摘要
医用防护口罩作为国家重点监管医疗器械品种,该产品质量安全获高度重视。文章从医用防护口罩产品概况、产品标准关键项目解读,以及对2013年以来该产品国家医疗器械抽检情况进行分析,对于集中的不合格项目过滤效率和密合性分别展开不合格原因分析,针对医用防护口罩生产企业提升产品质量及监管部门加强监督管理工作分别提出建议,旨在共同促进产业高质量发展。
As a national key regulatory medical device variety,medical protective masks have received high attention to product quality and safety.This article provides an overview of medical protective mask products,key items of product standards,and an analysis of the national medical device sampling inspection of this product since 2013.It analyzes the reasons for non conformities in the filtering efficiency and fit of centralized non conformities,and proposes suggestions for improving product quality for medical protective mask production enterprises and strengthening supervision and management by regulatory departments,intended to jointly promote high-quality industrial development.
作者
罗庆祥
曾志雄
袁秦
刘铭康
LUO Qing-xiang;ZENG Zhi-xiong;YUAN Qin;LIU Ming-kang(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510000)
出处
《中国医疗器械信息》
2023年第19期30-32,共3页
China Medical Device Information
关键词
医用防护口罩
质量
抽检
过滤效率
密合性
medical protective masks
quality
sampling inspection
filtering efficiency
fit
