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ISO 4074 : 2015

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ISO 4074 : 2015

NATURAL RUBBER LATEX MALE CONDOMS - 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 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

Abstract

This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
ProductNote THIS STANDARD ALSO REFERS- ISO/TR 8550 (all parts),ISO 2859-1
Committee TC 157
Supersedes
  • ISO 4074-5 : 1996
  • ISO 4074-9 : 1996
  • ISO 4074-1 : 1996
  • ISO 4074-7 : 1996
  • ISO 4074-2 : 1994
  • ISO 4074-3 : 1994
  • ISO/FDIS 4074 : 60.00 (2015)
  • ISO 4074-10 : 1990
  • ISO 4074-8 : 1984
  • ISO 4074-6 : 1996
  • ISO 4074-4 : 1980