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  • EN 13532:2002

    Current The latest, up-to-date edition.

    General requirements for in vitro diagnostic medical devices for self-testing

    Available format(s): 

    Language(s): 

    Published date:  17-04-2002

    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 Design criteria
    5 Markings and information supplied by the manufacturer
    6 Performance evaluation
    7 User verification
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.

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

    Committee CEN/TC 140
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    I.S. EN ISO 22870:2016 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016)
    BS EN ISO 22870:2016 Point-of-care testing (POCT). Requirements for quality and competence
    EN ISO 22870:2016 Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
    11/30208525 DC : 0 BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    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 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence
    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
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    PREN ISO 15197 : DRAFT 2011 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS

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

    EN 1658 : 1996 REQUIREMENTS FOR MARKING OF IN VITRO DIAGNOSTIC INSTRUMENTS
    EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
    EN 61326:1997/A3:2003
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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