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    I.S. EN 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  16-07-2020

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    National Foreword
    European foreword
    FOREWORD
    INTRODUCTION
    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
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EC Directives
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE.

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

    Committee ISO/IEC JTC 1
    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

    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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