ГОСТ Р ИСО 22870—2009
Библиография
[1] Руководство ИСО/МЭК 43-1Оценка качества исследований путем межлабораторных сравнений.
Часть 1. Разработка и деятельность схем внешней оценки качества
[2] EN 376:2002
Information supplied by the manufacturers with In vitro diagnostics for self-testing
[3] EN 593:2002
Instructions for use for in vitro diagnostic instruments for self-testing
[4] Jansen R.T.P.. Blaton V.. Burnett D.. Hulsman W.. Oueralto J.M.. Zerah S.. Allman B. European Communities
Confederation of ClinicalChemistry. Essentialcriteria for quality systems of medical laboratories. European Journal of
Clinical Chemistry and Clinical Biochemistry. 35, 1997, pp. 123— 132
[5] Jansen R.T.P . Blaton V.. Burnett D., Hulsman W.. Oueralto J.M., Zerah S.. Allman B. European Communities
Confederation of ClinicalChemistry. Additional essential criteria for quality systems of medical laboratories. Cluneal
Chemistry and Laboratory Medicine, 36. 1998. pp. 249—252
[6J Jacobs E. In: Kaplan and Pesce. eds. РОСТ in Clinical Chemistry Theory. Analysis and Correlation. 4” ed. St.Louis.
Mosby and Co; 2003
[7) Price C.P.. St. John and Hicks J.M. Pomt-of-Care Testing. 2M ed. Washington ОС. AACC Press. 2004
[8) MDA DB 2002(03). Management and Use of IVD Point of Care Test Devices. Medical Devices Agency; UK, 2002
[9) MDA DB 2002(02). Management of in vitro Diagnostic Medical Devices. Medical Devices Agency. UK. 2002
(10J Burnett D. Accreditation and point-of-care testing. Ann. Clin. Blochem. 37. 2000, pp. 241—243
(11) Freedman D.B. Clinical governance: Implications for pomt-of-care testing. Ann. Clm. Biochem. 39. 2002.
pp. 421—423
(12) РОСТ Guidelines v.1.0. JpnJ.Clin.Lab. Automation. 29. suppl. 3, 2004
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