ГОСТ ISO 10993-17-2011 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 17. Установление пороговых значений для вымываемых веществ (с Поправкой)

[1]

ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

(Оценка биологического действия медицинских изделий. Часть 7. Остаточное содержание этиленоксида после стерилизации)

[2]

ISO 14971

Medical devices - Application of risk management to medical devices

(Устройства медицинские. Применение управления рисками к медицинским устройствам)

[3]

LEHMAN, A.J. and FITZHUGH, O.G. (1954). 100-Fold margin of safety. Association of Food and Drug Officials. U.S.Q. Bull. 18, pp.33-35

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MUMTAZ, M.M. and HERTZBERG, R.C. (1993). The status of interactions data in risk assessment of chemical mixtures. In J. Saxena, ed. Hazard Assessment of Chemicals, Vol. 8, pp.47-79. Hemisphere, Washington, D.C.

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MUMTAZ, M.M., SIPES, I.G., CLEWELL, H.J. and YANG, R.S.H. (1993). Risk assessment of chemical mixtures: Biologic and toxicologic issues (symposium overview). Fund. Appl. Toxicol. 21, pp.258-269

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Pharmaceutical Manufacturers Association (PMA) (1989). Procedures for setting limits for volatile organic solvents with methylene chloride as an example of the process. Committee on Rational Specification for Impurities in Bulk Drug Substances. PMA, Washington, DC. Pharmacopeial Forum 15(6), pp.5748-5759

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Pharmaceutical Manufacturers Association (PMA) (1990). Procedures for setting limits for volatile organic solvents with chloroform, 1,4-dioxane, ethylene oxide and trichloroethylene as examples of the process. Committee on Rational Specification for Impurities in Bulk Drug Substances. PMA, Washington, DC. Pharmacopeial Forum 16(3), pp.541-582

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Pharmaceutical Manufacturers Association (PMA) (1991). Procedures for setting limits for volatile organic solvents with benzene as an example of the process. Committee on Rational Specification for Impurities in Bulk Drug Substances. PMA, Washington, DC. Pharmacopeial Forum 17(1), pp.1441-1458

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United States Pharmacopeial Convention (USP) (2000) Vol. 24, pp.1877-1878. <467> Organic volatile impurities. USP, Rockville, Maryland

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BASKETTER, D.A. (1996). Individual ethnic and seasonal variability in irritant susceptibility of skin: The implications for a predictive human patch test. Contact Dermatitis 35, pp.208-213

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CONINE, D., NAUMANN, B. and HECKER, L. (1992). Setting Health-Based Residue Limits For Contaminants in Pharmaceuticals and Medical Devices. Quality Assurance: Good Practice, Regulation, and the Law. 1(3), pp.171-180

[12]

Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment, Guidelines for the evaluation of chemicals for carcinogenicity, Department of Health Report on Health and Social Subjects No. 42, HMSO, London, 1991

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DOURSON, M. and STARA, J. (1983). Regulatory history and experimental support for uncertainty (safety) factors. Reg. Toxicol. Pharmacol. 3 pp.224-238

[14]

CRUMP, K. (1984). A new method for determining allowable daily intakes. Fund. Appl. Toxicol. 4, pp.854-871

[15]

JUDGE, M.R. (1996). Variation in response of human skin to irritant challenge. Contact Dermatitis 34, pp.115-117

[16]

LEWIS, S., LYNCH, J. and NIKIFOROV, A. (1990). A new approach to deriving community exposure guidelines from no-observed-adverse-effect level. Reg. Toxicol. Pharmacol. 11, pp.314-330

[17]

KADRY, A., SKOWRONSKI, G. and ABEL-RAHMAN, M. (1995). Evaluation of the Use of Uncertainty Factors in Deriving RfDs for Some Chlorinated Compounds. J. Toxicol. Environ. Health 45, pp.83-95

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SEED, J., BROWN, R.P. OLIN, R.P. and FORAN, J.A. (1995). Chemical mixtures: Current risk assessment methodologies and future directions. Reg. Toxicol. Pharmacol. 22, pp.76-94

[19]

World Health Organization (WHO) (1994). Environmental Health Criteria 170. Asessing Human Health Risks of Chemicals: Derivation of Guidance Values for Health-Based Exposure Limits. World Health Organization. Geneva, Switzerland

УДК 615.46:002:006.354

МКС 11.100.20

Р20

Ключевые слова: медицинские изделия, допустимые предельные значения, методы определения, пороговые значения, допустимые уровни, фактор, уровень