Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Barrier properties
6 Biocompatibility
7 Clinical (human use) investigations
8 Microbial contamination
9 Bursting volume and pressure
10 Tests for stability and shelf-life
11 Freedom from holes
12 Visible defects
13 Packaging and labelling
14 Data sheets
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
Annex B (informative) - Sampling plans intended for
assessing compliance 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