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  • DIN EN ISO 14155-2:2003-09

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  01-01-2012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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    Table of Contents - (Show below) - (Hide below)

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

    Abstract - (Show below) - (Hide below)

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

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

    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    Status Superseded

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

    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
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