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  • ISO 25841:2017

    Current The latest, up-to-date edition.

    Female condoms — Requirements and test methods

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  14-08-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 25841:2017 specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).

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

    Committee ISO/TC 157
    Development Note Supersedes ISO/DIS 25841. (08/2017) NEW CHILD AMD 1 IS ADDED
    Document Type Standard
    Product Note NEW CHILD AMD 1 IS ADDED
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    14/30296035 DC : 0 BS ISO 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
    ISO 29943-2:2017 Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
    BS ISO 29943-2:2017 Condoms. Guidance on clinical studies Female condoms, clinical function studies based on self-reports

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

    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 11346:2014 Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    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/IEC 17007:2009 Conformity assessment — Guidance for drafting normative documents suitable for use for conformity assessment
    ISO/TR 8550-1:2007 Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 1: Acceptance sampling
    ISO/TR 8550-2:2007 Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 2: Sampling by attributes
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 29943-2:2017 Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
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