Medical Sterilization
Applicable Standards, Guidelines, and References

Regulatory Standards and Guidelines

AAMI/ANSI/ISO11137:1994, Sterilization of health care products - Requirements for validation and routine control – Radiation Sterilization.

AAMI/ANSI/ISO11737-1:1995, Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products.

ANSI/AAMI /ISO 11737-2:1998, Sterilization of medical devices - Microbiological methods - Part 2:Tests of sterility performed in the validation of a sterilization process.

AAMI TIR No. 17 - 1997, Radiation Sterilization - Material qualification.

ISO 9002:1994, Quality systems - Model for quality assurance in production, installation and servicing.

BS EN 46001:1994, Application of EN29001 (BS 5750:Part 1) to the manufacture of medical devices.

BS EN 552:1994, Sterilization of medical devices - Validation and routine control of sterilization by irradiation.

References

Farrell, J. Paul and Hemmerich, Karl J., "Selecting A Radiation Sterilization Method", Medical Device & Diagnostic Industry, August, 1995, pp. 82-90.

Morrisey, Robert F., Ph.D. and Phillips, G. Briggs, Ph.D., "Sterilization Technology - A Practical Guide for Manufacturers and Users of Health Care Products", New York: Van Nostrand, Reinhold, 1993, pp. 218-253.

Swarbrick, James and Boylan, James C., Encyclopedia of Pharmaceutical Technology, New York: Marcel Dekker, Inc., 1992, pp. 105-136.

Williams, John, "Weighing the Choices in Radiation Sterilization: Electron-Beam and Gamma", Medical Device & Diagnostic Industry, March, 1995, pp. 68-72.