本文件为根据ISO 14971:2019开发、实施和维护医疗器械风险管理体系提供了指导。 风险管理流程可以是质量管理体系的一部分，例如基于ISO 13485:2016[24]的质量管理体系，但ISO 14971:2019不要求这样做。ISO 13485:2016中的一些要求（关于产品实现的第7条和关于监控和测量期间反馈的第8.2.1条）与风险管理相关，可以通过应用ISO 14971:2019来满足。另请参见ISO手册:ISO 13485:2016-医疗器械-实用指南[25]。

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016^[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide^[25].