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  • 14/30296035 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-07-2017

    Language(s):  English

    Published date: 

    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 Risk assessment
    5 Pilot clinical studies
    6 Clinical validation investigation
    Annex A (informative) - Formula for Power Calculation
    Annex B (informative) - Pilot Clinical Investigation
    Annex C (informative) - Time and Events Schedule for individual
            study subject (sample)
    Annex D (informative) - Study Entry, data collection form
    Annex E (informative) -Mid-study, data collection form
    Annex F (informative) - Single Use of Female Condom, data
            collection form
    Annex G (informative) - Advert reaction report form (sample)
    Annex H (informative) - Protocol for Evaluation of Returned
            Used Condoms
    Bibliography

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

    Comment Closes On
    Committee CH/157
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 25841:2017 Female condoms — Requirements and test methods
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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