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  • BS ISO 25841:2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Female condoms. Requirements and test methods

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-04-2020

    Language(s):  English

    Published date:  18-09-2017

    Publisher:  British Standards Institution

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

    Committee CH/157
    Development Note Supersedes 15/30303073 DC. (10/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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