Study on adaptation of radiation sterilization of 3M Steri-Drape~(TM)

Based on ISO11137 , bioburden of 3M Steri-DrapeTM and the sterilization dose were determined. Results indicted that the adjusted average bioburden was 3082.5cfu per device, verification dose was 12.6kGy and the minimum sterilization dose was 26.8kGy (SAL 10-6). The irradiated sample products were tested to verify properties of the package materials and biocompatibility of the device. Results showed that after the irradiation and accelerated aging test, the sample products and the package were qualified. The device remained sterile and no adverse response was found in cytotoxicity test, animal test and clinical applications.