BS ISO 23409:2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Biocompatibility
7 Product claims
8 Design
9 Preclinical evaluation
10 Clinical (human use) investigations
11 Bursting volume and pressure
12 Freedom from holes
13 Stability and shelf-life
14 Visible defects
15 Package integrity for individual container
16 Packaging and labelling
17 Data sheet and test report
Annex A (normative) - Sampling plans intended for assessing
        compliance of a continuing series of lots with
        sufficient number to allow the switching rules
        to be applied
Annex B (informative) - Sampling plans that are intended
        for assessing the 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 barrier properties
        using the bacteriophage method
Annex H (normative) - Determination of the bursting volume
        and pressure
Annex I (informative) - Calibration of air inflation
        equipment for determination of burst volume
        volume and pressure
Annex J (normative) - Testing for holes
Annex K (normative) - Determination of shelf-life by
        real-time stability tests
Annex L (informative) - Guidance on conducting and
        analysing ageing studies
Annex M (normative) - Tests for individual container
        integrity
Annex N (informative) - Oven treatment for condoms made
        from synthetic materials
Bibliography

Describes the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.

This International Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.