摘要
旨在评估新型医疗器械中应用的呼吸面罩技术存在的问题,并提出相应的改进策略。首先,介绍呼吸面罩技术的发展背景和应用现状,并分析其在新型医疗器械中的重要性。其次,从患者体验的角度出发对呼吸面罩技术存在的问题进行评估,主要包括舒适性、可靠性和易用性等方面的问题。再次,从审评角度分析呼吸面罩产品技术要求中性能指标的制定。最后,提出呼吸面罩技术的改进策略,包括设计优化、材料改进和功能增强等方面。
This article aims to evaluate the problems of respiratory mask technology applied in new medical devices and propose corresponding improvement strategies.Firstly,the development background and application status of respiratory mask technology were introduced,and its importance in new medical devices was analyzed.Secondly,from the perspective of patient experience,the problems of breathing mask technology were evaluated,mainly including comfort,reliability,and ease of use.Once again,from the perspective of evaluation,the formulation of performance indicators in the technical requirements of respiratory mask products was analyzed.Finally,this article proposes improvement strategies for respiratory mask technology,including design optimization,material improvement,and functional enhancement.
作者
张梅
柴谦
王晓晨
杜旭
刘凤林
楚姗姗
ZHANG Mei;CHAI Qian;WANG Xiao-chen;DU Xu;LIU Feng-lin;CHU Shan-shan(Shandong Center for Food and Drug Evaluation and Inspection,Shandong Jinan 250013)
出处
《中国医疗器械信息》
2024年第7期14-17,共4页
China Medical Device Information
关键词
新型医疗器械
呼吸面罩技术
问题评估
改进策略
new medical devices
respiratory mask technology
problem assessment
improvement strategy