ГОСТ ISO 10993-12—2011
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Библиография
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ISO Guide 30 Terms and definitions used m connection with reference materials
(Термины и опредепемия. используемые в области контрольных образцов)
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ISO Guide 31 Reference materials — Contents of certificates and labels
(Контрольные образцы. Содержание сертификатов и этикеток)
(3)
ISO Guide 33 Uses of certified reference materials (Использование стандартных образцов)
ИI
ISO Guide 34 General requirements for the competence of reference material producers
(Общие требования к компетентности изготовителей стандартных образцов)
IS]
ISO Guide 35 Reference materials — General and statistical principles for certification
(Стандартные образцы. Общие и статистические принципы аттестации)
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6
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BRAYBROOK. J.H. and MACKAY. G.A. Supercntical fluid extraction of polymer additives for use in biocompatibility
testing. Polymer International, 27.1992. pp. 157—164
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NF S 90-701 Medico-Surgical Equipment. Biocompatibility of Matenats and Medical Devices. Methods for Extraction.
1988
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8
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UPHILL. P.F. and CHRISTOPHER. D.H. Developing a Positive Control for Cytotoxicity Testing of Medical Device
Materials. Medical Device Technology. Nov/Dec 1990. pp. 24—27
|9]
United States Pharmacopeia/Natlonal Formulary. <88> Biological Reactivity Tests. In Vivo
110
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MHLW Notification (Tsuuchi). Principles for Biological Safety Evaluation of Medical Devices, lyakushm No.0213001,
2003.02.13
111
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Memorandum (Jlmu-renraku).Guidellnes for Specific Biological Tests relevant to the Principles, issued by the MHLW
Notification No.0213001.2003.02.13, Iryokikl-Shmsa No.36. 2003.03.19
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