本推荐规程确定了为医疗设备中用于人工智能的数据集建立质量管理系统的最佳实践。它涵盖了数据集管理的整个周期，包括但不限于数据收集、传输、利用、存储、维护和更新。推荐做法建议了一系列影响数据集质量的关键因素，例如但不限于数据源、数据质量、注释、隐私保护、人员资格/培训/评估、工具、设备、环境、过程控制和文档。

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.