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  • 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, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  03-02-2011

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 23409:2011 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)

    Development Note Supersedes ISO/DIS 23409. (02/2011)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    15/30302532 DC : 0 BS ISO 19671 - ADDITIONAL LUBRICANTS FOR CONDOMS - EFFECT ON CONDOM STRENGTH
    ISO 29943-1:2017 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
    BS ISO 29943-1:2017 Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports
    ASTM D 6324 : 2011 Standard Test Methods for Male Condoms Made from Polyurethane
    ISO 16038:2017 Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
    16/30346829 DC : 0 BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
    14/30296392 DC : 0 BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
    BS ISO 16038:2017 Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
    ASTM D 6324 : 2011 : R2017 Standard Specification for Male Condoms Made from Polyurethane

    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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