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  • EN 12286:1998/A1:2000

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES

    Available format(s): 

    Withdrawn date:  24-11-2000

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Presentation of a reference measurement procedures
    Annex A (informative) Reference procedures for
            properties other than quantities
    Annex B (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for the drafting of a reference measurement procedure. Applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

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

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    Status Withdrawn

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

    BS EN ISO 18153:2003 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
    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 12287 : 1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS
    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)
    I.S. 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
    DIN EN ISO 18153:2003-11 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES FOR CATALYTIC CONCENTRATION OF ENZYMES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
    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
    BS EN 12287:1999 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials
    EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
    01/561148 DC : DRAFT MAR 2001 BS EN 14136 - USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC PROCEDURES
    DIN EN ISO 17511:2003-11 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
    BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
    BS 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
    EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
    EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
    00/565675 DC : DRAFT DEC 2000 BS EN ISO 17511 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
    BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
    DIN EN 14136:2004-08 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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

    ISO 6353-3:1987 Reagents for chemical analysis — Part 3: Specifications — Second series
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
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