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    I.S. EN 82304-1:2017

    Current The latest, up-to-date edition.

    HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    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
    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)

    Pertains 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.

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

    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (09/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

    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
    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
    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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