Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Design
7 Barrier properties
8 Biocompatibility
9 Clinical (human use) investigations
10 Microbial contamination
11 Bursting volume and pressure
12 Tests for stability and shelf life
13 Freedom from holes
14 Visible defects
15 Packaging and labelling
16 Data sheets
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
Annex B (informative) - Sampling plans intended for
        assessing conformity of isolated lots
Annex C (normative) - Determination of lubricant mass
        for individual female condom containers
Annex D (normative) - Determination of female condom
        length
Annex E (normative) - Determination of female condom
        width
Annex F (normative) - Determination of female condom
        thickness
Annex G (normative) - Testing for female condom individual
        container integrity
Annex H (normative) - Determination of barrier properties
        using the bacteriophage method
Annex I (informative) - Determination of microbial contamination
Annex J (normative) - Determination of bursting volume and
        bursting pressure
Annex K (normative) - Testing for holes
Annex L (normative) - Determination of shelf life by real-time
        stability studies
Annex M (informative) - Guidance on conducting and analysing
        accelerated ageing studies
Bibliography

Abstract

This document specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 157
Supersedes	ISO/DIS 25841 : 60.00 (2017) ISO 25841 : 2014