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  • 04/30089749 DC : DRAFT DEC 2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES

    Available format(s): 

    Superseded date:  30-11-2006

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    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    Status Superseded
    Superseded By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)

    IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
    ISO/IEC 9126-1:2001 Software engineering Product quality Part 1: Quality model
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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