Determination and analysis of bioburden on medical devices treated by radiation sterilization

In order to investigate the influence of initially contaminated microorganisms on medical devices for treatment by {gamma}-radiation sterilization, 620 batches of products collected from more than 50 manufactures in jiangsu, zhejiang, shanghai and so on have been inspected by use of iso11737-1 2006 sterilization of medical devices-microbiological methods-part 1. the results show that the rate is 7.9%, 43.5%, 26.0%, 18.2% 4.4% when batch average bioburden (cfu/piece) with group { 10 000 respectively. the result provided reference for establishing the sterilization dose and the parameters for radiation sterilization, moist heat sterilization and ethylene oxide sterilization and provided guidance for produce and quality control of medical devices. (authors)