UNE-CEN ISO/TR 24971:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) (Endorsed by Asociación Española de Normalización in September of 2020.)
Hardcopy , PDF
English
01-09-2020
23-04-2025
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 |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
97
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| S.R. CEN ISO/TR 24971:2020 | Equivalent |
| PD CEN ISO/TR 24971:2020 | Equivalent |
| CEN ISO/TR 24971:2020 | Identical |
| ISO/TR 24971:2020 | Identical |
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