ГОСТ Р ИСО 10993.7-99 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 7. Остаточное содержание этиленоксида после стерилизации

ПРИЛОЖЕНИЕ Ж
(справочное)

     
Библиография

[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[3] AAMI EO-VRSU 3/81; superseded by AAMI GVR - 1987, Good hospital practice: Ethylene oxide gas - Ventilation recommendations and safe use.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 ethelene glycol in ethylene oxide sterilized pharmaceuticals. J. Pharm. Sci. 54(50) 1965; pp.735-742

[5] Alleva F. (Cited in Balazs, 1976)

[6] Ambrose, A. Toxicological studies of compounds investigated for use as inhibitors of biological processes. II Toxicity of ethylene chlorohydrin. Arch. Ind. Hyg. Occup. Med. 2 1950; pp.582-597

[7] Andersen, S. Ethylene oxide toxicity. J. Lab. Clin. Med. 77(2) 1971; pp.346-356

[8] ANSI/AAMI ST29 - 1988, Recommended practice for determining residual ethylene oxide in medical devices. Arlington, VA: AAMI, 1988

[9] ANSI/AAMI 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 interlaboratory comparison study to determine the precision of test methods. Philadelphia, PA: ASTM, 1979

[11] Balazs, Т. Toxicity of ethylene oxide and chloroethanol. FDA BY-lines No. 3 1976; pp.150-155

[12] 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

[13] Blood, F. Chronic toxicity of ethylene glycol in rat. Fd. Cosmet. Tox. 3 1965; pp.229-234

[14] Brobst, K.M and Han, Т. Determination of chlorohydrins in hydroxypropyl starch ethers. J. Assoc. Off. Anal. Chem. 54(5) 1971; pp.1093-1094

[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(20) 1970; pp.263-267

[16] Bruch, C.W. Industrial Sterilization. Phillips, G.B, Miller, W.S. (Eds.) Durham, NC: Duke University Press 1973; pp.49-77

[17] Carpenter, С., 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, 19850)

[18] Chesler, S.N., Rebbert, R.E. and Enagonio, D.P. Evaluation of AAMI EO residues recomended practice and a determination of EO kinetics in water. Washington, DC; National Bureau of Standards, Department of Commerce, Oct. 1985

[19] Conine, D., Naumann, B. and Hecker, L. Setting health-based residue limits for contaminants in pharmaceuticals and medical devices. Quality Assurance: Good Practice, Regulation, and Law. 1 1992; pp.171-180

[20] Courtney, R., Andrews, J. and Grady, M. Teratogenic evaluation of ethylene chlorohydrin (Ech, 2-chloroethanol) in mice. J. Environ. Sci. Health. B17 (40) 1982; pp.381-391

[21] Cyr, W.H., Glaser, Z.R. 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 89-1). Washington, DC: HIMA, 1989; pp.269-285

[22] Danielson J.W., Snell, R.P. and Oxborrow, G.S. Detection and quantification 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 Wiel, C. Chronic toxicity and carcinogenicity tudies 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 sterilant 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, HIMA 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