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  • BS IEC 82304-1 : 2016

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-12-2017

    Language(s):  English

    Published date:  01-01-2016

    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

    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)

    Committee CH/62/1
    Development Note Supersedes 15/30246774 DC. (04/2017) Renumbered and superseded by BS EN 82304-1. (01/2018)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Supersedes

    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
    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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