scope:

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.

Purpose

The purpose of this recommended practice is to establish rules of quality management of data sets for medical artificial intelligence and improve overall data quality.