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  • UNI EN ISO 15193 : 2009

    Current The latest, up-to-date edition.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES

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    Published date:  02-09-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    PREMESSA
    INTRODUZIONE
    1 SCOPO E CAMPO DI APPLICAZIONE
    2 RIFERIMENTI NORMATIVI
    3 TERMINI E DEFINIZIONI
    4 PRESENTAZIONE DI UNA PROCEDURA DI MISURA DI RIFERIMENTO
    APPENDICE A (informativa) - PROCEDURE DI RIFERIMENTO PER LE
      PROPRIETA DIVERSE DALLE GRANDEZZE DIFFERENZIALI E
      RAZIONALI
    APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
      EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE 98/79
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Describes requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

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

    Committee CT 44
    Development Note Supersedes UNI EN 12286. (10/2009)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    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
    ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
    ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
    ISO 4791-1:1985 Laboratory apparatus — Vocabulary relating to apparatus made essentially from glass, porcelain or vitreous silica — Part 1: Names for items of apparatus
    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
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
    ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
    ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
    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 6353-3:1987 Reagents for chemical analysis — Part 3: Specifications — Second series
    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
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO Guide 34:2009 General requirements for the competence of reference material producers
    ISO 78-2:1999 Chemistry Layouts for standards Part 2: Methods of chemical analysis
    ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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