STN EN ISO 5840-2/Zmena A1
| Name: | STN EN ISO 5840-2/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 2: Chirurgicky implantované náhrady srdcovej chlopne (ISO 5840-2: 2021/Amd 1: 2025) |
| English title | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021) |
| 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 5840-2:2021/A1:2025, idt ISO 5840-2:2021/Amd 1:2025 |
| Official Journal | 05/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. |
| Preview: | Náhľad normy (PDF) |