An MD&DI February 1997 Feature
STERILIZATION
Speeding EtO-Sterilized Products to Market with Parametric Release (continued)
References
1. Medical Devices--Validation and Routine Control of Ethylene Oxide Sterilization, ANSI/AAMI/ISO 11135, Arlington, VA, Association for the Advancement of Medical Instrumentation (AAMI), 1994.
2. Medical Devices--Validation and Routine Control of Ethylene Oxide Sterilization, ANSI/AAMI/ISO 11135, Section 7.2, Parametric Release, Arlington, VA, AAMI, 1994.
3. Sterilization of Medical Devices--Validation and Routine Control of Ethylene Oxide Sterilization, EN 550:1994, Section B.5.2, Parametric Release, Brussels, European Committee for Standardization, 1994.
4. Sordellini PJ, "Parametric Release Comes to EtO Sterilization," Med Dev Diag Indust, 18(2):66-69, 1996.
5. AAMI Technical Information Report on Engineering Aspects of Industrial EtO Sterilization, 4th working draft, Arlington, VA, AAMI, June 1996.
6. AAMI Technical Information Report on Contract Sterilization for Ethylene Oxide, 3rd working draft, Arlington, VA, AAMI, March 1996.
7. Hoborn J, "Ethylene Oxide Sterilisation--A Proven Method," in Ethylene Oxide Sterilisation Conference Proceedings, London, EUCOMED, pp 33-50, 1989.
8. Code of Federal Regulations, 40 CFR 9 and 63, "National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations."
9. Manning CR, "Validating EtO Packaging/Sterilizer Configurations," Med Dev Diag Indust, 11(1):130-136, 1989.
10. Harris DC, Quantitative Chemical Analysis, New York, W. H. Freeman, pp 551-605, 1982.
11. Segal BG, Chemistry, Experiment and Theory, 2nd ed, New York, John Wiley, 1989.
12. Smith BC, Fundamentals of Fourier Transform Infrared Spectroscopy, Boca Raton, FL, CRC Press, 1996.
13. Efiok BJS, Basic Calculations for Chemical and Biological Analyses, Gaithersburg, MD, AOAC International, 1995.
14. Zhu Z, Gibson C, Samuel AH, et al., "A Microwave Spectrometer with a Frequency Control System Employing a Frequency Scanning Window Locked to the Rotational Absorption Peak," Rev Sci Instrumentation, 66(10), 1995.
15. Zhu Z, Gibson C, Samuel AH, et al., "A Gas Monitoring System for Ethylene Oxide Sterilizers with Constant Sample Flow through a Microwave Cavity Spectrometer," J Med Eng Tech, 17(4):147-151, 1993.
16. Samuel AH, and Matthews IP, Sterilizing Procedures and Equipment, U.S. Patent No. 5,209,902, 1993.
17. Samuel AH, and Matthews IP, Sterilizing and Desorbing Equipment, U.S. Patent No. 5,399,314, 1995.
18. Zhu Z, Gibson C, Samuel AH, et al., "Microwave Cavity Spectrometer for Process Monitoring of Ethylene Oxide Sterilization," Rev Sci Instrumentation, 64(1), 1993.
19. Matthews IP, Gibson C, and Samuel AH, "Enhancement of the Kinetics of the Aeration of Ethylene Oxide Sterilized Polymers Using Microwave Radiation," J Biomed Mat Res, 23:143-156, 1989.
20. Shugar GJ, Shugar RA, Bauman L, et al., Chemical Technician's Ready Reference Handbook, New York, McGraw-Hill, 1981.
21. Announcement from the Ethylene Oxide Sterilization Association, Washington, DC, June 5, 1996.
