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  • EN 592 : 2002

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING

    Available format(s): 

    Superseded date:  01-12-2009

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Form and presentation of the instructions for use
    5 Requirements for the content of the instructions for
      use
    6 Requirements for supplementary information
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other provisions
             of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.

    General Product Information - (Show below) - (Hide below)

    Committee TC 140
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    I.S. EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    06/30123163 DC : 0 BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
    UNI EN ISO 18113-5 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING
    UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
    UNI CEI EN 980 : 2009 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    06/30146526 DC : 0 BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
    CSA Z22870 : 2007 : R2013 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CSA Z22870:2007 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CEI UNI EN 1041 : 2014 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    DIN EN 1041:2013-12 Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
    I.S. EN 376:2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    04/30090846 DC : DRAFT JUL 2004 BS ISO 22870 - POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
    00/560160 DC : DRAFT JAN 2000 BS ISO 15197 DETERMINATION OF PERFORMANCE CRITERIA FOR IN VITRO BLOOD GLUCOSE MONITORING SYSTEMS FOR MANAGEMENT OF HUMAN DIABETES MELLITUS
    09/30176675 DC : 0 BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    UNI CEI EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    I.S. EN ISO 18113-1:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS EN ISO 18113-5:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing
    06/30146511 DC : 0 BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
    UNE-EN 1041:2009 Information supplied by the manufacturer of medical devices
    BS EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
    BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    EN 980:2008 Symbols for use in the labelling of medical devices
    I.S. EN 980:2008 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
    06/30122245 DC : 0 EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    I.S. EN ISO 18113-5:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    BS EN 980:2008 Symbols for use in the labelling of medical devices
    EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

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

    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    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/IEC Guide 2:2004 Standardization and related activities General vocabulary
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    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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