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.
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Sep 30;41(5):369-370. doi: 10.3969/j.issn.1671-7104.2017.05.015.
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.
医疗设备走向家庭是必然趋势，然而，使用这些设备存在潜在安全风险。通过介绍家用电子医疗设备产品及相关医疗器械标准，本文提出了关于家用电子医疗设备标准体系建设的建议，以完善现有医疗器械标准体系的先进性，指导未来的医疗标准化工作，充分发挥标准在科技创新、产业发展中的引导和保障作用。
