本文件采用ISO 14971:2019，其中规定了医疗设备风险管理的术语、原则和流程，包括作为医疗设备的软件和体外诊断医疗设备。本文件中描述的过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，并监测控制措施的有效性。

This document adopts ISO 14971:2019, which specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.