浅谈无源植入性医疗器械货架寿命的验证  

Discussion on Verification for Shelf Life of Non-active Implantable Medical Device

作　　者：贾健雄[1] 

机构地区：[1]国家食品药品监督管理局医疗器械技术审评中心,北京100044

出　　处：《中国医疗器械信息》2011年第11期14-17,共4页China Medical Device Information

摘　　要：无源植入性医疗器械在指定的货架寿命内保持预期性能是保证其安全、有效使用的重要前提条件。然而,货架寿命的验证是一项复杂而漫长的工作。本文针对无源植入性医疗器械货架寿命验证过程中的主要流程、验证内容及注意事项进行论述,建议生产企业认真分析影响医疗器械货架寿命的各类因素,选择适当的检测方法和检测项目。Non-active implantable medical device keeps the expected performance in the specified shelf life is one of the important prerequisites for ensuring the safe and effective use.But,the verification for shelf life is a long and complex work.This article discusses on the process,methods and matters needing attention about the verification for shelf life of non-active implantable medical device,suggests medical device manufacturers to pay attention to analyzing the factors which can influence the shelf life data,and selecting the appropriate test methods and test items.

关 键 词：医疗器械 货架寿命 验证 注册 

分 类 号：R197[医药卫生—卫生事业管理]