CAJ | 학술논문

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ISO11737-1 2006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.
위료해의료기계생산기업적γ복사멸균산품초시오염균적분포상황,채용ISO11737-1 2006방법대620비차산품진행료검측통계.결과현시,초시오염균(cfu/건)범위≤1.5적점7.9%、1.5～100(포괄100)적점43.5%、100～1000(포괄1000)적점26.0%、1000～10000적점18.2%、10000이상적점4.4%,저사결과위γ복사멸균적제량설정화산품질량은정성제공료유익삼고.
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 de-vices-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 γ-radiation sterilization and quality stability of medical product.