• AAMI TIR32 : 2004 : R2016

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL DEVICE SOFTWARE RISK MANAGEMENT

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  01-11-2017

    Language(s):  English

    Published date:  01-01-2016

    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
    Foreword
    Introduction
    1 Scope
    2 References
    3 Definitions
    4 Perspective 1: Basic concepts of medical device software
      risk management
    5 Perspective 2: Software considerations in medical device
      risk management
    6 Perspective 3: Software risk management within a software
      life cycle
    7 Perspective 4: Soft factors in software risk management
    Annexes
    A - Direct causes sample table
    B - Indirect causes and risk control measures table
        (failures due to unpredictable behaviors)

    Abstract - (Show below) - (Hide below)

    Describes a framework within which experience, insight, and judgment are applied systematically to reduce medical device risks.

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

    Committee SW
    Document Type Standard
    Product Note Reconfirmed 2016
    Publisher Association for the Advancement of Medical Instrumentation
    Status Withdrawn
    Supersedes

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

    ISO/IEC 15026:1998 Information technology System and software integrity levels
    IEEE 610 : 1991 COMPUTER DICTIONARY - A COMPILATION OF IEEE STANDARD COMPUTER GLOSSARIES
    IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    AAMI SW68 : 1ED 2001 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
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