ГОСТ ISO 17511-2011
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In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of valuesassigned to calibrators and control materials.
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Statistics; vocabulary and symbols; part 1: probability and general statistical terms ( In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials ( In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurement procedures ( Guide to the expression of uncertainty in measurement, 1 st edit., ISO, Geneve, 1993 ( Quality management systems — Fundamentalsand vocabulary ( Accuracy (trueness and precision) of measurement methods and results. Part 1. General principles and definitions ( 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 ( Accuracy (trueness and precision) of measurement methods and results. Part 3. Intermediate measures of the precision of a standard measurement method ( Accuracy (trueness and precision) of measurement methods and results. Part 6. Use in practice of accuracy values ( Kobold U, Jeppsson JO, DulferT, Finke A, Hoelzel W, Miedema K. Candidate reference methods for HbA1 c based on peptide mapping. Clin. Chern. 1997; 43: 1944—51 Clin. Lab.Haemat. 1994; 16: 131—138
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