3MStreri-Drape^(TM)的辐照灭菌适应性的研究

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

摘要按照ISO111737标准进行3MStreri-DrapeTM初始污染菌检测,并依据ISO11137标准方法完成了辐照灭菌的剂量设定。初始污染菌数为3082.5cfu/件,验证剂量为12.6kGy(SAL10-2),最低灭菌剂量为26.8kGy(SAL10-6)。对经最低灭菌剂量辐照并完成老化试验后的产品又进行了包装材料性能、产品的生物学评估和临床应用等研究。结果表明,包装材料性能良好,产品无菌,细胞毒性、动物实验及临床应用均无不良反应。

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.