呼吸面罩产品技术审评关注点探讨  

Discussion on Technical Evaluation Attentions of Breathing Mask

作　　者：柴谦 刘凤林 王晓晨 杜文新 张梅 杜旭 楚姗姗 CHAI Qian;LIU Feng-lin;WANG Xiao-chen;DU Wen-xin;ZHANG Mei;DU Xu;CHU Shan-shan(Shandong Center for Food and Drug Evaluation and Inspection,Shandong Jinan 250000)

机构地区：[1]山东省食品药品审评查验中心,山东济南250000

出　　处：《中国医疗器械信息》2024年第5期7-9,共3页China Medical Device Information

摘　　要：呼吸面罩是患者进行无创呼吸机通气时气体进入患者体内的重要通道。文章基于相关产品的审评经验积累并结合《呼吸面罩注册审查指导原则》的编写工作对呼吸面罩产品在技术审评中的主要关注点进行解析,包括主要性能指标、生物相容性评价、产品消毒灭菌研究等内容,以期为呼吸面罩产品的注册申报及技术审评提供参考。The breathing mask is an important channel for the gas to enter the body during the patient’s non-invasive ventilator ventilation.Based on the accumulation of experience in the evaluation of breathing mask products and the compilation of the Guiding Principles for the Technical Review of Breathing Mask,this study analyzed the main attentions of breathing mask products in the technical evaluation.Including the main performance indicators,biocompatibility evaluation,product disinfection and sterilization research,etc.In order to provide reference for the registration and technical evaluation of breathing mask products.

关 键 词：呼吸面罩 产品技术要求 生物相容性评价 技术审评关注点 

分 类 号：TH789[机械工程—仪器科学与技术]