基于国家监督抽验结果的药物熏蒸治疗设备现存问题探讨  

Discussion on the Existing Problems of Drug Fumigation Treatment Equipment Based on National Supervision and Sampling Results

作　　者：钱学波 张海明[1] 高山[1] QIAN Xuebo;ZHANG Haiming;GAO Shan(Tianjin Medical Devices Quality Supervision and Testing Center, Tianjin 300384, Chin)

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384

出　　处：《中国医疗设备》2018年第5期155-157,169,共4页China Medical Devices

摘　　要：为了进一步提升药物熏蒸治疗设备的产品质量,本文通过对2016年"药物熏蒸治疗设备"国家监督抽验中产品不合格项目的统计分析和对最新发布行业标准的符合性研究,得出了设备不合格项目主要集中在外部标记、随机文件、指示灯和按钮3个方面,以及现阶段行业标准的符合率较低的结果。为进一步提升此类设备的产品质量,规范生产提供了参考。In order to further improve the product quality of the drug fumigation treatment equipment, the statistical analysis of the items that were not qualified in the national supervision of the drug fumigation treatment equipment in 2016 was made, and the conformity of the latest industry standard was studied in this paper. It was concluded that the unqualifed items were mainly focused on the outside marking, accompanying documents, as well as indicator lights and push-buttons. Furthermore, the conformity of the industry standard was presently low now. This study provides a reference for improving the product quality and standardizing the manufacture process.

关 键 词：药物熏蒸治疗设备 医疗器械国家监督抽验 蒸汽发生器 开放式治疗设备 封闭式治疗设备 

分 类 号：R197.3[医药卫生—卫生事业管理]