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  • DIN EN ISO 14155-2 E : 2003

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-01-2012

    Language(s):  English

    Published date:  01-01-2003

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Requirements<br>Annex A (informative) - Case Report Forms<br>Bibliography<br>Annex ZA (informative) Relationship between this European Standard<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and the Essential Requirements of EU Directive 93/42/EEC<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;on Medical Devices<br>Annex ZB (informative) Relationship between this European Standard<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and the Essential Requirements of EU Directive 90/385/EEC<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;on Active Implantable Medical Devices

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    Specifies requirements for the preparation of a Clinical Investigation Plan (CIP) for clinical investigation of medical devices.

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    Development Note Together with DIN EN ISO 14155-1 E supersedes DIN EN 540 E. (02/2004)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Supersedes

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

    DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    DIN EN ISO 21649:2010-01 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
    DIN EN ISO 21649 E : 2010 NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 10993-10:2003-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
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