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    I.S. EN 62304:2006&A1:2015

    Current The latest, up-to-date edition.

    Medical device software - Software life-cycle processes (IEC 62304:2006/A1:2015)

    Available format(s):  Hardcopy, PDF

    Language(s):  English - French

    Published date:  03-11-2015

    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)

    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
    Bibliography

    Abstract - (Show below) - (Hide below)

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

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

    Committee TC 62
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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