Foreword
Introduction
1 Scope
2 Normative references
2 Terms and definitions
3 Quality verification
4 Lot size
5 Biocompatibility
6 Microbial contamination
7 Product claims
8 Design
9 Bursting volume and pressure
10 Stability and shelf life
11 Freedom from holes
12 Visible defects
13 Package integrity of individual container
14 Packaging and labelling
15 Test report
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 total lubricant
for condoms in individual containers
Annex D (normative) - Determination of length
Annex E (normative) - Method for the determination of
width
Annex F (normative) - Determination of thickness
Annex G (informative) - Determination of microbial
contamination
Annex H (normative) - Determination of bursting volume
and pressure
Annex I (normative) - Oven treatment for condoms
Annex J (informative) - Determination of force and elongation
at break of test pieces of condoms
Annex K (normative) - Determination of shelf life by real-time
stability studies
Annex L (informative) - Guidance on conducting and
analysing accelerated ageing studies
Annex M (normative) - Testing for holes
Annex N (normative) - Testing for package integrity
Annex O (informative) - Calibration of air inflation
equipment for determination of bursting
volume and pressure
Annex P (informative) - Recommendations for testing
condoms that fall outside of the size ranges
specified in ISO 4074
Bibliography
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directives 93/42/EEC