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  • 14/30296392 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE 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    Superseded date:  31-07-2017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 Pilot clinical studies
    5 Clinical validation investigation
    Annex A (informative) - Formula for power calculation
    Annex B (informative) - Pilot clinical investigation
            (sample outline)
    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) - Individual condom use, data
            collection form
    Annex G (informative) - Adverse 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    Status Superseded
    Superseded By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 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
    ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
    ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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