Abstract: This paper aims to interpret the research background,specific requirements,and evaluation methods of the medical device industry standard YY/T 1833.4-2023,Artificial Intelligence Medical Devices — Quality Requirements and Evaluation — Part 4:Traceability.By reviewing domestic and international regulatory documents and standards on artificial intelligence medical devices and medical software,a literature investigation was conducted using traceability as the keyword.The connotation of traceability was comprehensively summarized,and the main contents of this standard were analyzed in conjunction with the product research,development,and verification process,with the expectation of deepening the understanding and implementation of the traceability standard for artificial intelligence medical devices and promoting the standardized and high-quality development of the industry.The traceability of artificial intelligence medical devices needs to be integrated into the quality management of the entire life cycle of medical devices,with particular attention to three aspects:design and development,clinical use,and algorithm updates in the future.