医疗器械包类产品技术审评规范探讨  

Instruction of the Technical Evaluation for Medical Devices Kits

作　　者：仲志真 钱虹[1] 储云高[1] 戴嗣卫 汪泽[1] 朱颖峰[1] 孙旭颖[1] 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海市200020

出　　处：《中国医疗器械杂志》2013年第3期213-217,共5页Chinese Journal of Medical Instrumentation

摘　　要：近年来,医疗器械包类产品发展迅速。如何在安全、有效的两大原则基础上使得器械包的技术审评更加完善,使得器械包在上市后更加规范、有序成为技术审评需要考虑的问题。该文通过对这类产品的生产、管理分类和注册现状进行分析,结合我国现有的法规文件和相关标准,对技术审评有关问题进行了探讨。Recent years, the development of medical devices kits is rapid. How to make the technical evaluation of medical devices kits more perfect bases on the two major principles of safe and effective, and to make kits in the market more normative and orderly, these issues for technical evaluation have to be considered. This article makes a study on current situation of production, classification of management and registration status, combined with existing regulations and related standards, and discusses technical evaluation related issues.

关 键 词：器械包 二次灭菌 组件 技术审评 

分 类 号：TH77[机械工程—仪器科学与技术]