ГОСТ Р ИСО 10993-7— 2009
[63)LYNCH. D.. LEWIS. Т.. MOORMAN. W.. BURG. J.. GROTH. D.. KHAN. A.. ACKERMAN. L. and COCKERELL. B.
Carcinogenic and toxicologic effects of inhaled ethylene oxide and propylene oxide in F344 rats. Tox. Appl.
Pharm. 76 1984; pp. 69 — 84
[64) MALANOSKI. A.J. Analyst performance standards; Determination for and from collaborative studies. J. Assoc. Off.
Anal. Chem. 65<6) 1982; pp. 1333 — 1338
[65) MANIUS, G.J. Determination of ethylene oxide, ethylene chlorohydrin. and ethylene glycol residues in ophthalmic
solution at proposed concentration limits. J. Pharm. Sci. 68(12) 1979; pp. 1547 — 1549
[66) MARLOWE. D.E.. LAO. N T.. LAO. C.S.. EATON. A.R. and PAGE. B.F.J. Interlaboratory Comparison of Ethylene
Oxide Residue Analysis Test Methods (HHS Publication FDA 86-4204). Mar. 1986
[67) MARLOWE. D.E. Summary of results from interiaboratory comparison of ethylene oxide residue analysis test
methods. Paper presented at AAMI Conference on In-hospital EO Sterilization, Arlington. Virginia. Nov. 1983
[68)MARLOWE. D.E.. LAO. N.T.. EATON. A.R.. PAGE. B.F.J. and LAO. C.S. Ап I nterlaboratory comparison of analytical
methods for ethylene oxide. J. Pharm. Sci. 76 1986; pp. 333 — 337
[69) MASON. M.. CATE. C. and BAKER. J. Toxicology and carcinogenesis of various chemicals used in the preparation
of vaccines. СЛп. Toxicol. 4(2) 1971; pp. 185 — 204
[70) MATSUMOTO. T.. HARDAWAY. R.M.. PANI. K.C.. SATER. C.M.. BARTAK. D.E. and MARGETIS. P.M. Safestandard
of aeration for ethylene oxide sterilized supplies. Arch. Surg. 96 1968; pp. 464 — 470
[71) MCDONALD. T.. ROBERTS. M. and BORGMANN. A. Ocular toxicity of ethylene chlorohydrin and ethylene glycol in
rabbit eyes. Tox. Appl. Pharm. 21 1972; pp. 143 — 150
[72) MCDONALD. T.. KASTEN. K.. HERVEY. R.. GREGG. S.. BORGMANN. A. and MURCHESON. T. Acute ocular
toxicity of ethylene oxide, ethylene glycol and ethylene chlorohydrin. Bull. Parent. Drug Assoc. 27(4) 1973; pp. 153
— 164
[73) MCDONALD. T.. KASTEN. K.. HERVEY. R.. GREGG. S. and BUTTON. B. Acute ocular toxicity for normal and
irritated rabbit eyes and subacute ocular toxicity for ethylene oxide, ethylene chlorohydrin and ethylene glycol. Bull.
Parent. Drug Assoc. 31( 1) 1977; pp. 25 — 32
[74) MOGENHAN, J.A.. WHITBOURNE. J.E. and ERNST. R.R. Determination of ethylene oxide in surgical materials by
vacuum extraction and gas chromatography. J. Pharm. Sci. 60(2) 1971; pp. 222 — 224
[75) MORRIS. T.. NELSON. M. and CALVERY. A. Observations on the chronic toxicities of propylene glyco ethylene
glycol, diethytene glycol, ethylene glycol mono-ethyl-ether, and diethylene glycol mono-methyl-ether. J. Pharm.
Exp. Ther. 74 1942; pp. 266 — 273
[76) MUZENI. R.J. Rapid gas chromatographic determination of ethylene oxide, ethylene chlorohydrin. and ethylene
glycol residues in rubber catheters. J. Assoc. Off. Anal. Chem. 68(3) 1985; pp. 506 — 508
[77) NAKAMURA. A.. KIKUCHI. H. and TSUJI. K. Determination of ethylene oxide residue in commercially available
intraocular lenses by new sensitive method (Electron capture detection/gas chromatography). IOL. 3 1989; pp. 4
— 8
[78) NORTHUP. S.. WEINCKOWSKI. D„ MARTIS. L. and DARBY. T. Toxicitycaused by acute and subacute intravenous
administration of ethylene oxide in the rat. J. Environ. Pathol. Toxicol. 5 1981; pp. 617 — 623
[79) National Toxicology Program. Toxicology and Carcinogenicity Studies of 2-Chloroethanol (Ethylene Chlorohydrin)
(CAS. No. 107-07-03) in F344/N Rats and Swiss CD-1 Mice (Dermal Studies) (NTP TR275. NIH Publication 86-
2531). Research Triangle Park. NC; NTP. 1985
[80) National Toxicology Program. Toxicology and Carcinogenicity Studies of Ethylene Oxide (CAS No. 75-2 1-8) in
B6C3F 1 Mice (Inhalation Studies) (NTP Technical Report 326. U.S. Department of Health and Human Services.
Public Health Services. National Institute of Health). Research Triangle Park. NC; NTP. 1987
[81)OBA. T„ TSUJI. K.. MIZUMACHI. S.. KIKUCHI. H.. SHINTANI. H„ IIDA. K. and MEGURO. K. Studies on residual
ethylene oxide in medical devices (I) — Gas chromatographic determination of ethylene oxide in plastics. Ikakikai-
gaku. 52(3) 1982; pp. 134 — 139
[82)OHBA. T. Safety of residual ethylene oxide and ethylene oxide concentrations in the working environment of
sterilization facilities. In: Gaughren. E., Morrissey. R.: You-sen. W.. (Eds.). Sterilization of Medical Products
Volume IV. Montreal. Canada; Pofyscience Publications. Inc.. 1986; pp. 172 — 177
[83)OSER. B.. MORGAREIDGE. K.. Cox. G. and CARSON. J. Short-term toxicity of ethylene chlorohydrin (ECH) in rats,
dogs and monkeys. Fd. Cosmet. Tox. 13 1975: pp. 313 — 315
[84)PATEL. A. (unpublished data presented to ISOnC 194/WG11 by A. Patel, Alcon Laboratories. Inc. and his colleagues
at the WG meeting in Minneapolis. MN. Sept. 1993)
[85) Pharmaceutical Manufacturers’ Association. Procedures for setting limits for volatile organic solvents with
methylene chlonde as an example of the process. Committee on Rational Specifications for Impurities in Bulk
Drug Substances — Parmaceutical Manufacturers’ Association. In: Pharmacopeia! Forum. Washington. DC;
PMA Nov. — Dec. 1989; pp. 5748 — 5759
[86) Pharmaceutical Manufacturers’ Association. Application of the PMA procedure for setting residue limits for organic
volatile solvents in pharmaceuticals to ethylene oxide. Prepared by D.L. Conine and the PMA subcommittee of
Industrial Toxicologists. Procedures for setting limits for organic volatile solvents with chloroform. 1,4-dioxane.
ethylene oxide, and trichloroethylene as examples of the process. Committee on Rational Specifications for
Impurities in Bulk Drug Substances — Parmaceutical Manufacturers’ Association. In; Pharmacopeial Forum.
Washington. DC; PMA. May-June 1990; pp. 557 — 572
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