Abstract:With the support of a series of policies, the medical robot industry in China has been developing rapidly, and has been widely applied in clinical diagnosis and treatment. It has shown great advantage in the field of surgical treatment and postoperative rehabilitation. However, the medical robot is a complex medical device system which integrates multi-disciplinary mechanism and various technologies, resulting in underlying risks. Development of special technical standards is needed to guide the industry, so as to promote high end products. This paper describes the current situation of the standards related to medical robots, analyzes the need for medical robot standardization, analyzes the general definition, reliability, usability, system integration, component level performance and test method, product level performance and safety, propose the design idea of the standard system.This paper may provide reference for the standardization in the field of medical robots in China.
张超,孟祥峰,王权,王浩,唐桥虹,李佳戈. 医用机器人标准体系研究[J]. 中国医疗设备, 2020, 35(9): 4-8.
ZHANG Chao, MENG Xiangfeng, WANG Quan, WANG Hao, TANG Qiaohong, LI Jiage. Research on the Standard System of Medical Robot. China Medical Devices, 2020, 35(9): 4-8.