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  • 15/30246774 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2017

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 HEALTH SOFTWARE PRODUCT requirements
    5 HEALTH SOFTWARE - Software life cycle processes
    6 HEALTH SOFTWARE PRODUCT VALIDATION
    7 HEALTH SOFTWARE PRODUCT identification and
      ACCOMPANYING DOCUMENTS
    8 Post-market activities for the HEALTH SOFTWARE PRODUCT
    Annex A (informative) - Rationale
    Bibliography
    Index

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

    Comment Closes On
    Committee CH/62/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    IEC 61907:2009 Communication network dependability engineering
    ISO/TR 17791:2013 Health informatics Guidance on standards for enabling safety in health software
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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