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  • DIN EN 62304 : 2016

    Current The latest, up-to-date edition.

    MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES

    Available format(s):  Hardcopy

    Language(s):  German

    Published date:  01-10-2016

    Publisher:  Verband Deutscher Elektrotechniker

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    Development Note Supersedes DIN IEC 62304. (04/2005)
    Document Type Standard
    Publisher Verband Deutscher Elektrotechniker
    Status Current

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

    DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    VDI 5702 Blatt 1:2017-04 Medical device software - Medical SPICE Process assessment model
    VDI/VDE 2657 Blatt 1:2013-01 Middleware in industrial automation - Fundamentals
    DIN EN ISO 80601-2-72 E : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
    DIN EN ISO 11608-1:2015-04 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
    DIN EN ISO 20072:2013-10 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
    DIN EN ISO 11608-1 E : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
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