Variables affecting simulated use determination of residual ethylene oxide in medical devices

Journal of AOAC International

Volumn 84, Issue 2, 2001, Pages 512-518

  Centola, Duane T ^a,e   Ayoub, Kamal I ^b   Lao, Nelson T ^c   Lu, Hollington T C ^c   Page, Barry F J ^d  

^a Sterilization Technical Services   (United States)

^b Tyco/Healthcare Kendall   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d Barry Page Consulting   (United States)

^e Microban Products Co   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG RESIDUE; ETHYLENE OXIDE;

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; CLINICAL TRIAL; GAS CHROMATOGRAPHY; MULTICENTER STUDY; OCCUPATIONAL EXPOSURE; TEMPERATURE;

CHROMATOGRAPHY, GAS; DRUG RESIDUES; EQUIPMENT AND SUPPLIES; ETHYLENE OXIDE; OCCUPATIONAL EXPOSURE; TEMPERATURE;

EID: 0035288089     PISSN: 10603271     EISSN: None     Source Type: Journal    
DOI: 10.1093/jaoac/84.2.512     Document Type: Article

References (8)

1. Brown, D.J. (1970) J. Assoc. Off. Anal. Chem. 53, 263-267
2. Mogenhan, J.A., Whitbourne, J.E., & Ernest, R.R. (1971) J. Pharm. Sci. 60, 222-224
3. Stetson, J.B., Whitbourne, J.E., & Eastman, C. (1976) Anesthesiology 44, 174-180
4. Hartman, P.A., & Bowman, P.B. (1977) J. Pharm. Sci. 66, 789-792
5. Handlos, V. (1980) Biomaterials 1, 149-157
6. ANSI/AAMI ST29 (1988) Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices, Association for the Advancement of Medical Instrumentation, VA
7. ANSI/AAMI/ISO 10993-7 (1995) Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, Association for the Advancement of Medical Instrumentation, VA
8. AAMI TIR No. 19 (1998) Guidance for ANSI/AAMI/ISO 10993-7: 1995, Biological Evaluation of Medical Derices - Part 7: Ethylene Oxide Sterilization Residuals, Association for the Advancement of Medical Instrumentation, VA