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  • UNE-EN ISO 15197:2015

    Current The latest, up-to-date edition.

    In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  23-09-2015

    Publisher:  Asociacion Espanola de Normalizacion

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Design and development
      4.1 General requirements
      4.2 Safety
      4.3 Traceability
      4.4 Ergonomic/human factor aspects
      4.5 Risk analysis
      4.6 User verification
    5 Information supplied by the manufacturer
      5.1 Labels for the blood-glucose meter
      5.2 Instructions for use for the blood-glucose monitoring
           system
      5.3 Labels for the reagent system and control material
      5.4 Instructions for use for reagents and control material
    6 Safety and reliability testing
      6.1 General requirements
      6.2 Protection against electric shock
      6.3 Protection against mechanical hazards
      6.4 Electromagnetic compatibility
      6.5 Resistance to heat
      6.6 Resistance to moisture and liquids
      6.7 Protection against liberated gases, explosion and
           implosion
      6.8 Meter components
      6.9 Performance test
      6.10 Mechanical resistance to shock, vibration and impact
      6.11 Equipment temperature exposure limits
      6.12 Equipment humidity exposure test protocol
      6.13 Reagent storage and use testing
    7 Analytical performance evaluation
      7.1 General requirements
      7.2 Precision evaluation
      7.3 System accuracy evaluation
      7.4 Minimum acceptable system accuracy
    8 User performance evaluation
      8.1 General
      8.2 Evaluation sites
      8.3 User evaluation
      8.4 Evaluation for instructions for use
    Annex A (normative) Additional requirements for electromagnetic
            compatibility
    Annex B (informative) Traceability chain
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users.

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

    Committee CTN 129
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    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
    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)
    EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC 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 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 60068-2-64:2008 ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
    ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
    ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
    ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
    ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    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
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    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)
    EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
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