ГОСТ РИСО 15193—2015
(13J ISO 18153. In vitro diagnostic medical devices — Measurement ol quantities in biological samples — Metrolo
gical traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
(14]ISO/IEC Guide 15. ISO/1EC code of principles on «reference to standards»
(15]ISO Guide 32. Calibration in analytical chemistry and use of certified reference materials
(16]ISO Guide 33. Uses of certified reference materials
(17]ISO Guide 34. General requirements for the competence of reference matenal producers
(18]ISOi’lEC Directives, Part 1. 2008. Procedures for the technical work
(19]ISO/IEC Directives. Part 2. 2004. Rules for the structure and drafting of International Standards
(20]DIN 1333. Presentation of numerical data
(21]IFCC Guidelines (1984) for listing specifications of clinical chemical analysers, in Saris N-E <ed.) IFCC
(International Federation of Clinical Chemistry) Recommendations and related documents 1978— 1983. vol. 1
(1984). pp. 109—113
122] IUPAC Nomenclature for sampling In analytical chemistry. Recommendations 1990. Pure Appl. Chem.62 (1990).
pp. 1193— 1208
(23] NCCLS/CLSI Evaluation of precision performance of quantitative measurement methods. Approved guideline,
second edition. NCCLS/CLSI Document EP5-A2. 24(25}(2004) viil ♦ 39
(24] NCCLS/CLSI Protocols for determination of limits of detection and limits of quantitation. Proposed guideline,
NCCLS/CLSI Document EP17-A 24 (34X2004) viil ♦ 38
(25] Dybkaer, R. Vocabulary for Use m Measurement Procedures and Description of Reference Materials in
Laboratory Medicine. Eur. J. Clin. Chem. Clin. Biochem. 35 (2) (1997). pp. 141 — 173
(26] Commission Directive of 14 July 1976 adapting to technical progress the Council Directive of 27 June 1967
concerning the approximation of the laws, regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances. OJEC. 1976, No L 360. pp. 1—424
127] Commission Directive of July 1983 adapting to technical progress for the fifth time Council Directive 67/548/EEC on
the approximation of the laws, regulations and administrative provisions relating to the classification,
packaging and labeBIng of dangerous substances. OJEC. 1983, No L 257. pp. 1—33
УДК 61:003:054:006.354OKC 11.100.10
Ключевые слова: медицинские изделия для диагностики in vitro, пробы биологического происхождения,
референтная методика выполнения измерения, требования к описанию
Редактор Л И. Нахимова
Технический редактор В Н. Прусакова
Корректор В.И. Варемцова
Компьютерная верстка И.А Напсикимой
Сдано в набор 25.05.2015.Подписано о печать 01.06.2015.Формат 60 к 84у£.Гарнитура Ариал.
Уел. печ. л. 2,32. Уч.-изд. п. 1.90Тираж 30 зкэЗак. 2047.
Издано и отпечатано во ФГУП «СТАНДАРТИНФОРМ», 123995 Москва. Гранатный пер.. 4.
www.gosUnto.ru
mfo@0ostin(o.ru
ГОСТ Р ИСО 15193-
2015