ГОСТ ISO 10993-12-2015 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 12. Приготовление проб и контрольные образцы

[1]

ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Оценка биологическая медицинских изделий. Часть 1. Оценка и испытания в рамках процесса менеджмента риска)

[2]

ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (Оценка биологическая медицинских изделий. Часть 3. Испытания на генотоксичность, канцерогенность и токсичность, влияющую на репродуктивность)

[3]

ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Биологическая оценка медицинских изделий. Часть 5. Испытания на цитотоксичность in vitro)

[4]

ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Оценка биологическая медицинских изделий. Часть 10. Пробы на раздражение и аллергическую реакцию кожи)

[5]

ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials (Оценка биологическая медицинских изделий. Часть 18. Определение химических характеристик материалов)

[6]

ISO Guide 30 Terms and definitions used in connection with reference materials (Термины и определения, используемые в области контрольных образцов)

[7]

ISO Guide 31 Reference materials - Contents of certificates and labels (Контрольные образцы. Содержание сертификатов и этикеток)

[8]

ISO Guide 33 Uses of certified reference materials (Использование стандартных образцов)

[9]

ISO Guide 34 General requirements for the competence of reference material producers (Общие требования к компетентности изготовителей стандартных образцов)

[10]

ISO Guide 35 Reference materials - General and statistical principles for Certification (Стандартные образцы. Общие и статистические принципы аттестации)

[11]

NF S 90-701, Medico-Surgical Equipment, Biocompatibility of Materials and Medical Devices, Methods for Extraction, 1988

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BRAYBROOK, J.H. and MAC KAY, G.A. Supercritical fluid extraction of polymer additives for use in biocompatibility testing, Polymer International, 27, 1992, pp.157-164

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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 pp.24-27

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United States Pharmacopeia/National Formulary, <88> Biological Reactivity Tests, in vivo

[15]

MHLW Notification (Tsuuchi), Principles for Biological Safety Evaluation of Medical Devices, lyakushin No. 0213001, 2003.02.13

[16]

Memorandum (Jimu-renraku),Guidelines for Specific Biological Tests relevant to the Principles, issued by the MHLW Notification No.0213001, 2003.02.13, Iryokiki-Shinsa No. 36, 2003.03.19

[17]

OECD Environment Directorate, Chemical group and management committee, Third Meeting of OECD Experts on Polymers (Tokyo, 14-16 April 1993), Chairman's Report

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EPA Proposed Rule 40, CFR Part 723 (58FR 7679, February 8, 1993)

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Ash, M. and I. Handbook of Plastic and Rubber Additives, An International Guide to More than 13000 Products by Trade Name, Chemical, Function, and Manufacturer, Gover, USA, 1995 (ISBN 0-566-07594-6)

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Matsuoka, A., Haishima, Y., Hasegawa, C, Matsuda, Y., Tsuchiya, T. Organic solvent extraction of model biomaterials for use in the in vitro chromosome aberration test. J. Biomed. Mater. Res., Part A, 86, 2008, pp.13-22

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Reid, R.C., Sidman, K.R., Schwope, A.D., Till, D.E. Ind. Eng. Chem. Prod. Res. Dev., 19(4), 1980, pp.580-587

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Reid, R.C., Schwope, A.D., Sidman, K.R. Modeling the migration of additives from polymerfilms to foods and food simulating liquids, MIT Industrial Liaison Program Report 1-14-84, Directory of Current Research: 3.04.077

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Tsuji, K., Mizumachi, S., lida, K., Oba, T. Kobunshi Ronbunshu, 34(4), 1977, pp.287-290

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Oba, Т., Tsuji, K., Nakamura, A., Shintani, H., Mizumachi, S., Kikuchi, H., Kaniwa, M.A., Kojima, S., Kanohta, K., Kawasaki, Y., Furuya, Т., Matsumoto, K., Tobe, M. Artificial Organs, 8(4), 1984, pp.429-435

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Shintani, H., Nakamura, A. J. Biomed. Mater. Res., 25, 1991, pp.1275-1286

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Haishima, Y., Hayashi, Y., Yagami, Т., Nakamura, A. J. Biomed. Mater. Res. (Appl. Biomater.), 58, 2001, pp.209-215

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The Japan Society for Analytical Chemistry, Research Committee of Polymer Analysis, Polymer Analysis Handbook, pp.549-558, Kinokuniya-Shoten, Tokyo, 1995 (ISBN 4-314-10110-5 C3043)

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Fuchs O. Solvents and Non-solvents for Polymers in Polymer Handbook (third edition), edited by Brandrup, J. and Immergut, E.H., VII/379-VII/407, Wiley Interscience, 1989

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Vondracek, P. and Dolezel. B. Biostability of Medical Elastomers: A Review, Biomater., 5, 1984, p.209

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Adams, W.P., Robinson, J.В., Rohrich, R.J. Lipid Infiltration as a Possible Biologic Cause of Silicone Gel Breast Implant Aging, Plast. Reconstr. Surg., 101, 1998, p.64

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European Pharmacopoeia 6.0, 3.1 Materials for Containers and Containers, pp. 337-370, 2008

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MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No.20, March 1, 2012. Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices

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Vogel, A. Vogel's Textbook of Practical Organic Chemistry: Experimental Techniques (fifth edition), Chapter 2, Revised by Furniss, B.A. et al., John Wiley & Sons, Inc., New York, 1989

УДК 615.46:002:006.354

МКС 11.100.20

Р20

IDT

Ключевые слова: медицинские изделия, биологическая безопасность, контрольный образец, экстракт, экстракция