Study on Quality Control Evaluation of the Intravascular Ultrasound Optical Coherence
Tomography Synchronous Imaging System Under the New Standard System
WANG Quan, LI Shu, DANG Hui, HAO Ye, ZHANG Chao, LI Jiage
Institute for Medical Device Control, National Institutes for Food and Drug Control, Beijing 100050, China
Abstract：Objective To analyze the performance index of intravascular ultrasound optical coherence tomography (IVUS-OCT)
system and the risk of electrical safety system, and study the corresponding quality evaluation methods, so as to strengthen the quality
evaluation and risk control of effectiveness and safety of IVUS-OCT system. Methods Through the research on the performance
evaluation of imaging radius, resolution, and geometric position accuracy, combined with the daily inspection work, the test phantom
of performance evaluation was designed. Through the interpretation of safety regulation standards, the main risk points and evaluation
principles were analyzed from the perspective of quality evaluation. Results As a special high-risk medical electrical system, IVUSOCT
system should consider the safety and effectiveness of the system in all aspects from the product design stage. Special attention
should be paid to the protection of electric shock, overheating and electromagnetic compatibility. Conclusion Through the analysis of
the problems in the actual testing process of IVUS-OCT system the quality control methods corresponding to the quality risk points
are explored, and the ideas for the future detection and supervision of such products are put forward.
王权，李澍，党徽，郝烨，张超，李佳戈. 血管内超声光学相干断层同步成像系统在新标准体系下的质控评价研究[J]. 中国医疗设备, 2021, 36(8): 11-14.
WANG Quan, LI Shu, DANG Hui, HAO Ye, ZHANG Chao, LI Jiage. Study on Quality Control Evaluation of the Intravascular Ultrasound Optical Coherence
Tomography Synchronous Imaging System Under the New Standard System. China Medical Devices, 2021, 36(8): 11-14.
