STN EN ISO 5840-1/Zmena A1
| Name: | STN EN ISO 5840-1/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 16 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Srdcovo-cievne implantáty. Protézy srdcovej chlopne. Časť 1: Všeobecné požiadavky (ISO 5840-1: 2021/Amd 1: 2025) |
| English title | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021) |
| 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 5840-1:2021/A1:2025, idt ISO 5840-1:2021/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 and provides general requirements. Subsequent parts of the ISO 5840 series provide specific equirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are 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) |