ГОСТ Р ИСО 10993-12—2009
Библиография
[1] ИСО Руководство 30 Термины и определения, используемые в области контрольных образцов
ISO Guide 30 Terms and definitions used in connection with reference materials
[2] ИСО Руководство 31 Контрольные образцы. Содержание сертификатов и этикеток
ISO Guide 31 Reference materials — Contents of certificates and labets
[3] ИСО Руководство 33 Использование стандартных образцов
ISO Guide 33 Uses ofcertified reference materials
[4] ИСО Руководство 34 Общие требования к компетентности изготовителей стандартных образцов
ISO Guide 34 General requirements for the competence of reference material producers
[5] ИСО Руководство 35 Стандартные образцы. Общие и статистические принципы аттестации
ISO Guide 35 Reference materials — General and statistical principles for certification
[6] BRAYBROOK. J.H. and MACKAY. G.A. Supercritical fluid extraction of polymer additives for use in blocompatlbllity
testing. Polymer International. 27.1992. pp. 157—164
[7]NF S 90—701 Medico-Surgical Equipment. Blocompatlbllity of Materials and Medical Devices. Methods for
Extraction. 1988
[8] 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/National Formulary. <88> Biological Reactivity Tests. In Vivo
[10] MHLW Notification (Tsuuchi). Principles for Biological Safety Evaluation ofMedical Devices, lyakushin No.0213001.
2003.02.13
[11] Memorandum (Jimu-renraku).Guidelines forSpecific Biological Tests relevanttothe Principles, issued by the MHLW
Notification No.0213001.2003.02.13. Iryoklki-Shmsa No.36. 2003.03.19
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