EN ISO 14971:2019+A11:2021
Current
Current
The latest, up-to-date edition.
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Published date
08-12-2021
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This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
| Committee |
JTC 3
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 14971:2019/A11:2021 | Identical |
| ISO 14971:2019 | Identical |
| CEI UNI EN ISO 14971/A11:2022 | Identical |
| PN-EN ISO 14971:2020-05/A11:2022-05 | Identical |
| BS EN ISO 14971:2019+A11:2021 | Equivalent |
| ÖVE/ÖNORM EN ISO 14971:2022 05 15 | Identical |
| BS EN ISO 14971:2019+A11:2021 | Identical |
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