Male condoms. Requirements and test methods for condoms made from synthetic materials

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-31-2011

Publisher

British Standards Institution

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.

Committee	CH/157
DevelopmentNote	Supersedes 08/30133979 DC. (03/2011)
DocumentType	Standard
Pages	56
PublisherName	British Standards Institution
Status	Current
Supersedes	08/30133979 DC : DRAFT MAY 2008

Standards	Relationship
ISO 23409:2011	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 11346:2014	Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use
2007/47/EC : 2007 COR 1 2015	DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 188:2011	Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2230:2002	Rubber products — Guidelines for storage
ISO 16038:2005	Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
ISO 16037:2002	Rubber condoms for clinical trials Measurement of physical properties
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 9004:2009	Managing for the sustained success of an organization A quality management approach
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 4074:2015	Natural rubber latex male condoms Requirements and test methods
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 29943-1:2017	Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 980:2008	Symbols for use in the labelling of medical devices
ISO/IEC Guide 7:1994	Guidelines for drafting of standards suitable for use for conformity assessment

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BS ISO 23409:2011

Male condoms. Requirements and test methods for condoms made from synthetic materials

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory