Effects of bioburden-recovery on radiation sterilization dose of medical devices

The aim is to evaluate the effects of bioburden-recovery on the radiation sterilization dose of various products based on the differences in the bioburden-recovery obtained using different experimental parameters. Three types of products including femoral stem, bone wax, and bipolar ball head were selected and subjected to bioburden-recovery tests using different testing standards. Further, the minimum irradiation sterilization dose of the products corresponding to different results of bioburden was obtained based on the ISO 11137-2: 2013 (Method 1) standard. The test results indicate that the different bioburden-recovery of the products lead to a difference in bioburden and sterilization dose, which directly affects the quality control of sterilization. (author)