BS IS0 25841:2017 BSl Standards Publication Female condoms - Reguirements and test methods bsi. British Standards Institutior DEMYOFSTANDARDIZATION 9972181 BSISO25841:2017 BRITISH STANDARD National foreword This British Standard is the UK implementation of IS0 25841:2017. It supersedes BS IS0 25841:2014 , which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/157, Mechanical contraceptives. 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 are responsible for its correct application. @ The British Standards Institution 2017 Published by BSI Standards Limited 2017 ISBN 978 0 580 87018 7 ICS 11.200 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017. Amendments/corrigenda issued since publication Date Text affected British Standards Institution nsee=SHENZHEN ACADEMY OF STANDARDIZATION 9972181 Not for Resale, 2017/11/30 07:46:02 BSIS0 25841:2017 INTERNATIONAL ISO STANDARD 25841 Third edition 2017-08-15 Female condoms Requirements and test methods Preservatifs féminins - Exigences et méthodes d'essai Reference number ISO 25841:2017(E) ISO British Standards Instution ISee=SHENZHEN ACADEMY OF STANDARDIZATION 9972181 @ IS0 2017 Not for Resale, 2017/11/30 07:46:02 BSISO 25841:2017 IS0 25841:2017(E) COPYRIGHT PROTECTEDDOCUMENT IS0 2017, Published in Switzerland All 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, 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 Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Licensee-SHENZHEN ACADEMY OF STANDDISAioNggZis, All rights reserved Not for Resale, 2017/11/30 07:46:02 No reproduction BS ISO 25841:2017 IS0 25841:2017(E) Contents Page Foreword ..V Introduction. ..vii 1 Scope. 2 Normative references 3 Terms and definitions 3.1 General terms.. .2 3.2 Terms related to female condom failure modes 4 Quality verification ..5 5 Lot size ..6 6 Design .6 6.1 General .6 6.2 Product insertion feature 6.3 Retention features. .7 6.4 Lubrication 6.5 Dimensions. .8 6.5.1 Length ..8 6.5.2 Width ..8 6.5.3 Thickness. ..8 6.6 Risk assessment. .9 7 Barrier properties ..9 8 Biocompatibility ..9 9 Clinical (human use) investigations ..10 10 Microbial contamination ..11 11 Bursting volume and pressure ..11 11.1 Minimum values. ..11 11.2 Sampling and requirements ..12 12 Tests for stability and shelf life ..12 12.1 General... ..12 12.2 Procedure for determining shelf life by real-time stability studies .12 12.3 Procedure for estimating shelf life based upon accelerated stability studies .13 13 Freedom from holes ..13 14 Visible defects. ..13 15 Packaging and labelling. ..13 15.1 Individual container integrity ..13 15.2 Packaging. ..13 15.3 Labelling .14 15.3.1 Symbols. .14 15.3.2 Individual containers. .14 15.3.3 Consumer packages. ..14 15.3.4 Additional information for the consumer .15 15.3.5 Female condoms not distributed in consumer packages. .16 15.4 Inspection. ..16 16 Data sheets. ..17 Annex A (normative) Sampling plans intended for assessing conformity of a continuing series of lots of sufficient number to allow the switching rules to be applied .18 Annex B (informative) Sampling plans intended for assessing conformity of isolated lots. ..19 iii icensee=SHENZHEN ACADEMY OF STANDARDIZATION 9972181 Not for Resale, 2017/11/30 07:46:02 BS ISO 25841:2017 IS0 25841:2017(E) Contents