Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets

Datasets, as an important resource for artificial intelligence medical device industry, have been placed under medical device supervision. National Medical Products Administration (NMPA) has published a sectoral standard named YY/T 1833.2-2022 Artificial Intelligence Medical Device-Quality Requireme...

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Main Authors: WANG Hao, MENG Xiangfeng, HAO Ye, LI Jiage, LI Jingli
Format: Article
Language:zho
Published: Editorial Office of Medical Journal of Peking Union Medical College Hospital 2023-11-01
Series:Xiehe Yixue Zazhi
Subjects:
Online Access:https://xhyxzz.pumch.cn/en/article/doi/10.12290/xhyxzz.2023-0464
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author WANG Hao
MENG Xiangfeng
HAO Ye
LI Jiage
LI Jingli
author_facet WANG Hao
MENG Xiangfeng
HAO Ye
LI Jiage
LI Jingli
author_sort WANG Hao
collection DOAJ
description Datasets, as an important resource for artificial intelligence medical device industry, have been placed under medical device supervision. National Medical Products Administration (NMPA) has published a sectoral standard named YY/T 1833.2-2022 Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirement for Datasets to guide dataset quality evaluation. This standard describes dataset requirements for documentation and quality measures, proposes evaluation methods, and helps dataset producers enhance quality control from the source. It would benefit clinical agencies in dataset construction and better meet industry need. This article introduces the background and key points of the standard, in order to better guide the applications in artificial intelligence medical device industry.
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spelling doaj.art-87f8c590de174a7ab07f6ce5defde1412023-12-04T02:34:10ZzhoEditorial Office of Medical Journal of Peking Union Medical College HospitalXiehe Yixue Zazhi1674-90812023-11-011461180118410.12290/xhyxzz.2023-0464Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for DatasetsWANG HaoMENG XiangfengHAO YeLI JiageLI JingliDatasets, as an important resource for artificial intelligence medical device industry, have been placed under medical device supervision. National Medical Products Administration (NMPA) has published a sectoral standard named YY/T 1833.2-2022 Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirement for Datasets to guide dataset quality evaluation. This standard describes dataset requirements for documentation and quality measures, proposes evaluation methods, and helps dataset producers enhance quality control from the source. It would benefit clinical agencies in dataset construction and better meet industry need. This article introduces the background and key points of the standard, in order to better guide the applications in artificial intelligence medical device industry.https://xhyxzz.pumch.cn/en/article/doi/10.12290/xhyxzz.2023-0464yy/t 1833.2-2022artificial intelligencemedical devicedata qualitydataset
spellingShingle WANG Hao
MENG Xiangfeng
HAO Ye
LI Jiage
LI Jingli
Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets
Xiehe Yixue Zazhi
yy/t 1833.2-2022
artificial intelligence
medical device
data quality
dataset
title Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets
title_full Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets
title_fullStr Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets
title_full_unstemmed Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets
title_short Interpretation on the Standard Artificial Intelligence Medical Device-Quality Requirements and Evaluation-Part 2: General Requirements for Datasets
title_sort interpretation on the standard artificial intelligence medical device quality requirements and evaluation part 2 general requirements for datasets
topic yy/t 1833.2-2022
artificial intelligence
medical device
data quality
dataset
url https://xhyxzz.pumch.cn/en/article/doi/10.12290/xhyxzz.2023-0464
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AT mengxiangfeng interpretationonthestandardartificialintelligencemedicaldevicequalityrequirementsandevaluationpart2generalrequirementsfordatasets
AT haoye interpretationonthestandardartificialintelligencemedicaldevicequalityrequirementsandevaluationpart2generalrequirementsfordatasets
AT lijiage interpretationonthestandardartificialintelligencemedicaldevicequalityrequirementsandevaluationpart2generalrequirementsfordatasets
AT lijingli interpretationonthestandardartificialintelligencemedicaldevicequalityrequirementsandevaluationpart2generalrequirementsfordatasets