辐射灭菌剂量设定方法简介  

Introduction of Establishing the Radiation Sterilization Dose Methods

作　　者：姜帆 李竹 李双 杨华 JIANG Fan;LI Zhu;LI Shuang;YANG Hua(Liaoning Provincial Certification and Evaluation Institute,Liaoning Shenyang 110030)

机构地区：[1]辽宁省认证审评院,辽宁沈阳110030

出　　处：《中国医疗器械信息》2021年第7期8-10,共3页China Medical Device Information

摘　　要：研究辐射灭菌剂量设定方法,为无菌医疗器械生产企业辐射灭菌提供参考。通过研习辐射灭菌标准,对辐射剂量设定的三种方法及原理进行介绍,并以利用产品生物负载信息来进行剂量设定方法为例,对辐射剂量设定具体过程进行详细说明。结果认为,合理设定灭菌剂量是辐射灭菌的关键环节,医疗器械生产企业应根据产品特性及所需达到的无菌保证水平等因素,选择适宜剂量设定方法,通过实验验证并确定最终灭菌剂量。This article aims to study the method of radiation sterilization dose setting,thus offer reference for aseptic medical device manufacturers.Based on standard study of radiation sterilization,this article describes three setting methods of sterilization dose,and explains the specific procedure by taking dose setting using bioburden information as an example.The result shows that setting the appropriate dose is the key point for radiation sterilization.Medical device manufacturers should choose appropriate dose setting method according to product features and assured sterility level as required.The final sterilization dose is determined by experimental verification.

关 键 词：无菌医疗器械 辐射灭菌 剂量设定 

分 类 号：R187.4[医药卫生—流行病学]