Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Quality verification<br>5 Lot size<br>6 Biocompatibility<br>7 Microbial contamination<br>8 Product claims<br>9 Design<br>10 Bursting volume and pressure<br>11 Stability and shelf life<br>12 Freedom from holes<br>13 Visible defects<br>14 Package integrity of individual container<br>15 Packaging and labelling<br>16 Test report<br>Annex A (normative) - Sampling plans intended for assessing<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;compliance of a continuing series of lots of sufficient<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;number to allow the switching rules to be applied<br>Annex B (informative) - Sampling plans intended for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;assessing compliance of isolated lots<br>Annex C (normative) - Determination of total lubricant<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for condoms in individual containers<br>Annex D (normative) - Determination of length<br>Annex E (normative) - Determination of width<br>Annex F (normative) - Determination of thickness<br>Annex G (informative) - Determination of microbial<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination<br>Annex H (normative) - Determination of bursting<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;volume and pressure<br>Annex I (normative) - Oven treatment for condoms<br>Annex J (informative) - Determination of force and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;elongation at break of test pieces of condoms<br>Annex K (normative) - Determination of shelf life by<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;real-time stability studies<br>Annex L (informative) - Guidance on conducting and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;analysing accelerated ageing studies<br>Annex M (normative) - Testing for holes<br>Annex N (normative) - Testing for package integrity<br>Annex O (informative) - Calibration of air inflation<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;equipment for determination of bursting volume<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and pressure<br>Annex P (informative) - Recommendations for testing<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;condoms that fall outside of the size<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ranges specified in ISO 4074<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential Requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of EU Directive 93/42/EEC on Medical Devices

Abstract

Defines requirements and test methods for male condoms made from natural rubber latex.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/157
Supersedes	99/565033 DC : SEP 99 BS 3704(1996) : 1996 12/30251858 DC : 0