呼吸系统过滤器审评要点分析

Analysis on the Evaluation of Breathing System Filter

文章对呼吸系统过滤器产品作简单介绍,并从产品管理类别及分类编码,产品结构组成及原材料控制,生物相容性评价,产品技术要求,临床对比分析等方面列出该产品在注册审评阶段的审评要求、关注内容。

This paper gave a brief introduction to the breathing system filter product,and listed the key points and concerns of the product in the technical evaluation processfrom aspects such as product management categories and classification codes,product structure composition and raw material control,biocompatibility evaluation,product technical requirements,clinical comparative analysis,etc.