STN EN ISO 5840-3/Zmena A1
| Name: | STN EN ISO 5840-3/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 12 |
| Language: |
EN
|
| Paper: | 9,70€ |
| Electronic version |
a) Only read (without ability to print and copy)
8,73€ b) Without ability to print, with ability to copy (printscreen) 9,70€ c) With ability to print and copy (printscreen) 12,61€ |
| Slovak title | Srdcovo-cievne implantáty. Protézy srdcovej chlopne. Časť 3: Náhrady srdcovej chlopne implantované minimálne invazívnymi technikami (ISO 5840-3: 2021/Amd 1: 2025) |
| English title | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021) |
| Release Date: | 01. 06. 2025 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 2922 |
| Level of incorporation: | idt EN ISO 5840-3:2021/A1:2025, idt ISO 5840-3:2021/Amd 1:2025 |
| Official Journal | 05/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. |
| Preview: | Náhľad normy (PDF) |