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  • AAMI/IEC TIR80002-1:2009

    Current The latest, up-to-date edition.

    MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  26-10-2009

    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 AAMI adoption of IEC TIR8002-1:2009
    FOREWORD
    INTRODUCTION
    1 General
    2 Terms and definitions
    3 General requirements for RISK MANAGEMENT
    4 RISK ANALYSIS
    5 RISK EVALUATION
    6 RISK CONTROL
    7 Evaluation of overall residual risk acceptability
    8 Risk management report
    9 Production and POST-PRODUCTION information
    Annex A (informative) - Discussion of definitions
    Annex B (informative) - Examples of software causes
    Annex C (informative) - Potential software-related pitfalls
    Annex D (informative) - Life-cycle/risk management grid
    Annex E (informative) - SAFETY cases
    Bibliography
    Index
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Specifies guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software - Software life cycle processes.

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

    Committee SW
    Document Type Technical Report
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS

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

    IEC 61025:2006 Fault tree analysis (FTA)
    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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