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Volume 14 Issue 6
Nov.  2023
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HAO Ye, WANG Hao, LI Jiage. Interpretation On Sectoral Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 3: General Requirements for Data Annotation[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(6): 1185-1188. DOI: 10.12290/xhyxzz.2023-0463
Citation: HAO Ye, WANG Hao, LI Jiage. Interpretation On Sectoral Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 3: General Requirements for Data Annotation[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(6): 1185-1188. DOI: 10.12290/xhyxzz.2023-0463
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Interpretation On Sectoral Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 3: General Requirements for Data Annotation

  • National Institutes for Food and Drug Control, Beijing 100050, China

Funds: 

Key Technology Fund of National Institutes for Food and Drug Control GJJS-2022-3-1

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  • Corresponding author:

    LI Jiage, E-mail: lijiage@nifdc.org.cn

  • Received Date: October 06, 2023
  • Accepted Date: October 29, 2023
  • Issue Publish Date: November 29, 2023
    Graphical Abstract
    • 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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    • References (18)
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