医疗器械厂家如何有效地执行灭菌标准Howdo.PDF

医疗器械厂家如何有效地执行灭菌标准？经验分享 How do medical equipment manufacturers carry out sterilization standard in a effective way Experience sharing 徐星岗 南京微创医学 威海，2015-06-12 Xu Xinggang Nanjing Micro-techl Weihai, June 12, 2015 灭菌经验分享 Sterilization experience sharing 演讲内容 Content of speech  辐射灭菌国家行业标准信息：医疗器械辐射灭菌验证剂量 实验和灭菌剂量审核的抽样计划  National industrial standard information of radiation sterilization : verification dose test on radiation sterilization of medical equipment and sampling plan for check on sterilization dose  如何有效执行灭菌标准？经验分享  How to carry out the sterilization standard effectively? - experience sharing 辐射灭菌行业标准信息 Industrial standard information of radiation sterilization  正在起草中的辐射灭菌行 业标准：医疗器械辐射灭 菌验证剂量实验和灭菌剂 量审核的抽样计划  The industrial standard for radiation sterilization under draft : verification dose test on radiation sterilization of medical equipment and sampling p l a n f o r c h e c k o n sterilization dose 表1 方法1：验证剂量实验的抽样计划 Table 1 Method 1: Sampling Plan for Verification Dose Test 无菌试验阳性数量 抽样计划 Positive quantity of sterility AQL=0.83%LTPD=5.49% test