医疗器械产品工艺验证解析  

Process Verification Analysis of Medical Device Products

作　　者：宋驰骋 陈鑫 李若然 顾代春 SONG Chi-cheng;CHEN Xin;LI Ruo-ran;GU Dai-chun(Capital Bio Technology(Chengdu)Co.,Ltd.,Sichuan Chengdu 611135)

机构地区：[1]成都博奥晶芯生物科技有限公司,四川成都611135

出　　处：《中国医疗器械信息》2024年第13期63-65,72,共4页China Medical Device Information

摘　　要：目前,国内外医疗器械生产厂家的工艺验证主要是参考药品的验证方法,但医疗器械和药品的产品特征是不同的,因此,不同的医疗器械产品需要根据产品特征、风险等级、预期用途来制定不同的验证方案。文章着重介绍了医疗器械工艺验证的概念、内容和实施方法,以及如何通过工艺验证来确保医疗器械在批量化生产过程中的安全性和有效性。At present,The process verification of Medical Device Manufacturers is reference Drugs verification.However,the product characteristics of Medical Devices and Drugs are different.So,different Medical Device products need to according the product characteristics,risk,and intended use to making different validation plan.This article will introduce the concept,content and implementation methods of process verification for Medical Devices,And how to ensure the safety and effectiveness of Medical Devices in the mass production through process verification.

关 键 词：医疗器械 工艺验证 验证内容 验证实施 

分 类 号：R197.39[医药卫生—卫生事业管理]