• AAMI/IEC TIR80002-3:2016

    Current The latest, up-to-date edition.

    MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  12-08-2016

    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/IEC TIR80002-3:2016
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Medical device software life cycle processes
    Annex A (informative) - Development of this
            technical report
    Annex B (informative) - Mapping between IEC
            62304:2006 and ISO/IEC 12207:2008
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of IEC 80002, which is a technical report (TR), provides the description of software life cycle processes for medical devices.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    ISO/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/IEC 15288:2008 Systems and software engineering System life cycle processes
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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