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  • BS ISO 23409:2011

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2011

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/157
    Development Note Supersedes 08/30133979 DC. (03/2011)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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