ISO INTERNATIONAL STANDARD 29942 First edition 2011-07-01 Prophylactic dams Requirements and test methods Membranes prophylactiques Exigences et methodes d'essai Reference number ISO 29942:2011(E) @ ISO 2011 by IHS under lic Not for Resale ISO 29942:2011(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, 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 [email protected] Web:www.iso.org Published in Switzerland @ ISO 2011 - All rights reserved by IHS under etworking pemitted without licensefromHS Not for Resale ISO 29942:2011(E) Contents Page Foreword Introductior 1 Scope 2 Normative references 3 Terms and definitions 4 Quality verification 5 Design 6 Barrier properties 7 Biocompatibility.. 8 Surface finish.. 9 Tensile properties. 10 Tests for stability and shelf-life 11 Freedom from holes.. 12 Visible defects . 13 Packaging and labelling... 14 Data sheets .. Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of lots of sufficient number to allow the switching rules to be applied... .11 Annex B (normative) Sampling plans intended for assessing compliance of isolated lots .. .12 AnnexC(normative)Determinationoflengthandwidth... ....13 Annex D (normative) Determination of dam thickness. .14 Annex E (informative) Guidance for risk assessment.. Annex F (normative) Determination of barrier properties using the bacteriophage method... Annex G (normative) Determination of tensile properties.. ..21 Annex H (normative) Oven conditioning ... .22 Annex I (normative) Determination of shelf-life by real-time stability studies .23 Annex J (informative) Guidance on conducting and analysing accelerated ageing studies.. .25 Annex K (normative) Testing for holes Bibliography 29 Copyrght International OrganizaionStandardizaonghts reserved ii se from IHS Not for Re