家用电子医疗器械标准体系研究

Research on Standard System of Home Use Electronic Medical Devices

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。

Abstract: Medical 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.