标准编号：ISO/TR 24971:2020
中文名称：医疗器械 ISO 14971应用指导
英文名称：Medical devices — Guidance on the application of ISO 14971
发布日期：2020-06
标准范围
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 , 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 .
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