ГОСТ ISO 10993-17-2011
Библиография
(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
[4] 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.
[5J 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
[6] 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
[7) 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
[8] 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
[9) United States Pharmacopeial Convention (USP) (2000) Vol. 24, pp. 1877 - 1878.
<467> Organic volatile impurities. USP, Rockville, Maryland
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