European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Biocompatibility
7 Microbial contamination
8 Product claims
9 Design
10 Bursting volume and pressure
11 Stability and shelf life
12 Freedom from holes
13 Visible defects
14 Package integrity of individual container
15 Packaging and labelling
16 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) - 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
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices