Active Standard

IEEE 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 not limited to responsibility management, resource management, dataset realization, and quality control.

Sponsor Committee
EMB/Stds Com - Standards Committee
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Active Standard
PAR Approval
Board Approval

Working Group Details

IEEE Engineering in Medicine and Biology Society
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Sponsor Committee
EMB/Stds Com - Standards Committee
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Working Group
AIMDWG - Artificial Intelligence Medical Device Working Group
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IEEE Program Manager
Jiajia Liu
Working Group Chair
Hao Wang


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.

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No Active Standards
No Superseded Standards
No Inactive-Withdrawn Standards
No Inactive-Reserved Standards

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