ISO INTERNATIONAL STANDARD 23409 First edition 2011-02-15 Male condoms Reguirements and test methods for condoms made from synthetic materials Préservatifs masculins-Exigences et methodes d'essai pour les préservatifs fabriqués en matieres synthetiques Reference number ISO 23409:2011(E) @ ISO 2011 yIHS under Not for Resale ISO23409:2011(E) PDF disclaimer 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 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 parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below 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, 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 [email protected] Web www.iso.org Published in Switzerland @IsO 2011-All rights reserved without license from IHS Not for Resale ISO 23409:2011(E) Contents Page Foreword iv Introduction. 1 Scope 2 Normative references. 3 Terms and definitions . 4 Quality verification ... 5 Lot size 6 Biocompatibility... 7 Product claims 8 Design. 9 Preclinical evaluation. 10 Clinical (human use) investigations ... 6 11 Bursting volume and pressure 12 Freedom from holes... 13 Stability and shelf-life . 14 Visible defects 8 15 Package integrity for individual container... .8 16 Packaging and labelling... 8 17 Data sheet and test report . Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of lots with sufficient number to allow the switching rules to be applied ..... Annex B (informative) Sampling plans that are intended for assessing the compliance of isolated lots...... Annex C (normative) Determination of total lubricant for condoms in individual containers... Annex D (normative) Determination of length ... .16 Annex E (normative) Determination of width... 18 Annex F (normative) Determination of thickness... Annex G (informative) Determination of barrier properties using the bacteriophage method..... Annex H (normative) Determination of the bursting volume and pressure... Annex I (informative) Calibration of air inflation equipment for determination of burst volume and pressure ......... 27 Annex J (normative) Testing for holes .... Annex K (normative) Determination of shelf-life by real-time stability tests... Annex L (informative) Guidance on conducting and analysing ageing studies , ...38 Annex M (normative) Tests for individual container integrity.... ..40 Annex N (informative) Oven treatment for condoms made from synthetic materials ... .42 Bibliography. ii Copyright Interna from IHS Not for Resal