Abstract:Objective To study the essential performance of electrical safety and electromagnetic compatibility evaluation of
ventricular assist device (VAD), to provide technical support for quality assurance. Methods Through the analysis and research
of general safety standards, electromagnetic compatibility standards and product performance, the basic performance of VAD
was determined, and the evaluation method was analyzed. Results General standard analysis concluded that the performance of
VAD (including rotational speed, flow, power, flow characteristics, anti-vibration ability, sealing, hemolysis requirements, starting
performance, etc.) and control accuracy (including rotational speed, flow, power, etc.) should be taken as the indicators of basic
performance evaluation, and the performance of alarm and auxiliary devices should be taken as the indicators of basic performance
evaluation. Conclusion Through standard analysis and product research, suggestions and methods are put forward to determine the
basic performance of VAD, which lays a research foundation for the inspection and detection of such devices. At the same time, it has
reference significance for the basic performance research of other devices.
王权,李澍,李佳戈. 心室辅助装置基本性能研究[J]. 中国医疗设备, 2023, 38(8): 6-10.
WANG Quan, LI Shu, LI Jiage. Study on Essential Performance of Ventricular Assist Device. China Medical Devices, 2023, 38(8): 6-10.