ISO/DIS 18969:2025
Current
Current
The latest, up-to-date edition.
Clinical evaluation of medical devices
Available format(s)
Hardcopy , PDF
Language(s)
English - French
Published date
01-01-2025
€196.00
Excluding VAT
This document specifies, principles and a process for the clinical evaluation of medical devices.
| Committee |
ISO/TC 194
|
| DocumentType |
Draft
|
| Pages |
42
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| ISO/IEC Guide 63:2019 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 20417:2021 | Medical devices — Information to be supplied by the manufacturer |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| ISO/TR 20416:2020 | Medical devices — Post-market surveillance for manufacturers |
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