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  • AAMI IEC 62304 : 2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - SOFTWARE LIFE CYCLE PROCESSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-09-2021

    Language(s):  English

    Published date:  01-01-2006

    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
    Introduction to Amendment 1
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Software development PROCESS
    6 Software maintenance PROCESS
    7 Software RISK MANAGEMENT PROCESS
    8 Software configuration management
      PROCESS
    9 Software problem resolution PROCESS
    Annex A (informative) - Rationale for the
            requirements of this standard
    Annex B (informative) - Guidance on the
            provisions of this standard
    Annex C (informative) - Relationship to
            other standards
    Annex D (informative) - Implementation
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Describes the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.

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

    Development Note Supersedes AAMI SW68 (08/2006)
    Document Type Standard
    Product Note NEW CHILD AMD 1 IS ADDED
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    IEEE 730-2014 REDLINE IEEE Standard for Software Quality Assurance Processes
    AAMI TIR45 : 2012 GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE

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

    ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
    IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
    ISO/IEC 25010:2011 Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO/IEC 33001:2015 Information technology Process assessment Concepts and terminology
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
    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
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    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/IEC 33004:2015 Information technology Process assessment Requirements for process reference, process assessment and maturity models
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