STN EN ISO 5840-2
| Označenie: | STN EN ISO 5840-2 |
| Platnosť: | Platná |
| Počet strán: | 64 |
| Jazyk: |
EN
|
| Listinná verzia: | 24,40€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
21,96€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 24,40€ c) S možnosťou tlače, prenosu textu a obrázkov: 31,72€ |
| Slovenský názov: | Srdcovo-cievne implantáty. Protézy srdcovej chlopne. Časť 2: Chirurgicky implantované náhrady srdcovej chlopne (ISO 5840-2: 2021) |
| Anglický názov: | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021) |
| Dátum vydania: | 01. 08. 2021 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 2922 |
| Úroveň zapracovania: | idt EN ISO 5840-2:2021, idt ISO 5840-2:2021 |
| Vestník: | 07/21 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 5840-2:2016-03 (85 2922) |
| Poznámka vo Vestníku: | |
| Predmet normy: | 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. |
| Náhľad normy: | Náhľad normy (PDF) |