本文件规定了医疗器械风险管理的术语、原则和过程，包括作为医疗器械的软件和体外诊断医疗器械。本文件中所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。本文件的要求适用于医疗器械生命周期的所有阶段。本文件中描述的过程适用于与医疗设备相关的风险，例如与生物相容性、数据和系统安全性、电力、运动部件、辐射和可用性相关的风险。本文件中所述的过程也可适用于在某些管辖区不一定是医疗器械的产品，也可用于医疗器械生命周期中涉及的其他产品。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-商业风险管理。本文件要求制造商建立风险可接受性的客观标准，但未规定可接受的风险水平。风险管理可以是质量管理体系的一个组成部分。但是，本文件不要求制造商建立质量管理体系。注:本文件的应用指南见ISO\/TR 24971[9]。

This document 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. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: — decisions on the use of a medical device in the context of any particular clinical procedure; or — business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].