TNI CEN ISO/TR 24971
| Name: | TNI CEN ISO/TR 24971 |
| Validity: | Withdrawn |
| Number of pages: | 98 |
| Language: |
EN
|
| Paper: | 31,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
28,62€ b) Without ability to print, with ability to copy (printscreen) 31,80€ c) With ability to print and copy (printscreen) 41,34€ |
| Slovak title | Zdravotnícke pomôcky. Návod na použitie ISO 14971 (ISO/TR 24971: 2020) |
| English title | Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) |
| Release Date: | 01. 11. 2020 |
| Date of withdrawal: | 01. 03. 2022 |
| ICS: | 11.040.01 |
| Sorting character/National clasification code | 85 5006 |
| Level of incorporation: | idt ISO/TR 24971:2020, idt CEN ISO/TR 24971:2020 |
| Official Journal | 10/20 |
| Amendments | |
| Replaced by: | TNI CEN ISO/TR 24971:2022-03 (85 5006) |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | 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]. |
| Preview: | Náhľad normy (PDF) |