医疗器械 医疗器械风险管理的应用

[中文适用范围]： 本文件规定了医疗器械风险管理的术语、原则和流程，包括医疗器械软件和体外诊断医疗器械。 本文件中描述的流程旨在帮助医疗器械制造商识别与医疗器械相关的危害，估计和评估相关风险，控制这些风险，并监控控制措施的有效性。 本文件的要求适用于医疗器械生命周期的所有阶段。 本文件中描述的流程适用于与医疗设备相关的风险，例如与生物相容性、数据和系统安全、电力、移动部件、辐射和可用性相关的风险。 本文档中描述的流程也适用于在某些司法管辖区不一定是医疗器械的产品，也可供医疗器械生命周期中涉及的其他人使用。 本文件不适用于： ——在任何特定临床程序中使用医疗器械的决定；或者——业务风险管理。 该文件要求制造商建立风险可接受性的客观标准，但没有指定可接受的风险水平。 风险管理可以成为质量管理体系的一个组成部分。 然而，该文件并不要求制造商拥有适当的质量管理体系。 注：本文件的应用指南可参见 ISO/TR 24971[9]。 [外文原描述]： ISO 14971:2019 is the international standard that specifies terminology, principles, and a comprehensive process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The standard establishes a systematic framework for identifying hazards associated with medical devices, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls throughout the entire device life cycle. The 2019 edition (third edition) represents a significant evolution from previous versions, with enhanced focus on benefit-risk analysis, expanded requirements for production and post-production activities, and stronger alignment with regulatory requirements in major markets worldwide. The standard requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels, recognizing that risk acceptability depends on the specific device context and intended use. The risk management process described in ISO 14971 applies from initial conception of a medical device through its ultimate decommissioning and disposal, covering all types of risks including those related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.