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 not limited to responsibility management, resource management, dataset realization, and quality control.
- Standards Committee
- EMB/Stds Com - Standards Committee
Learn More - Status
- Active Standard
- PAR Approval
- 2018-12-05
- Board Approval
- 2022-05-13
- History
-
- Published:
- 2022-07-05
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
Learn More - Standards Committee
- EMB/Stds Com - Standards Committee
Learn More - Working Group
-
AIMDWG - Artificial Intelligence Medical Device Working Group
Learn More - IEEE Program Manager
- Jiajia Liu
Contact - 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.
P2802
Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology
The standard establishes terminology used in artificial intelligence medical device, including definitions of fundamental concepts and methodology that describe the safety, effectiveness, risks and quality management of artificial intelligence medical device. The standard provides definitions using the following forms, such as but not limited to literal description, equations, tables, figures and legends. The standard also establishes a vocabulary for the development of future standards for artificial intelligence medical device.
Standards approved by the IEEE SA Standards Board that are within the 10-year lifecycle.
No Active Standards
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.
No Superseded Standards
These standards have been removed from active status through a ballot where the standard is made inactive as a consensus decision of a balloting group.
No Inactive-Withdrawn Standards
These standards are removed from active status through an administrative process for standards that have not undergone a revision process within 10 years.
No Inactive-Reserved Standards