Skip to content
Please enter a keyword to search

  • DIN EN ISO 14155:2012-01

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-12-2020

    Language(s):  German, English

    Published date:  01-01-2012

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

    Add To Cart

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

    Vorwort
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Ethische Erwägungen
    5 Planung der klinischen Prüfung
    6 Durchführung der Prüfung
    7 Aussetzung, Beendigung und Abbruch
      der klinische Prüfung
    8 Verantwortlichkeiten des Sponsors
    9 Verantwortung des Prüfleiters
    Anhang A (normativ) Klinischer Prüfplan (CIP)
    Anhang B (normativ) Prüferbroschüre (IB)
    Anhang C (informativ) Prüfbögen (CRF)
    Anhang D (informativ) Klinischer Prüfbericht
    Anhang E (informativ) Wesentliche Dokumente der
              klinischen Prüfung
    Anhang F (informativ) Entscheidungsbaum für die
              Klassifizierung von unerwünschten Ereignissen
    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
    Literaturhinweise
    Tabellen
    Bilder

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN HDBK 268.

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

    Development Note Supersedes DIN EN ISO 14155-1 and DIN EN ISO 14155-2. (01/2012)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
    VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
    DIN EN ISO 11979-7:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
    DIN EN ISO 11979-10:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
    DIN EN ISO 11979-9:2014-12 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    DIN EN ISO 81060-2:2014-10 NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVASTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013)
    DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    DIN EN ISO 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
    DIN EN ISO 13504:2012-10 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
    DIN EN ISO 7198:2017-07 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    DIN EN ISO 10079-1:2016-05 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    DIN EN ISO 10079-2:2014-09 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
    DIN EN ISO 11979-8:2016-04 (Draft) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
    DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    DIN HDBK 268 : 3ED 2015 NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN

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

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective