人工智能赋能医疗设备 数据管理

[中文适用范围]： IEC PAS 63621:2025 为用于训练、测试或验证作为医疗器械组成部分的人工智能模型之数据的全生命周期管理过程提供了框架。在数据采集与管理生命周期方面，需考虑以下因素（包括但不限于）：数据的适用性、数据质量与完整性保障、数据隐私与安全、数据治理与文档记录、数据采样与偏差缓解、数据版本控制与可追溯性、数据存储与基础设施、数据访问与共享、以及数据标注与注释。本文件概述了数据生命周期的要求，涵盖从规划与采集到使用直至退役的各个阶段，并强调维持数据质量，包括数据集分类、数据注释、可追溯性、元数据全面性、代表性和有效期限等方面。 本标准的适用范围仅限于跨医学专科和各类医疗器械的高层级过程概念，不包括可由特定模态或特定设备标准文件涵盖的具体要求。本文件同时规定了数据管理质量管理体系的附加要求，组织据此证明其有能力按照适用的医疗器械指南和标准管理数据。组织可参与人工智能医疗器械生命周期中的一个或多个阶段，包括设计开发、生产、存储与分发、安装，或运行维护等。本文件亦适用于向此类组织提供数据（包括与质量管理体系相关服务）的供应商或外部合作方。 [外文原描述]： IEC PAS 63621:2025 provides a framework for the data life cycle processes for management of data used to train, test or validate an AI model that is part of a medical device. For data acquisition and management lifecycle the following considerations apply, amongst others: data suitability, data quality and integrity insurance, data privacy and security, data governance and documentation, data sampling and bias mitigation, data versioning and traceability, data storage and infrastructure, data access and sharing, and data labelling and annotation. This document outlines the requirements for the data lifecycle, covering stages from planning and acquisition to usage and decommissioning. It emphasizes maintaining data quality, including aspects such as dataset classification, data annotations, traceability, metadata comprehensiveness, representativeness, and validity periods. The scope is limited to the high-level process concepts applicable across medical specialties and device types and does not include specific requirements that can be covered by modality- or device-specific standards documents. This document outlines the additional requirements for a quality management system for data management, where an organization demonstrates its capability to manage data in accordance with applicable medical device guidance and standards. Organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing and maintenance of a medical device that incorporates AI. This document can also be used by suppliers or external parties that provide data, including quality management system-related services to such organizations.