医用口罩标准比对及医用口罩生产企业飞行检查常见问题浅析  

Comparison of Domestic Medical Mask Standards and Brief Analysis of the Problems Existing in the Flight Inspection of Medical Mask Manufacturers

作　　者：姜帆 王晓 JIANG Fan;WANG Xiao(Liaoning Center for Drug Evaluation and Inspection,Liaoning Shenyang 110036)

机构地区：[1]辽宁省药品审评查验中心,辽宁沈阳110036

出　　处：《中国医疗器械信息》2022年第19期6-8,131,共4页China Medical Device Information

摘　　要：近年来医用口罩产品质量受到持续关注。文章对国内医用口罩相关标准及技术指标进行比对,对医用口罩结构、原材料、生产工艺及省内行业现状进行介绍,结合2022年辽宁省医用口罩生产企业飞行检查情况,对生产管理、采购及文件管理部分出现问题进行分析,以供同类企业借鉴和参考。旨在帮助口罩生产企业提高质量意识,学习质量管理技能,持续产出符合预期用途和技术要求的口罩产品。In recent years,the quality of medical mask has been brought into sharp focus.This article compares domestic medical mask standards and specifications.The structure of mask,raw material,production process,status of industry inside the province is introduced.Based on flight inspection of medical mask manufacturers in Liaoning Province,problems existed in production management,purchasing and file management are analyzed,so as to provide references for the industries.This article aims to assist medical mask manufacturers to improve quality awareness and learn quality management skills,in order to produce qualified products consistent with intended use and technical requirements.

关 键 词：医用口罩 标准解读 飞行检查 问题分析 

分 类 号：TH789[机械工程—仪器科学与技术]