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ISO/TS 25680 - MEDICAL LABORATORIES - CALCULATION AND EXPRESSION OF MEASUREMENT UNCERTAINTY
Hardcopy , PDF
English
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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