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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

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




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WG Officers

Hao Wang,

Vice Chair

Chair of subgroup P2801

Hao Wang,

Chair of subgroup P2802

Xiangfeng Meng,


Ziye Yan,

Staff Liason

Tom Thompson,

Meng Zhao,

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