ГОСТ ISO 10993-18—2011
[8] EN 455-3:1999 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation
(9] EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 1:
Analysis and management of risk
(10J EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 2:
Controls on sourcing, collection and handling
(11) EN 12442-3:2000 Animal tissues and their derivatives utilized In the manufacture of medical devices — Part 3:
Validation of the elimination and/or inactivation of viruses and transmissible agents
(12J International Union of Pure and Applied Chemistry — Macromolecular division — Commission on macromolecutar
nomenclature: compendium of macromolecular nomenclature. Prepared for publication by W. V. Metanomski,
Blackwell Scientific Publications Ltd.. Oxford. 1991
(13) OECD Guidelines 120:1996. Solutionfextraction behaviour of polymers in water
(14) JP XIV General tests/plastlc containers. 2001
(15) OECD Guidelines 118:1996, Determination of the number-averaged molecular weight and molecular weight
distribution of polymers using gel permeation chromatography
(16) USP26. 2003. <661 > Containers
(17) Ph. Eur. Ed. 4. 2002. Section 2.2.28 and Chapters 3.1 and 3.2
УДК 615.46:002:006.354МКС 11.100.20P20IDT
Ключевые слова: медицинские изделия, идентификация материала, химические составляющие, биоло
гическая безопасность
Рода crop
Н В. Таланова
Технический редактор
Е.В. Беслрозванная
Корректор JV.fl.
Бучная
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ГОСТ ISO 10993
-18-2011