Journal of Radiation Research and Radiation Processing ›› 2019, Vol. 37 ›› Issue (6): 42-47.doi: 10.11889/j.1000-3436.2019.rrj.37.060401

• RADIATION TECHNOLOGY APPLICATION • Previous Articles     Next Articles

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

ZHANG Yue()   

  1. Beijing Research Center for Radiation Application, Beijing 100015, China
  • Received:2019-07-19 Revised:2019-09-02 Accepted:2019-09-02 Online:2019-12-20 Published:2019-12-23
  • About author:ZHANG Yue(female)was born in March 1982, and graduated from the College of Applied Arts and Sciences of Beijing Union University in 2004, majoring in biotechnology. Now she engages in radiation sterilization of medical devices as an assistant professor, E-mail: daicy0312@163.com

Abstract:

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.

Key words: Irradiation, Sterilization dose, Recovery, Bioburden, Medical devices

CLC Number: 

  • R187