Medical Radiology and Radiation Safety. 2012. Vol. 57. No. 5. P. 66-71
RADIATION PHYSICS, TECHNOLOGY AND DOSIMETRY
V.V. Kalashnikov, L.A. Naumova, E.V. Rabinkova, O.V. Shishkova
Sterility of Medical Devices after Irradiation and Sterility Test in A.I. Burnazyan FMBC in 2007-2009 years
Burnasyan Federal Medical Biophysical Center of FMBA, Moscow, Russia, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Abstract
Purpose: To determine the sterility of medical devices that have passed irradiation and sterility test in Burnazyan FMBC.
Material and methods: Measurement presterilization contamination and sterility test sample production batch of products are held in FMBC methods established for the state supervision over the production of radiation-sterilized products, taking into account the species composition of micro flora, which gave rise during incubation, and if there is evidence that sterilization in approved production batch mode.
Results: The direct measurement of acceptance microbiological contamination presterilization, sterilization and sterility test were parts of the production of sterile products. Actually received the product to be sterilized with contamination presterilization 104-105 CFU. It is for these major items is set dose products in the series. The probability of presence of microorganisms capable of division in medical products, which passed in 2007-2009 years of exposure and tests for sterility in FMBC, less than 1x10-6.
Conclusion: The quality of sterilization products irradiated in FMBC beyond the quality of sterilization of products in health care settings. If the mode of sterilization approved, for direct microbiological acceptance of goods of an opportunity to customize the incubation period - seven days and a single medium, provided that it is universal for the cultivation of aerobic and anaerobic bacteria.
Key words: sterilization, medical products, quality of sterilization, test for sterility, presterilization contamination