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  • UNE-EN ISO 18113-5:2012

    Current The latest, up-to-date edition.

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  22-02-2012

    Publisher:  Asociacion Espanola de Normalizacion

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    Committee CTN 129
    Development Note Supersedes UNE EN 592. (01/2013)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
    ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    EN 980:2008 Symbols for use in the labelling of medical devices
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