行业标准《人工智能医疗器械 质量要求和评价 第3部分: 数据标注通用要求》解析

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

  • 摘要: 伴随机器学习技术的迭代升级,人工智能已成为医疗器械领域的新兴方向,尤其近年来发展迅速。国家药品监督管理局于2022年发布了行业标准YY/T 1833《人工智能医疗器械 质量要求和评价》系列标准,标志着我国已初步建立了人工智能医疗器械的标准体系。数据标注是人工智能医疗器械质控的重要环节,数据标注的规范化、标准化不仅是标准体系的重要方面,也决定了参考标准的准确性和可靠性,从而对数据集质量和产品质量产生重要影响。《人工智能医疗器械 质量要求和评价》第3部分为数据标注通用要求,其对人工智能医疗器械在数据标注环节的质量进行了要求,并对评价方法进行了规范。本文将对其重要内容进行解析,以期更好地开展产品质控,促进产品及行业高质量发展。

     

    Abstract: 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.

     

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