Extraction and stability of ethylene oxide residue in medical devices

Biomedical Instrumentation and Technology

Volumn 42, Issue 1, 2008, Pages 76-79

  Lucas, Anne D ^a   Stratmeyer, Melvin E ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

CELL CULTURE; EXTRACTION; MEDICAL APPLICATIONS; SAMPLING; SOLUTIONS;

ETHYLENE OXIDE (EO) GAS; MEDICAL DEVICES;

BIOMEDICAL EQUIPMENT;

ETHYLENE OXIDE;

ANALYTIC METHOD; ARTICLE; INSTRUMENT STERILIZATION; MEDICAL INSTRUMENTATION; STANDARDIZATION; TECHNIQUE; TECHNOLOGY; WATER TREATMENT;

EQUIPMENT AND SUPPLIES; ETHYLENE OXIDE; STERILIZATION; UNITED STATES;

EID: 39149095612     PISSN: 08998205     EISSN: None     Source Type: Journal    
DOI: 10.2345/0899-8205(2008)42[76:EASOEO]2.0.CO;2     Document Type: Article

References (13)

1. MacNeil JR, Glaser ZR. Comparison of health care-based sterilization technologies: Safety, efficacy, and economics. J Healthc Safety Compliance Infect Control. 1997;Dec:91-106.
2. Matthews IP, Gibson C, Samuel AH. Sterilisation of implantable devices. Clin Materials. 1994;15:191-215.
3. Brinston RM. The economics of sterilization. Med Device Technol. 1995;6:16-22.
4. International Agency for Research on Cancer. Ethylene Oxide. IARC monograph on evaluation of carcinogenic risk of chemicals to humans. 1985;36:189-226.
5. Thier R, Bolt HM. Carcinogenicity and genotoxicity of ethylene oxide: new aspects and recent advances. Crit Rev Tox. 2000;30:595-608.
6. Dellarco VL, Generoso WM, Sega GA, Fowle JR, Jacobson-Kram D. Review of the mutagenicity of ethylene oxide. Environ Mol Mutagen. 1990;16:85-103.
7. World Health Organization. Ethylene Oxide. Environmental Health Criteria 55, World Health Organization: Geneva, Switzerland; 1985.
8. International Organization for Standardization. Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. ANSI/AAMI/ISO 10993-7. Arlington, VA: Association for the Advancement of Medical Instrumentation; 1995.
9. Association for the Advancement of Medical Instrumentation. Technical Information Report (TIR 19) Guidance for ANSI/AAMI/ISO 10993-7: 1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. Arlington, VA: Association for the Advancement of Medical Instrumentation, AAMI TIR 19; 1998.
10. Lucas AD, Merritt K, Hitchins V, Woods T, McNamee S, Lyle DB, Brown SA. Residual ethylene oxide in medical devices and device material. J Biomed Mat Res Appl Biomat. 2003;66B:548-552.
11. ASTM F 619-03. Standard Practice for Evaluation of Medical Plastics. In The Annual Book of ASTM Standards. West Conshohocken, PA: ASTM; 2003.
12. International Organization for Standardization. Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials. ANSI/AAMI/ISO 10993-12. Arlington, VA: Association for the Advancement of Medical Instrumentation; 1999.
13. Centola DT, Ayoub KI, Lao NT, Lu TC, Page BFJ. Variables affecting simulated use determination of residual ethylene oxide in medical devices. JAOC. 2001;84:512-518.