PD CEN ISO/TR 24971:2020 - TC

This standard PD CEN ISO/TR 24971:2020 - TC Tracked Changes. Medical devices. Guidance on the application of ISO 14971 is classified in these ICS categories:

• 11.040.01 Medical equipment in general

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]}.