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  • EN 82304-1:2017

    Current The latest, up-to-date edition.

    Health Software - Part 1: General requirements for product safety

    Available format(s): 

    Language(s): 

    Published date:  01-09-2017

    Publisher:  European Committee for Standards - Electrical

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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
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications

    Abstract - (Show below) - (Hide below)

    IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

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

    Committee CLC/TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Current

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

    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    UNE-EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006)

    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
    NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
    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
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    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
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/IEC 12207:2008 Systems and software engineering 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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