采用初始污染菌法设定医用敷料辐射灭菌剂量  

DETERMINATION OF RADIATION STERILIZATION DOSAGE FOR MEDICAL DRESSINGS USING INITIAL CONTAMINATINGBACTERIA METHOD

作　　者：张同成[1] 钟宏良[1] 王春雷[2] 时锡金 姜建平[2] 

机构地区：[1]苏州大学核医学院,苏州215007 [2]苏州大学辐照技术研究所

出　　处：《中国消毒学杂志》2002年第2期69-72,共4页Chinese Journal of Disinfection

摘　　要：为对医用敷料辐射灭菌剂量进行设定,采用ISO137附录方法1初始污染菌信息法,用校正因子校正初始污染菌数后,设定剂量并对灭菌剂量的有效性进行确认、结果,三批产品经过校正的初始污染菌数平均为1768 cfu/件,查其SAL 10－2所需辐照剂量为11．8kGy。以该剂量辐照100件样品,无菌试验检测无1阳性,说明该剂量可以接受,故查得其SAL10-6辐照剂量为25．9 kGy。In order lo determine the radiation sterilization dosage for medical dressings, the initial contaminating bacteria information method of method 1 in appendix of ISO 11137 was used.After the number of initial contaminating bacteria was corrected with corrected factor, a dosage was set and the effectiveness of the sterilization dosage was confirmed. The results showed that the corrected number of initial contaminating bacteria in 3 batches of products was 1768 cfu/sample in average and the required radiation dosage was 11.8 kGy according to SAL 10-2. After irradiation of 100 samples with this dosage, no one was positive in sterili zation test, indicating that this dosage is acceptable, therefore, the sterilization dosage accord ing to SAL 10-6 was 25.9 kGy.

关 键 词：辐照灭菌 灭菌剂量 初始污染菌数 医用敷料 

分 类 号：R187.4[医药卫生—流行病学]