Commutability evaluation of reference materials of composition and properties of substances and materials
https://doi.org/10.20915/2077-1177-2016-0-3-61-68
Abstract
The International Organization for Standardization laid down modern requirements for reference material producers (ISO 17034:2016), testing and calibration laboratories (ISO 15025:2005), stipulating the evaluation of reference material commutability in the course of their development (ISO Guide 35:2006) and use (ISO Guide 33:2006). The article deals with general issues of reference material commutability evaluation, the cases when the commutability evaluation is useful and the description of the approach, which may be used in the processing measurement results when evaluating the commutability of reference materials.
References
1. ГОСТ ISO Guide 34-2014 Общие требования к компетентности изготовителей стандартных образцов. М. : Стандартинформ, 2015. 40 с.
2. ISO 17034:2016 General requirements for the competence of reference material producers // ISO [сайт]. URL: www. iso. org/iso/ home/store/catalogue_tc/catalogue_detail. htm?csnumber=29357.
3. РМГ 29-2013 ГСИ. Метрология. Основные термины и определения. М. : Стандартинформ, 2014. 60 с.
4. ГОСТ ISO 17511-2011 Изделия медицинские для диагностики in vitro. Измерение величин в биологических пробах. Метро логическая прослеживаемость значений, приписанных калибраторам и контрольным материалам. М. : Стандартинформ, 2007 31 с
5. Information on commutability of reference materials // ISO Committee on Reference Materials, July, 2014.
6. ГОСТ ISO Guide 35-2015 Стандартные образцы - Общие и статистические принципы сертификации (аттестации). М. : Стандартинформ, 2016. 61 с.
7. ГОСТ Р ИСО 15194-2013 Изделия медицинские для диагностики in vitro. Измерение величин в пробах биологического происхождения. Требования к аттестованным стандартным образцам и содержанию сопроводительной документации. М. : Стандартинформ, 2014. 22 с.
8. CLSI/NCCLS C53-P, Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Proposed Guideline, January 2008.
9. CLSI Guide ER14-A2 (2005), Evaluation of Matrix Effects: Approved Guideline.
10. CLSI Report X5-R (2006), Metrological Traceability and Its Implementation; A Report.
11. Vesper H.W., Miller W.G., Myers G.L. Reference materials and commutability // Clin. Biochem. Rev. 2007. Vol. 28. P. 14. URL: www. ncbi. nlm. nih. gov/pmc/articles/PMC2282402.
12. CLSI Guideline C53-A Characterization and qualification of commutable reference materials for laboratory medicine.
13. ISO Guide 31:2015 Reference materials - Contents of certificates, labels and accompanying documentation // ISO [сайт]. URL: www. iso. org/iso/ru/home/store/catalogue_tc/catalogue_detail. htm?csnumber=52468.
14. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories // ISO [сайт]. URL: www iso org/iso/ru/home/store/catalogue_tc/catalogue_detail htm?csnumber=39883
15. ISO Guide 33:2000 Uses of certified reference materials // ISO [сайт] URL: www iso org/iso/ru/home/store/catalogue_tc/ catalogue_detail. htm?csnumber=46212.
Review
For citations:
Osintseva E.V. Commutability evaluation of reference materials of composition and properties of substances and materials. Measurement Standards. Reference Materials. 2016;(3):61-68. (In Russ.) https://doi.org/10.20915/2077-1177-2016-0-3-61-68
Views:
9494
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0).
Email this article 
