家用电子医疗器械标准体系研究  

Research on Standard System of Home Use Electronic Medical Devices

作　　者：郑佳[1] 余新华[1] 何骏 高山[3] 李文 卓越 张昳冬 齐丽晶[3] 张赟[3] 钱学波 韩晓鹏 戎善奎[1] ZHENG Jia YU Xinhua HE Jun GAO shan LI Wen ZHUO Yue ZHANG Yidong QI Lijing ZHANG Yun QIAN Xuebo HAN Xiaopeng RONG Shankui(National Institutes for Food and Drug Control, Institute for Medical Device Standardization Administration, Beijing, 100050 Shanghai Testing ＆ Inspection Institute for Medical Devices, Shanghai, 201318 Tianjin Medical Device Quality Supervision and Testing Center, Tianjin, 300384 Beijing Institute of Medical Device Testing, Beijing, 101111)

机构地区：[1]中国食品药品检定研究院医疗器械标准管理研究所,北京市100050 [2]上海市医疗器械检测所,上海市201318 [3]天津市医疗器械质量监督检验中心,天津市300384 [4]北京市医疗器械检验所,北京市101111

出　　处：《中国医疗器械杂志》2017年第5期369-370,390,共3页Chinese Journal of Medical Instrumentation

摘　　要：面对医疗器械进"家"的大趋势,家用医疗器械的潜在风险日益凸显。该文通过系统介绍家用电子医疗器械产品种类以及国内外相关医疗器械标准现状,提出家用电子医疗器械标准体系建设思路,以期提升现有医疗器械标准体系的先进性和前瞻性,指导今后医疗器械标准立项工作,充分发挥标准在科技创新、产业发展中的导向和保障作用。Medica~ device going home is an inevitable trend, however, using these devices has potential safety risks. Through introducing the home use electronic medical device products and related medical device standards, this paper provides recommendations on construction of standard system for home use electronic medical devices, to improve the advancement of existing medical device standard system and guide future medical standardization work, to fully utilize standars＇s guiding and security role in the scientific and technological innovation, industrial development.

关 键 词：家用 医疗器械 标准体系 

分 类 号：F203[经济管理—国民经济]