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  • DIN EN ISO 14155-1:2009-11

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: GENERAL REQUIREMENTS

    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    Superseded date:  01-01-2012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 Begründung der klinischen Prüfung
    5 Ethische Erwägungen
    6 Allgemeine Anforderungen
    7 Dokumentation
    8 Sponsor
    9 Monitor
    10 Klinischer Prüfer
    11 Schlussbericht
    Anhang A (informativ) Vorgeschlagenes Verfahren
              für den Literaturnachweis
    Anhang B (informativ) Informationen für die
              Ethikkommissionen
    Anhang C (informativ) Schlussberichte für klinische
              Prüfungen von Medizinprodukten
    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 procedures for the conduct and performance of clinical investigations of medical devices. Applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

    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    Status Superseded
    Superseded By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 22803:2006-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
    VDI 3823 Blatt 4:2006-11 Vacuum coating quality assurance - Testing of vacuum coated plastics
    DIN EN ISO 21534:2009-08 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
    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 7439:2015-08 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
    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)
    DIN EN ISO 5840:2009-08 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

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

    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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