ГОСТ Р ИСО 15197-2015 Тест-системы для диагностики in vitro. Требования к системам мониторинга глюкозы в крови для самоконтроля при лечении сахарного диабета

[1]

ISO/IEC Guide 99:2007, International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

[2]

ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions

[3]

ISO 5725-1, 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

[4]

ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method

[5]

US Food and Drug Administration, Draft Guidance for Industry, Clinical Investigators and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigators for Medical Devices, Issued on August 15, 2011. Available at http://www.fda.gov/ Medical Devices/DeviceRegulationand Guidance/GuidanceDocuments/um265553.htm. Accessed on 2011-11-26

[6]

Mosby's Medical Dictionary. Elsevier, Eighth Edition, 2009

[7]

Evaluation of Precision Performance of Qualitative Measurement Methods; Approved Guidance-Second Edition; CLSI document EP5-A2, Wayne, PA: Clinical and Laboratory Standards Institute; 2004

[8]

CHAN A.Y., SWAMINATHAN R., COCKRAN C.S. Effectiveness of sodium fluoride as a preservative of glucose in blood. Clin Chem/1989, 35 (2) pp.315-317

[9]

JCTLM database: Laboratory medicine and in vitro diagnostics, Database of higher-order referace materials, measurement methods/procedures and services (Bureau international des poids et measures (BIPM), Sevre (FRANCE). Available at http://www.bipm.org/jctlm/. Accessed on 2011-02-09

[10]

PARKES et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care, 2000, 23 (8) pp.1143-1148

[11]

Method comparison and bias estimation using patient samples; Approved Guidance-Second Edition; CLSI document EP9-A2, Wayne, PA: Clinical and Laboratory Standards Institute; 2002

[12]

BLAND J.M., ALTMAN D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet, 1986, 1, pp.307-310

[13]

Interference Testing in Clinical Chemistry: Approved Guidance-Second Edition; CLSI document EP7-A2, Wayne, PA: Clinical and Laboratory Standards Institute; 2005

[14]

Self-monitoring of blood glucose. American Diabetes Association. Diabetes Care. 1994, 17 (1) pp.81-86

[15]

American Diabetes Association. Consensus statement on self-monitoring of blood glucose. Diabetes Care. 1987, 10 (1) pp.95-99

[16]

BOYD J.C., BRUNS D.E. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem. 2001, 47 pp.209-214

[17]

BOYD J.C., BRUNS D.E. Monte Carlo Simulation in Establishing Analytical Quality Requirements for Clinical Laboratory Tests: Meeting Clinical Needs, Methods in Enzymology Chapter 16, Elsevier Inc, Vol.467, 2009

[18]

The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group (DCCT). N.Engl.J.Med. 1993, 329 (14) pp.977-986

[19]

Council Directive 98/79/EC of the European Parlament and of the Council m0f 27 October 1998 on in vitro Diagnostic Medical Devices, Official Journal of the European Union L331, December 7, 1998

[20]

Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine = First Edition. CLSI document C53-A, Wayne, PA: Clinical and Laboratory Standards Institute; 2010

УДК 64:003:054:006.354

ОКС 11.100.10

Ключевые слова: сахарный диабет, системы для диагностики in vitro, мониторинг глюкозы в крови, самоконтроль, оценка безопасности применения и надежности систем, требования к точности систем мониторинга, оценка системы пользователем