Active Standard

IEEE 2802-2022

IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology

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
Active Standard
PAR Approval
Board Approval

Working Group Details

IEEE Engineering in Medicine and Biology Society
Learn More
Sponsor Committee
EMB/Stds Com - Standards Committee
Learn More
Working Group
AIMDWG - Artificial Intelligence Medical Device Working Group
Learn More
IEEE Program Manager
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.


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.

Learn More

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No Superseded Standards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No Inactive-Withdrawn Standards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

Sign up for our monthly newsletter to learn about new developments, including resources, insights and more.