60.60 Standard published Jul 22, 2020
CEN/CENELEC
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
Technical Report
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].
PUBLISHED
CEN ISO/TR 24971:2020
60.60
Standard published
Jul 22, 2020