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Kolupaev V.E.

Bio-Rad Laboratories, Moscow, Russia

The implementation of «measurement uncertainty» concept to clinical diagnostics lab practice according to the requirements of GOST ISO 15189 – 2015

Authors:

Kolupaev V.E.

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Journal: Laboratory Service. 2019;8(1): 86‑92

Read: 2330 times


To cite this article:

Kolupaev VE. The implementation of «measurement uncertainty» concept to clinical diagnostics lab practice according to the requirements of GOST ISO 15189 – 2015. Laboratory Service. 2019;8(1):86‑92. (In Russ.)
https://doi.org/10.17116/labs2019801186

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References:

  1. GOST R ISO 15189-2015. Medical laboratories. Particular requirements for quality and competence. Accessed: Oct, 28 2018] docs.cntd.ru/document/1200119946
  2. Bureau International des Poids et Mesures. JCGM 200:2012 International Vocabulary of Metrology—Basic and General Concepts and Associated Terms, 2008 Version with Minor Corrections. 3rd ed. Sèvres: BIPM; 2012. Retrieved from: http://www.BIPM.org/utils/common/documents/jcgm/JCGM_200_2012.pdf. Accessed: Oct, 28 2018.
  3. Pereira P. Uncertainty of Measurement in Medical Laboratories, New Trends and Developments in Metrology Luigi Cocco, IntechOpen, https://doi.org/10.5772/62437. Available from July 20th 2016: https://www.intechopen.com/books/new-trends-and-developments-in-metrology/uncertainty-of-measurement-in-medical-laboratories
  4. ISO/IEC 31010: 2009 Risk management — Risk assessment techniques. Accessed: Oct, 28 2018] https://ivan-shamaev.ru/wp-content/uploads/2013/05/31010-2011_Russia.pdf
  5. ISO/IEC Guide 98-3:2008. Uncertainty of measurement. Part 3. Guide to the expression of uncertainty in measurement. Accessed: Oct, 28 2018] http://docs.cntd.ru/document/1200146871
  6. Dybkaer R. Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine. Scandinavian Journal of Clinical And Laboratory Investigation. 1999;59(7):579-583. https://doi.org/10.1080/00365519950185391
  7. Fraser CG. Biological variation remains relevant. Pathology. 2015; 47:S17. https://doi.org/10.1097/01.pat.0000461381.28757.e3
  8. Guide technique d’accreditation pour l’evaluation des incretitudes de mesure en biologie medicale. SH GTA 14.Révision 00. 2007. — 26 p. Retrieved from: https://www.cofrac.fr/documentation/SH-GTA-14 Accessed: Oct, 29 2018

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