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  • UNE-EN ISO 18113-3:2012

    Current The latest, up-to-date edition.

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

    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 591. (01/2013)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    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
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
    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
    EN 980:2008 Symbols for use in the labelling of medical devices
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