ANSI/AAMI/ ISO 14971:2019
Current
The latest, up-to-date edition.
Medical devices—Application of risk management to medical devices
English
10-05-2019
This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-718-1
|
| Pages |
49
|
| ProductNote |
This standard also refers to :-IEC/TR 60513
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 14971:2019 | Identical |
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