IEEE 2801-2022

This recommended practice identifies best practices for establishing a quality management system for data sets used for artificial intelligence in medical devices. It covers a full cycle of data set management, including items, such as but not limited to, data collection, transfer, utilization, storage, maintenance, and updates. The recommended practice recommends a list of critical factors that impact the quality of data sets, such as but not limited to, data sources, data quality, annotation, privacy protection, personnel qualification/training/ evaluation, tools, equipment, environment, process control, and documentation.