ISO INTERNATIONAL STANDARD 4074 Third edition 2015-10-15 Natural rubber latex male condoms Reguirements and test methods Préservatifs masculins en latex de caoutchouc naturel - Exigences et méthodes d'essai Reference number ISO 4074:2015(E) ISO International Organization for Standardization isee=Zhejang Institute of Standardization 5956617 @IS02015 vided by IHS under No reproduction or networking permitted without license from IHS IS0 4074:2015(E) COPYRIGHT PROTECTED DOCUMENT IS0 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISOcopyrightoffice 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 Internatinir DrganizationforStandardization Not for Resale, 2015/11/30 07:18:29 networking permited withoutlicense from IHS IS0 4074:2015(E) Contents Page Foreword ..V Introduction. ..vii 1 Scope. 2 Normative references 3 Terms and definitions 4 Quality verification ..3 5 Lot size 3 6 Biocompatibility ..4 7 Microbial contamination. ..4 8 Product claims ..4 9 Design ..4 9.1 Integral bead. .4 9.2 Lubrication 4 9.3 Dimensions ..5 9.3.1 Length .5 9.3.2 Width .5 9.3.3 Thickness. ..5 10 Bursting volume and pressure .5 11 Stability and shelf life ..6 11.1 General ..6 11.2 Minimum stability requirements ..6 11.3 Procedure for determining shelf life by real-time stability studies .7 11.4 Estimating shelf life based upon accelerated stability studies ..7 12 Freedom from holes ..7 13 Visible defects. 14 Package integrity of individual container. .8 15 Packaging and labelling ..8 15.1 Packaging. ..8 15.2 Labelling ..8 15.2.1 General. ..8 15.2.2 Symbols. ..8 15.2.3 Individual container. .8 15.2.4 Consumer package .9 15.2.5 Condoms not distributed in consumer packages .11 15.3 Inspection. ..11 16 Test report ..11 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 ..12 Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .14 Annex C (normative) Determination of total lubricant for condoms in individual containers ...16 Annex D (normative) Determination of length ..20 Annex E (normative) Determination of width ..22 Annex F (normative) Determination of thickness ..23 Annex G (informative) Determination of microbial contamination ..26 iii Licensee=Zhejiang Institute of Standardization 5956617 without license from IHS Not for Resale, 2015/11/30 07:18:29