CEN ISO/TR 24971:2020
Current
The latest, up-to-date edition.
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
22-07-2020
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].
| Committee |
CEN/CLC/JTC 3
|
| DocumentType |
Technical Report
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| ISO/TR 24971:2020 | Identical |
| S.R. CEN ISO/TR 24971:2020 | Identical |
| UNE-CEN ISO/TR 24971:2020 | Identical |
| PD ISO/TR 24971:2020 | Identical |
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