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  • AAMI TIR32 :2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICE SOFTWARE RISK MANAGEMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-11-2017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 2004
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    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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