Active PAR

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.

Sponsor Committee
EMB/Stds Com - Standards Committee
Learn More
Status
Active PAR
PAR Approval
2018-12-05

Working Group Details

Society
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
Contact
Working Group Chair
Hao Wang

P2801

IEEE Draft Recommended Practice for the Quality Management of Datasets for Medical Artificial Intelligence

The recommended practice promotes quality management activities for datasets used for artificial intelligence medical device(AIMD). The document highlights quality objective for dataset responsible organizations. The document describes control of records during the life cycle of datasets, including but not limited to data collection, annotation, transfer, utilization, storage, maintenance, update, 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.

Learn More

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No Superseded Standards
No Inactive-Withdrawn Standards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

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