ГОСТ ISO 10993-7-2011 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 7. Остаточное содержание этиленоксида после стерилизации

[1]

ISO 11135:1994

Medical devices - Validation and routine control of ethylene oxide sterilization

[2]

EN 550:1994

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

[3]

AAMI EO-VRSU 3181;

superseded by AAMI GVR-1987, Good hospital practice: Ethylene oxide gas - Ventilation recommendations and safe use. Arlington, VA: AAMI, 1981

[4]

ADLER, N. Residual ethylene oxide and ethylene glycol in ethylene oxide sterilized pharmaceuticals. J. Pharm. Sci. 54(5) 1965; pp.735-742

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ALLEVA, F. (Cited in Balazs, 1976)

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ANDERSEN, S. Ethylene oxide toxicity. J. Lab. C/in. Med. 77(2) 1971; pp.346-356

[8]

ANSI/AAM I ST29-1988

Recommended practice for determining residual ethylene oxide in medical devices. Arlington, VA: AAMI, 1988

[9]

ANSl/AAM I ST30-1989

Determining residual ethylene chlorohydrin and ethylene glycol in medical devices. Arlington, VA: AAMI, 1989

[10]

ASTM E691:1979

Standard practice for conducting an in terlabora tory comparison study to determine the precision of test methods. Philadelphia, PA: ASTM, 1979

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BALAZS, T. Toxicity of ethylene oxide and chloroethanol. FDA By-lines No. 3. 1976; pp.150-155

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BALL, N.A. Determination of ethylene chlorohydrin and ethylene glycol in aqueous solutions and ethylene oxide in associated plastics. J. Pharm. Sci. 73(9) 1984; pp.1305-1307

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BLOOD, F. Chronic toxicity of ethylene glycol in the rat. Fd. Cosmet. Tox. 3 1965; pp.229-234

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COURTNEY, K., ANDREWS, J. and GRADY, M . Teratogenic evaluation of ethylene chlorohydrins (Ech, 2-chloroethanol) in mice. J. Environ. Sci. Health. Bl7(4) 1982; pp.381-391

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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

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DUNKELBERG, H. Carcinogenicity of ethylene oxide and 1,2-propylene oxide upon intragastric administration to rats. Br. J. Cancer. 46 1982; pp.924-933

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EDELHAUSER, H., ANTOINE, M., PEDERSON, H., HIDDEMAN, J. and HARRIS, R. Intraocular safety evaluation of ethylene oxide and sterilant residues. J. Toxicol. Cut. and Ocular Toxicol. 2 1983; pp.7-39

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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)

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ETTRE, L.S. and JONES, E. Quantitative analysis with headspace gas chromatography using multiple headspace extraction. Chromatography Newsletter. 12(1) July 1984

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GAUNT, J., HARDY, J., GANGOLLI, S., BUTTERWORTH, K. and LLOYD, A. B/BRA. 14 1975; p.109. (Cited in Rowe and Wolf, 1982 and Environ, 1987)

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GLASER, Z.R. Ethylene oxide: Toxicology review and field study results of hospital use. 4. Environ. Path. Tox. 2 1979; pp.173-208

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GOLBERG, L. Hazard Assessment of Ethylene Oxide. Boca Raton, FL: CRC Press, 1986

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Guidelines for data acquisition and data quality evaluation in environmental chemistry. Anal. Chem. 52(14) 1980

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HACKETT, P., BROWN, R., BUSCHBOOM, R., CLARK, M., MILLER, R., MUSIC, R., ROWE, S., SCHIRMER, R. and SIKOV, M. Teratogenic Study of Ethylene Oxide and Propylene Oxide and n-Butyl Acetate (NIOSH Contract No. 21 O-80-001 3). Richland, WA: Battelle Pacific Northwest Laboratories, 1982. (Cited in EPA, 1985.)

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HANDLOS, V. Determination of gas residuals in ethylene oxide sterilized materials - A literature survey. Archiv. Pharm. Chemi. Sci. 4 1976; pp.73-80

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HANDLOS, V. The hazards of ethylene oxide sterilization. Arch. Pharm. Chemi. Sci. 7 1979; pp.939-949

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HARTMAN, P.A. and BOWMAN, P.B. Simple GLC determination of ethylene oxide and its reaction products in drug and formulations. J. Pharm. Sci. 66(6) 1977; pp.789-792

[37]

Health Industry Manufacturers' Association. Guidelines for the Analysis of Ethylene Oxide Residues in Medical Devices (HIMA Document No. 1, Vol. 2). Washington, DC: HIMA, 1980

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HOLLINGSWORTH, R., ROWE, V., OYEN, F., MCCALLISTER, D. and SPENCER, H. Toxicity of ethylene oxide determined on experimental animals. AMA Arch. Ind. Health. 13 1956; pp.217-227

[39]

HUBAUX, A. and GILBERT, V. Decision and detection limits for linear calibration curves. Anal. Chem. 42(8) 1970; pp.849-855

[40]

Improved detection and separation of glycols and ethylene oxide residues using GC. (Bulletin 789), Supelco, Inc.; 1980

[41]

JACOBSON, K., HACKLEY, E. and FEINSILVER, L. The toxicity of inhaled ethylene oxide and propylene oxide vapors. AMA Arch. Ind. Health. 13 1956; pp.237-244

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JOHNSON, M. Metabolism of chloroethanol in the rat. Biochem. Pharmacol. 16 1967a; pp.185-199

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JONES-PRICE, C., KIMMEL, T., MARKES, T., LEDOUX, T., REEL, J., FISCHER, P., LANGHOFF-PASCHKE, L. and MARR, M. Teratologic Evaluation of Ethylene Oxide (CAS No. 75-78-8) in New Zealand White Rabbits (Final report RB80-EO, NIEHS Contract No. I-ES-2127). Research Triangle Park, NC: National Institute of Environmental Health Sciences, 1982. (Cited in EPA, 1985)

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JONES-PRICE, C., MARKS, T., LEDOUX, T., REEL, J., FISCHER, P., LANGHOFF-PASCHKE, L., MARR, M. and KIMMEL, C. Teratologic Evaluation of Ethylene Chlorohydrin (CAS No 107-07-3) in New Zealand White Rabbits (PB85-170959). Research Triangle Park, NC: National Institute of Environmental Health Sciences, 1985a

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JONES-PRICE, C., MARKS, T., LEDOUX, T., REEL, J., FISCHER, P., LANGHOFF-PASCHKE, L., MARR, M. and KIMMEL, C. Teratologic Evaluation of Ethylene Chlorohydrin (CAS No 107-07-3) in CD-1 mice (PB85-172104). Research Triangle Park, NC: National Institute of Environmental Health Sciences, 1985b

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KAREL, L., LANDING, B. and HARVEY, T. The intraperitoneal toxicity of some glycols, glycol ethers, glycol esters and phthalates in mice. Fed. Proceedings. 6 1947; p.342

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KASHTOCK, M. Use of specific retention volumes in evaluation of various types of columns for use in the trace determination of ethylene glycol by gas chromatography. J. Chromatogr. 176 1979; pp.25-35

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KAYE, M.M. and NEVELL, T.G. Statistical evaluation of methods using headspace gas chromatography for the determination of ethylene oxide. Analyst. 110 1985; pp.1067-1071

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KIKUCHI, H., NAKAMURA, A. and TSUJI, K. Gas chromatographic determination with electron capture detection of residual ethylene oxide in intraocular lenses. J. Assoc. Off. Anal. Chem. 71 1988; pp.1057-1062

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KROES, R., BOCK, B. and MARTIS, L. Ethylene oxide extraction and stability in water and blood. Personal communication to the AAMI Committee, Jan 1985

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KULKARNI, R.K., BARTAK, D., OUSTERHOUT, D.K. and LEONARD, F. Determination of residual ethylene oxide in catheters by gas-liquid chromatography. J. Biomed. Mat. Res. 2 1968; pp.165-171

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LABORDE, J. and KIMMEL, C. The teratogenicity of ethylene oxide administered intravenously to mice. Tox. Appl. Pharm. 56 1980; pp.16-22

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LANDEN, W.O., THOMPSON, D.W. and FLOYD, K.M. Determination of ethylene oxide and ethylene glycol in wet surgical dressings. FDA By-Lines, No 2, 1971

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LATVEN, A. and MOLITOR, H. Comparison of the toxic, hypnotic and irritating properties of eight organic solvents. J. Pharm. Exp. Ther. 65 1939; pp.89-94

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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

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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

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MARLOWE, D.E. Summary of results from interlaboratory comparison of ethylene oxide residue analysis test methods. Paper presented at AAMI Conference on In-hospital EO Sterilization, Arlington, Virginia, Nov. 1983

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_______________

* Текст документа соответствует оригиналу. - Примечание изготовителя базы данных.

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