医疗产品辐照灭菌剂量设定中初始污染菌回收率研究  

STUDY ON INITIAL CONTAMINATING BACTERIA AND THEIR RECOVERY RATE DURING SETTING DOSAGE FOR RADIATION STERILIZATION OF MEDICAL PRODUCTS

作　　者：曹晓蕴[1] 刘清芳[1] 朱旭[1] 张同成[1] 

机构地区：[1]苏州大学放射医学与公共卫生学院,苏州215007

出　　处：《中国消毒学杂志》2005年第4期427-429,共3页Chinese Journal of Disinfection

摘　　要：采用ISO11737-1标准方法检测辐照灭菌前初始污染菌及回收率,以便设定医疗产品辐照灭菌剂量.结果,5种医疗产品校正前,初始污染菌范围525～2688 cfu/件,验证剂量(SAL 10-2)范围10.1～12.4 kGy,最低灭菌剂量(SAL 10-6)范围23.9～26.6 kGy;校正后染菌数范围为725～3387 cfu/件,验证剂量为10.6～12.7 kGy,最低灭菌剂量为24.5～26.9 kGy.染菌回收率范围为67.02～79.58%,校正因子1.26～1.49. 结论,经过统计分析,试验校正前后回收率有显著差异(P＜0.05).ISO11737 - 1 standard method was used to examine the initial contaminating bacteria before radiation sterilization and their recovery rates in order to setting dosage for radiation sterilization of medical products. Results： The initial contaminating bacterial count of 5 medical products ranged 525～2688 cfu/piece before correction, the verification dosage （ SAL10^-2 ） ranged 10.1～12.4 kGy and the minimal sterilization dosage （ SAL10 ^-6 ） ranged 23.9～26.6 kGy. After corection, the contaminating bacterial count ranged 725～3387 cfu/piece, the verification dosage ranged 10.6～12.7 kGy and the minimal sterilization dosage ranged 24.5～26.9kGy. The recovery rate of contaminating bacteria ranged 67.02%～79.58% and the correction factor was 1.26～1.49. Conclusion： Statistical analysis showed that the recovery rates before and after correction of the experiment were significantly different （ P 〈 0.05 ）.

关 键 词：辐照灭菌 初始污染菌 回收率:灭菌剂量 

分 类 号：R187[医药卫生—流行病学]