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ISO 29942 : 2011

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ISO 29942 : 2011

PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS

International Organization for Standardization

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Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Design
6 Barrier properties
7 Biocompatibility
8 Surface finish
9 Tensile properties
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 (normative) - Sampling plans intended for assessing
                      compliance of isolated lots
Annex C (normative) - Determination of length and width
Annex D (normative) - Determination of dam thickness
Annex E (informative) - Guidance for risk assessment
Annex F (normative) - Determination of barrier properties
                      using the bacteriophage method
Annex G (normative) - Determination of tensile properties
Annex H (normative) - Oven conditioning
Annex I (normative) - Determination of shelf-life by real-time
                      stability studies
Annex J (informative) - Guidance on conducting and analysing
                        accelerated ageing studies
Annex K (normative) - Testing for holes
Bibliography

Abstract

Describes the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 157
Supersedes
  • ISO/DIS 29942 : 60.00 (JUN 2011)