ГОСТ Р 70413—2022
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Библиография
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IEC 60050-300:2001
International Electrotechnical Vocabulary — Electrical and electronic measurements and
measuring instruments — Part 311: General terms relating to measurements — Part 312:
General terms relating to electrical measurements — Part 313: Types ofelectrical measuring
instruments — Part 314: Specific terms according to the type of instrument
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ISO/IEC 80000-1:2009
[3]
ISO 15189:2012
[4]
ISO 17511:2003*
[5]
ISO/TS 21748:2010**
Quantities and units — Part 1: General
Medical laboratories — Requirements for quality and competence
In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values assigned to calibrators and control materials
Guidance forthe use ofrepeatability, reproducibility and trueness estimates in measurement
uncertainty estimation
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IFCC-IUPAC coding system for nomenclature, properties and units (C-NPU). International Federation of Clinical
Chemistry and Laboratory Medicine (IFCC) in collaboration with International Union of Pure and Applied Chemistry
(IUPAC).
http://www.npu-terminology.org/npu-database/(last
update April 2018)
[7]
International Union of Pure and Applied Chemistry (IUPAC) Compendium of Chemical Terminology, (Gold Book)
Version 2.3.3 2014-02-24
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JCGM 100:2008, Evaluation of measurement data — Guide to the expression of uncertainty in measurement
[9]
JCGM 200:2012International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
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CLSI C24, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. Approved
Guideline, Wayne, PA, Fourth Edition, 2016
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11 CLSI EP05, Evaluation of Precision Performance of Quantitative Measurement Methods. Approved Guideline, CLSI,
Wayne, PA, Third Edition, 2014
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CLSI EP09c. Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Approved Guide
line, CLSI, Wayne, PA, Third Edition, 2018
[13] CLSI EP15. User Verification of Performance for Precision and Trueness; Approved Guideline, CLSI, Wayne, PA,
Third Edition, 2014
[14] CLSI EP26-A. User Evaluation of Between-Reagent Lot Variation, Approved Guideline. CLSI: Wayne, PA, Approved
Guideline, 2013
[15] CLSI EP29-A. Expression of Measurement Uncertainty in Laboratory Medicine, CLSI, Wayne, PAApproved Guide
line, 2012
[16] EURACHEM/CITAC Guide CG 4, Quantifying uncertainty in analytical measurement, Third Edition, 2012.
www.eu-
rachem.org
(accessed 15/10/13)
[17] Eurolab Technical Report N0.1/2006 Guide to the evaluation of measurement uncertainty for quantitative test results.
August 2006.
www.eurolab.org/documents
(Accessed 16-09-16)
[18] National Pathology Accreditation Advisory Council (NPAAC) Requirements for the Estimation of Measurement Un
certainty, 2007 Edition),
www.health.gov.au
[19] Infusino I., Panteghini M. Measurement uncertainty: Friend or foe? // Clin Biochem, Feb 2 2018
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Braga F., Pasqualetti S., Panteghini M. The role of external quality assessment in the verification of in vitro medical
diagnostics in the traceability era // Clin Biochem, Feb 9 2018
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Miller W. G., Jones G. R., Horowitz G. L., Weykamp C. Proficiency testing/external quality assessment: current chal
lenges and future directions // Clin Chem, vol. 57, no. 12, pp. 1670—80, Dec 2011
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Sandberg S. et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Con
ference of the European Federation of Clinical Chemistry and Laboratory Medicine // Clin Chem Lab Med, vol. 53, no.
6, pp. 833—5, May 2015
* Заменен на ISO 17511:2020 «Изделия медицинские для диагностики in vitro. Требования к установлению
метрологической прослеживаемости значений, приписанных калибраторам, контрольным материалам пра
вильности и образцам биологического материала человека».
**Заменен на ISO 21748:2017 «Статистические методы. Руководство по использованию оценок повторя
емости, воспроизводимости и правильности при оценке неопределенности измерений».
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