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09/30205176 DC : 0

Current

Current

The latest, up-to-date edition.

ISO/TS 25680 - MEDICAL LABORATORIES - CALCULATION AND EXPRESSION OF MEASUREMENT UNCERTAINTY

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English

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Utility of measurement uncertainty
   4.1 General
   4.2 Utility related to a target measurement
        uncertainty
   4.3 Utility for laboratory
   4.4 Utility for clinician
   4.5 Role of metrological traceability
5 Fundamental concepts of measurement
   5.1 Measurement
   5.2 Measurement error and measurement uncertainty
   5.3 Defining a measurand
6 Practical process of calculating measurement uncertainty
   6.1 Sources of measurement uncertainty
   6.2 Considerations in defining a measurand
   6.3 Target measurement uncertainty
   6.4 Recalculation of measurement uncertainty
7 Summary procedure for calculating and expressing measurement
   uncertainty
8 Reporting measurement uncertainty
   8.1 Records
   8.2 Terminology
   8.3 Summary reporting of best estimate of measurand, y,
        with combined standard measurement uncertainty,
        u[c](y)
   8.4 Summary reporting of best estimate of measurand,
        y, with expanded measurement uncertainty, U = ku[c](y)
   8.5 Significant digits and rounding
   8.6 Supplementary information
   8.7 Availability of data for measurement uncertainty
Annex A (normative) - Calculation of measurement uncertainty
        from a measurement model
   A.1 Measurement model, measurement function
   A.2 Evaluating probability distribution, best estimate,
        and standard measurement uncertainty
        A.2.1 Replicate measurements
        A.2.2 Specified limits
        A.2.3 Results from certificates
        A.2.4 Measurement results from previous measurements
   A.3 Calculating combined standard measurement uncertainty,
        covariance, and correlation coefficient
        A.3.1 Calculating combined standard measurement
              uncertainty
        A.3.2 Calculating covariance and correlation coefficient
   A.4 Calculating expanded measurement uncertainty, coverage
        probability, coverage factor, and coverage interval
Annex B (normative) - Simple measurement models - Measuring
        system, sampling, and intraindividual variation
   B.1 Measuring system
        B.1.1 Measurement model, measurement function
        B.1.2 Best estimates and standard measurement uncertainties
              of input quantities
        B.1.3 Best estimate and measurement uncertainty of output
              quantity
   B.2 Sampling
        B.2.1 Measurement model, measurement function
        B.2.2 Best estimates and standard measurement uncertainties
              of input quantities
        B.2.3 Best estimate and measurement uncertainty of
              output quantity
   B.3 Intraindividual variation
        B.3.1 Measurement model, measurement function
        B.3.2 Best estimates and standard measurement uncertainties
              of input quantities
        B.3.3 Best estimate and measurement uncertainty of output
              quantity
Annex C (informative) - Examples - Measurement uncertainty of
        measured quantity values
   C.1 Amount-of-substance concentration of glucose in plasma
        Plasma-Glucose; substance concentration NPU02192 Bottom-up
        approach
        C.1.1 Definition of measurand
        C.1.2 Measurement procedure
        C.1.3 Measurement function
        C.1.4 Evaluation of input quantities
        C.1.5 Sensitivity coefficients
        C.1.6 Combined standard measurement uncertainty
        C.1.7 Uncertainty budget
        C.1.8 Report of measurement result
   C.2 International Normalized Ratio (INR) for coagulation
        in plasma P-Coagulation, tissue factor-induced;
        relative time(actual/norm; INR; IRP 67/40; procedure)
        NPU01685
        C.2.1 Definition of measurand
        C.2.2 Measurement procedure
        C.2.3 Measurement function
        C.2.4 Evaluation of input quantities
        C.2.5 Sensitivity coefficients
        C.2.6 Combined standard measurement uncertainty
        C.2.7 Uncertainty budget
        C.2.8 Report of measurement result
Annex D (informative) - Measurement trueness and measurement
         precision
   D.1 Measurement precision
   D.2 Measurement trueness
Bibliography

ISO/TS 25680

Committee
CH/212
DocumentType
Draft
Pages
60
PublisherName
British Standards Institution
Status
Current

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
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/TS 14253-2:1999 Geometrical Product Specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 2: Guide to the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification
ISO/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
ISO 15193:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO/TS 21749:2005 Measurement uncertainty for metrological applications — Repeated measurements and nested experiments
ISO/TR 22971:2005 Accuracy (trueness and precision) of measurement methods and results Practical guidance for the use of ISO 5725-2:1994 in designing, implementing and statistically analysing interlaboratory repeatability and reproducibility results
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/TS 14253-3:2002 Geometrical Product Specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 3: Guidelines for achieving agreements on measurement uncertainty statements
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 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO 3534-2:2006 Statistics — Vocabulary and symbols — Part 2: Applied statistics
ISO/TS 21748:2004 Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation
ISO/TR 13425:2006 Guidelines for the selection of statistical methods in standardization and specification
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
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 3534-3:2013 Statistics — Vocabulary and symbols — Part 3: Design of experiments
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 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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