应用ISO10993-7:2008确定医疗器械中环氧乙烷残留限量

Application of ISO10993-7:2008 to Determine Ethylene Oxide Residual Limits in medical Devices

医疗器械的环氧乙烷(EO)灭菌因其操作简便、灭菌效果好、对所灭菌器械性能影响较小等优点,多年来深受医疗器械生产企业的青睐。同时,灭菌后器械中残留的EO对人体健康的影响也是人们一直关注的话题。ISO/TC 194于2008年推出新版ISO 10993-7,用于替代ISO 10993-7:1995。与前版标准相比,新标准在内容上进行了较大改动,将短期接触类器械的EO允许限量由20mg修改为4mg,将2-氯乙醇允许限量由12mg修改为9mg;持久接触器械的ECH平均日剂量由2mg/d改为0.4mg/d,一生最大剂量由50g改为10g。同时丰富了标准的内容,应用可沥滤物限量方法及风险评价的理念来对器械中残留EO的安全性进行综合评价等。与ISO 10993-7:1995相比,新版标准的信息量大,可操作性强,更适于指导我们对器械中残留EO的风险进行评价和控制。

In recent years,ethylene oxide（EO） has been adopted by manufacturer for sterilization of medical devices because of easy operation,effective sterilization and less impact on the performance of medice devices.Meanwhile,Impact by residue in the EOsterilizing devices on human health has long been a topic of concern.In 2008,ISO/TC 194 released new edition of ISO 10993-7 in order to replace ISO 10993-7：1995.Great changes have been taken place in the content compared to the previous edition.The allowable limits of EO by short-term exposed device has been changed from 20mg to 4mg,ECH has been changed from 12mg to 9mg.For permanent exposed devices,the average daily dose of ECH to patient has changed from 2mg/d to 0.4mg/d.Furthermore,the maximum ECH dose has also changed from 50g to 10 g in a life time.At the same time,ISO10993-7：2008 also adopted the concepts of limits for leachable substances and took risk evaluation concepts to assess the safety of EO residuals in the related medical devices.In contrast to the former edition,ISO10993-7：2008 has been richer in content and easier to operate.It is therefore much more applicable for us to control the safety of EO residuals in medical devices.