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immediate downloadReleased: 2020-08-14
PD CEN ISO/TR 24971:2020 - TC
Tracked Changes. Medical devices. Guidance on the application of ISO 14971
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| Standard number: | PD CEN ISO/TR 24971:2020 - TC |
| Pages: | 214 |
| Released: | 2020-08-14 |
| ISBN: | 978 0 539 14677 6 |
| Status: | Tracked Changes |
DESCRIPTION
PD CEN ISO/TR 24971:2020 - TC
This standard PD CEN ISO/TR 24971:2020 - TC Tracked Changes. Medical devices. Guidance on the application of ISO 14971 is classified in these ICS categories:
- 11.040.01 Medical equipment in general
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].