TNI CEN ISO/TR 20416
| Name: | TNI CEN ISO/TR 20416 |
| Validity: | Withdrawn |
| Number of pages: | 54 |
| Language: |
EN
|
| Paper: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Zdravotnícke pomôcky. Dohľad výrobcov zdravotníckych pomôcok po uvedení na trh (ISO/TR 20416: 2020) |
| English title | Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020) |
| Release Date: | 01. 11. 2020 |
| Date of withdrawal: | 01. 01. 2022 |
| ICS: | 11.040.01 |
| Sorting character/National clasification code | 85 5234 |
| Level of incorporation: | idt ISO/TR 20416:2020, idt CEN ISO/TR 20416:2020 |
| Official Journal | 10/20 |
| Amendments | |
| Replaced by: | TNI CEN ISO/TR 20416:2022-01 (85 5234) |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. |
| Preview: | Náhľad normy (PDF) |