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  • DIN EN ISO 14155-2:2009-11

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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    Superseded date:  01-01-2012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:  01-01-2009

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

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    Table of Contents - (Show below) - (Hide below)

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Anforderungen
    Anhang A (informativ) Prüfbogen (CRF)
    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen
              dieser Europäischen Norm und den
              grundlegenden Anforderungen der EG-Richtlinie
              93/42/EWG über Medizinprodukte
    Anhang ZB (informativ) Zusammenhang zwischen
              dieser Europäischen Norm und den
              grundlegenden Anforderungen der EG-Richtlinie
              90/385/EWG über aktive implantierbare
              Medizinprodukte

    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 Supersedes DIN EN 540. (10/2003)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    DIN EN ISO 22794:2009-11 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
    DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
    DIN EN ISO 14607:2009-08 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
    DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

    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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