Abstract：Objective To analyze the risk of surgical robots in clinical use, and study the corresponding quality evaluation methods, so as to provide references for strengthening the quality evaluation and risk control of surgical robots. Methods Combined with the product problems found in the actual inspection work, the adverse event feedback of the clinical application of surgical robot products at home and abroad was analyzed, and the preventive measures and rectification methods of the main risk points were analyzed from the level of instrument quality evaluation. Results As a special type of high-risk medical electrical equipment or medical electrical system, the safety and compliance of the system should be considered in all aspects in the product design stage, especially in the selection of key components such as power supply units and cables. The design process should fully consider the comprehensive application environment. Conclusion Through the risk analysis in the verification testing of the surgical robot, the quality control methods corresponding to the quality risk points are explored, and the insights for the future quality evaluation and supervision of such products are put forward.
郝烨，孟祥峰，苏宗文，李澍，张超，李佳戈. 手术机器人风险分析及质量评价探讨[J]. 中国医疗设备, 2020, 35(9): 22-25.
HAO Ye, MENG Xiangfeng, SU Zongwen, LI Shu, ZHANG Chao, LI Jiage. Discussion on Risk Analysis and Quality Evaluation of Surgical Robot. China Medical Devices, 2020, 35(9): 22-25.
