Abstract：Objective To provide technical support for the quality control of artificial intelligent (AI)-based medical devices by
analyzing the definition and characteristics of the trustworthiness of such products, and studying the specific requirements, contents,
and evaluation methods. Methods The relevant regulatory documents, regulations, and standards in the field of AI-based medical
devices at home and abroad were investigated. Combined with the experience of actual inspection, the main risks and preventive
measures at the trustworthiness level were analyzed from the perspective of quality evaluation, and the specific connotation and
evaluation methods of trustworthiness were studied. Results The trustworthiness evaluation of AI-based medical devices was a
systematic evaluation involving product interface, functions and documents, which needed to be comprehensively evaluated from
multiple perspectives of controllability, robustness and privacy protection. Conclusion Trustworthiness is one of the important
characteristics of AI-based medical devices. The results of this study provide technical reference for the trustworthiness evaluation in
the future.
郝烨，王浩. 人工智能医疗器械可信赖性研究[J]. 中国医疗设备, 2023, 38(3): 56-60.
HAO Ye, WANG Hao. Research on Trustworthiness of Artificial Intelligence-Based Medical Devices. China Medical Devices, 2023, 38(3): 56-60.
