Alternative test methods... 7.3 Selection and validation of the test method 7.4 Test procedures... 8 Assessment of results 8.1 8.2 Guidance on application of test. 9 Test report. Annex A (informative) Examples of potential interferences to LAL test. AnnexB(informative)Gel-clotmethod, .9 Annex C (informative) Endpoint photometric method ... Annex D (informative) Kinetic method. 16 Bibliography.. alion'ghts reserved ili