Interpretation On Sectoral Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 3: General Requirements for Data Annotation

With the upgrading of machine learning technology, artificial intelligence has become an emerging direction in the field of medical devices. Especially in recent years, it has developed rapidly. In 2022, the National Medical Products Administration released the industry standard YY/T 1833 "Artificial Intelligence Medical Device-Quality Requirements and Evaluation" series, marking the initial establishment of a standard system for artificial intelligence medical devices in China. The standardization of data annotation is not only an important part of the standard system, but also determines the accuracy and reliability of reference standards, which has a significant impact on the quality of the dataset and product quality. Part 3 of "Artificial Intelligence Medical Device-Quality Requirements and Evaluation", a general requirement for data annotation, proposes the quality requirements for artificial intelligence medical devices in the data annotation process and standardizes the evaluation methods. This paper highlights its important contents, in order to better carry out product quality control and promote high-quality development of products and industries.