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  • AAMI ISO 14155 : 2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  20-01-2021

    Language(s): 

    Published date:  30-12-2010

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of ISO 14155:2011
    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Ethical considerations
    5 Clinical investigation planning
    6 Clinical investigation conduct
    7 Suspension, termination and close-out of the clinical
      investigation
    8 Responsibilities of the sponsor
    9 Responsibilities of the principal investigator
    Annex A (normative) - Clinical investigation plan (CIP)
    Annex B (normative) - Investigator's brochure (IB)
    Annex C (informative) - Case report forms (CRFs)
    Annex D (informative) - Clinical investigation report
    Annex E (informative) - Essential clinical investigation
                            documents
    Annex F (informative) - Adverse event categorization
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

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

    Committee WG 04
    Development Note Supersedes AAMI ISO 14155-1 and AAMI ISO 14155-2. (03/2011)
    Document Type Standard
    Product Note NEW CHILD ERR 1 IS NOW ADDED.
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    MEDDEV 2.12-1 : REV 8 : 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
    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
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