ГОСТ IS 010993-7— 2011
Библиография
[1]ISO 11135:1994
[2]EN 550:1994
[3]AAMIEO-VRSU 3181;
Medical devices — Validation and routine control of ethylene oxide sterilization
Sterilization of medical devices — Validation and routine control of ethylene oxide s
terilization
superseded by AAMIGVR-1987. Good hospital practice: Ethylene oxide gas — Ventilation
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[5]ALLEVA. F. (Cited in Balazs. 1976)
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[7]ANDERSEN. S. Ethylene oxide toxicity. J. Lab. C/in. Med. 77(2) 1971; pp. 345—356
[81ANSI/AAM IST29— 1988
[91ANSVAAMIST30 — 1989
[10JASTM E691:1979
Recommended practice for determining residual ethylene oxide in medical devices.
Arlington. VA: AAMI. 1988
Determining residual ethylene chlorohydrin and ethylene glycol n medical devices.
Arlington. VA: AAMI. 1989
Standard practice for conducting an in lerlabora lory comparison study to determine
the precision of test methods. Philadelphia. PA: ASTM. 1979
j
[11JBALAZS. T. Toxicity of ethylene oxide and chtoroethanol. FDA By-lines No. 3. 1976; pp. 150— 155
[12] BALL. N.A. Determination of ethylene chlorohydnn and ethylene glycol in aqueous solutions and ethylene oxide in
associated plastics. J. Pharm. Sci. 73(9) 1984; pp. 1305— 1307
[13]BLOOD. F. Chronic toxicity of ethylene glycol in the rat. Fd. Cosmet. Tox. 3 1965; pp. 229—234
[14} BROBST. K.M. and HAN. T. Determination of chlorohydrins in hydroxypropyl starch ethers. J. Assoc. Off. Anal.
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[15] BROWN. D.J. Determination of ethylene oxide and ethylene chlorohydrin in plastic and rubber surgical equipment
sterilized with ethylene oxide. J. Assoc. Off. Anal. Chem. 53(2) 1970; pp. 263—267
[16] BRUCH. C.W. Industrial Sterilization. Phillips, G.B.. Ш ег, W.S. (Eds.) Durham. NC: Duke University Press, 1973;
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[17] CARPENTER. C.. SMYTH. H. and POZZANI. U. The assay of acute vapor toxicity, and the grading and interpretation
of results on 96 chemical compounds. J. Ind. Hyg. Toxicol. 31 1949; pp. 343— 349 (Cited in EPA. 1985)
[181 CHESLER. S.N.. REBBERT. R.E. and ENAGONIO. D. P. Evaluation of AA Ml EO residues recommended practice
and a determination of EO kinetics in water Washington, DC: National Bureau of Standards. Department of
Commerce. Oct. 1985
[19J CONINE. D.. NAUMANN. B. and HECKER. L. Setting health-based residue limits for contaminants in pharma
ceuticals and medical devices. Ouality Assurance: Good Practice. Regulation, and Law. 1 1992; pp. 171— 180
[20] COURTNEY. K..ANDREWS, J. and GRADY. M. Teratogenic evaluation of ethylene chlorohydrins (Ech, 2-chloroethanol)
in mice. J. Environ. Sci. Health. BI7(4) 1982; pp. 381—391
[21] CYR. W.H.. GLASER. ZR. and JACOBS. M.E. CDRH risk assessment of EO residues on sterilized medical devices In:
Jorkasky. J. (Ed.) Sterilization in the 1990s (Health Industry Manufacturers’ Association Report No. HIMA 89-I).
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[22] DANIELSON. J.W.. SNELL. R.P. and OXBORROW. G.S. Detection and quantitation of ethylene oxide. 2-chloroethanol.
and ethylene glycol with capillary gas chromatography. J. Chromatogr. 28 1990: pp. 97— 101
[23] DEPASS. L.. GARMAN. R.. WOODSIDE. M„ GIDDENS. W.. MARONPOT. R. and WEIL. C. Chronic toxicity and
carcinogenicity studies of ethylene glycol in rats and mice. Fund. Appl. Tox. 7 1986: pp. 547—565
[24] DUNKELBERG. H. Carcinogenicity of ethylene oxide and 1.2-propylene oxide upon intragastric administration to
rats. Br. J. Cancer. 46 1982; pp. 924—933
[25] EDELHAUSER. H.. ANTOINE. M.. PEDERSON. H.. HIDDEMAN. J. and HARRIS. R. Intraocular safety evaluation of
ethylene oxide and steriant residues. J. Toxicol. Cut. and Ocular Toxicol. 2 1983; pp. 7—39
[26] Environ. Ethylene Oxide Residues on Sterilized Medical Devices. Washington. DC. Environ Corporation. 1987.
(Also in: Health Industry Manufacturers Association. H ’MA Report 88-6. Washington. DC: HIMA. 1988)
[27] ETTRE, L.S. and JONES. E. Quantitative analysis with headspace gas chromatography using multiple headspace
extraction. Chromatography Newsletter. 12( 1) July 1984
[28] GAUNT. J.. HARDY. J.. GANGOLLI. S.. BUTTERWORTH. K. and LLOYD. A. B/BRA. 14 1975: p. 109. (Cited in Rowe
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[29]GLASER. Z.R. Ethylene oxide: Toxicology review and field study results of hospital use. 4. Environ. Path. Tox. 2
1979; pp. 173—208
[30]GOLBERG. L. Hazard Assessment of Ethylene Oxide. Boca Raton. FL: CRC Press. 1986
[31]GUESS. W. Tissue reactions to 2-chloroethanol in rabbits. Tox. Appl. Pharm. 16 1970; pp. 382—390
[32]Guidelines for data acquisition and data quality evaluation in environmental chemistry. Anal. Chem. 52(14) 1980.
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