2020年湖北省医用口罩类产品监督抽检情况分析  

Analysis of the Supervision and Sampling of Medical Mask Products in Hubei Province in 2020

作　　者：吴欢 梅享林 WU Huan;MEI Xiang-lin(Hubei Medical Devices Quality Supervision and Test Institute,Hubei Wuhan 430075)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075

出　　处：《中国医疗器械信息》2023年第11期5-7,26,共4页China Medical Device Information

摘　　要：目的:通过医用口罩类产品监督抽检情况,分析医用口罩类产品在生产、质量检测方面出现的问题,为提升医用口罩质量及监管服务提供技术支持和参考。方法:依据湖北省监督抽检方案,根据医用口罩类产品相应的强制性行业标准和企业制定技术要求,对湖北省内抽检口罩产品进行检测。结果:2020年4月~12月医用口罩共抽检104批次产品,占总批次的35%,共有20批次不合格,占医用口罩批次的19%,不合格项目主要集中在口罩带和细菌过滤效率上。结论:本省医用口罩类产品存在一定的问题,企业应加强对产品质量的控制以及完善质量体系的建设。Objective:According to the supervision and sampling inspection of medical mask products,we analyze the problems of medical mask products in production and quality inspection,so as to provide technical support and reference for improving the quality of medical mask and supervision services.Methods:According to the supervision and sampling inspection scheme of Hubei Province,as well as the corresponding mandatory industry standards for medical mask products and the technical requirements formulated by enterprises,the random inspection mask products in Hubei Province are tested.Results:From April to December 2020,a total of 104 batches of medical masks were sampled,accounting for 35%of the total batch.A total of 20 batches were not qualified,accounting for 19%of the batch of medical masks.Non-conforming items are mainly medical mask straps and bacterial filtration efficiency.Conclusion:There are certain problems in medical mask products in this province,enterprises should strengthen the control of product quality and improve the construction of quality system.

关 键 词：医用口罩 监督抽检 质量 

分 类 号：TH771[机械工程—仪器科学与技术]