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  • CLSI C51 P : 1ED 2010

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE

    Available format(s): 

    Superseded date:  31-01-2012

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
    3 Terminology
    4 Strategies to Estimate Measurement Uncertainty
    5 Overview of Measurement Uncertainty
    6 Bottom-up Uncertainty Estimation
    7 Top-Down Approach to Estimation of Measurement Uncertainty
    8 Bias Assessment
    9 Uses of Uncertainty Estimates
    10 Summary
    References
    Additional References
    Appendix A - Transformation of Type B Limit Specifications
    Appendix B - Uncertainty Estimates from Routine Quality
                 Control Results
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Defines a practical approach to developing relevant and useful estimates of measurement uncertainty and for using the information to maintain and improve the quality and application of clinical laboratory measurements.

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

    Document Type Proposed Guideline
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By

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

    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)
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS

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

    CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
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