| Publication CODE |
Title |
| ISO TR 24971:2020 (2020-06) |
MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971 |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
229.00 €
|
87. |
Description
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.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2020-06-16 |
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| IEC publication date |
2020-06-16 |
| IEC stability date |
2023-12-31 |
| IEC file modification date |
2020-06-19 |
| IEC last modification date |
2020-06-19 |
|
