γ辐射灭菌医疗器械初始污染菌的检测、统计与分析  

Determination, statistics, and analysis of initially contaminated microorganisms on medical devices treated by γ-radiation sterilization

作　　者：丛丽红[1] 朱南康[1] 滕维芳[1] 

机构地区：[1]苏州大学辐照技术研究所,苏州215200

出　　处：《辐射研究与辐射工艺学报》2009年第6期374-376,共3页Journal of Radiation Research and Radiation Processing

摘　　要：为了解医疗器械生产企业的γ辐射灭菌产品初始污染菌的分布状况,采用ISO11737-12006方法对620批次产品进行了检测统计。结果显示,初始污染菌(cfu/件)范围≤1.5的占7.9%、1.5～100(包括100)的占43.5%、100～1000(包括1000)的占26.0%、1000～10000的占18.2%、10000以上的占4.4%,这些结果为γ辐射灭菌的剂量设定和产品质量稳定性提供了有益参考。In order to investigate the influence of initially contaminated microorganisms on medical devices for treatment by γ-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 product batches share is 7.9%, 43.5%, 26.0%, 18.2 % and 4.4% with an average bioburden of ≤1.5, 1.5-100, 100-1000, 1000-10000 and 〉10000 cfu/piece, respectively. These data are helpful to the dose decision for 7-radiation sterilization and quality stability of medical product.

关 键 词：γ辐射灭菌 医疗器械 初始污染菌 灭菌剂量 

分 类 号：TL99[核科学技术—核技术及应用] R197.39[医药卫生—卫生事业管理]