This standard is aimed at establishing concepts and terminology for the performance and safety evaluation of artificial intelligence medical device, which covers basic technology, dataset, quality characteristics, quality evaluation and application scenario. The annex further provides basic equations for quality evaluation purpose.
- Sponsor Committee
- EMB/Stds Com - Standards Committee
Learn More About EMB/Stds Com - Standards Committee - Status
- Active Standard
- PAR Approval
- 2018-12-05
- Board Approval
- 2022-12-03
- History
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- Published:
- 2023-05-05
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
Learn More About IEEE Engineering in Medicine and Biology Society - Sponsor Committee
- EMB/Stds Com - Standards Committee
Learn More About EMB/Stds Com - Standards Committee - Working Group
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AIMDWG - Artificial Intelligence Medical Device Working Group
Learn More About AIMDWG - Artificial Intelligence Medical Device Working Group - IEEE Program Manager
- Jiajia Liu
Contact Jiajia Liu - Working Group Chair
- Hao Wang
Other Activities From This Working Group
Current projects that have been authorized by the IEEE SA Standards Board to develop a standard.
No Active Projects
Standards approved by the IEEE SA Standards Board that are within the 10-year lifecycle.
2801-2022
IEEE Recommended Practice for the Quality Management of Datasets for Medical Artificial Intelligence
Promoted in this recommended practice are quality management activities for datasets used for artificial intelligence medical devices (AIMD). The document highlights quality objectives for organizations responsible for datasets. The document describes control of records during the lifecycle of datasets, including but not limited to data collection, annotation, transfer, utilization, storage, maintenance, updates, retirement, and other activities. The document emphasizes special consideration for the dataset quality management system, including but notnlimited to responsibility management, resource management, dataset realization, and quality control.
These standards have been replaced with a revised version of the standard, or by a compilation of the original active standard and all its existing amendments, corrigenda, and errata.
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These standards are removed from active status through an administrative process for standards that have not undergone a revision process within 10 years.
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