• UNE-EN 1041:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Information supplied by the manufacturer of medical devices

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-03-2014

    Language(s):  Spanish, Castilian, English

    Published date:  18-02-2009

    Publisher:  Asociacion Espanola de Normalizacion

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    Committee CTN 111
    Development Note 2009 Edition Re-Issued in March 2014 & incorporates AMD 1 2014. (03/2014)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    Supersedes

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

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    ISO 639-1:2002 Codes for the representation of names of languages — Part 1: Alpha-2 code
    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
    2004/108/EC : 2004 DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 DECEMBER 2004 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ELECTROMAGNETIC COMPATIBILITY AND REPEALING DIRECTIVE 89/336/EC
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
    EN ISO 3166-1:2014 Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2013)
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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