Sponsoring Society and Committee: IEEE Engineering in Medicine and Biology Society/Standards Committee (EMB/Stds Com)
IEEE P2801
Title:Recommended Practice for the Quality Management of Datasets for Medical Artificial Intelligence
Scope:The recommended practice identifies best practices for establishing a quality management system for datasets used for artificial intelligence medical device.
The recommended practice covers a full cycle of dataset management, including items such as but not limited to data collection, transfer, utilization, storage, maintenance and update.
The recommended practice recommends a list of critical factors that impact the quality of datasets, such as but not limited to data sources, data quality, annotation, privacy protection, personnel qualification/training/evaluation, tools, equipment, environment, process control and
documentation.
IEEE P2802
Title: Standard for the Performance and Safety Evaluation of Artificial Intelligence Based Medical Device: Terminology
Scope: 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.
Working Group
P2801 PAR
P2802 PAR
Note:
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