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  • AAMI/ISO TIR 80002-2:2017

    Current The latest, up-to-date edition.

    MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  18-08-2017

    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 ISO TR 80002-2
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Software validation discussion
    5 Software validation and critical thinking
    6 Documentation
    7 Prerequisite processes
    Annex A (informative) - Toolbox
    Annex B (informative) - Risk management
            and risk-based approach
    Annex C (informative) - Examples
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

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

    Committee ISO/TC 210
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    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 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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