Problems associated with sterilization using ethylene oxide. Residues in treated materials

Central European Journal of Public Health

Volumn 7, Issue 4, 1999, Pages 197-202

  Buben, I ^a   Melichercikova V ^b   Novotna N ^a   Svitakova R ^c  

^a State Institute for Drug Control   (Czech Republic)

^b NATIONAL INSTITUTE OF PUBLIC HEALTH   (Czech Republic)

^c INSTITUTE OF MACROMOLECULAR CHEMISTRY   (Czech Republic)

Author keywords

Ethylene oxide residues; Medical devices; Sterilization with ethylene oxide

Indexed keywords

ETHYLENE OXIDE; POLYMER;

AERATION; ARTICLE; DEVICE; EQUIPMENT; INSTRUMENT STERILIZATION;

ACRYLATES; DISINFECTANTS; EQUIPMENT AND SUPPLIES; ETHYLENE OXIDE; HUMANS; MATERIALS TESTING; POLYMERS; STERILIZATION;

EID: 0033397251     PISSN: 12107778     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Melicheříková, V.: Sterilization and disinfection. Grada Publishing 1998.
2. CSN EN 550, Sterilization of medical devices - validation and routine control of ethylene oxide sterilization.
3. Romano, S. J., Renner, J. A., Leitner, P. M.: Gas chromatography determination of residual ethylene oxide by head space analysis Anal. Chem. 45, 1973, 2327-2330.
4. CL 97, 3.2.6 Sets for transfusion of blood and blood constituents 3 2 8. Sterile single-use syringes. Grada Prague 1997.
5. Ph. Eur. 3. ed. 1997. VI.2.2.2.4 Sets for transfusion of blood and blood components. VI.2.2.4. Sterile single-use plastic syringes.
6. CSN ENISO 10993-7 Biological evaluation of medical devices - part 7: Ethylene oxide sterilization residuals.
7. Empfehlungen zur Verwendung von Ethylenxoid, Bundesgesund-heitsblatt 1986, p. 21.
8. Ethylene oxide, ethylene chlorohydrin and ethylene glycol. proposed maximum residue limits and maximum levels of Exposure. Federal register FDA, 43, 1978, 122-Friday.
9. Buben, I., Melicherčíková, V., Novotná, V., Svitáková, R.: Some problems associated with sterilization with ethylene oxide from the aspect of persistence in treated materials. Second Conference on "Hospital Hygiene", Ústi nad Labem 21.-22.10.1997.
10. th International Conference "Chromatographic Methods and Human Health", Piešẗany 10.-13.11.1997.
11. Buben, I., Novotná, N., Melicherčíková, V., Svitáková, R.: Use of ethylene oxide sterilization. Seminar "Topics of Central Sterilization", Trojanovice 28.9-30 9.1998.
12. Buben, I., Novotná, N., Svitáková, R., Melicherčíková, V.: Monitoring ethylene oxide in medical equipment. Chemické hsty, in press.
13. Schnädelbach, D., Ansmann, A., Bertram, J., Buben, I., Johnson, R., Miller, J. H. McB, Reilly, A., Schoenfelder, W., Stegmaier, W., Wozniak, J.: Determination of ethylene oxide and other toxic residues derived from the synthesis of pharmaceutical substances and excipients. Pharmeuropa 8, 1996, 593-603.