STN EN ISO 5840-3
| Označenie: | STN EN ISO 5840-3 |
| Platnosť: | Platná |
| Počet strán: | 68 |
| 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 3: Náhrady srdcovej chlopne implantované minimálne invazívnymi technikami (ISO 5840-3: 2021) |
| Anglický názov: | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021) |
| Dátum vydania: | 01. 08. 2021 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 2922 |
| Úroveň zapracovania: | idt EN ISO 5840-3:2021, idt ISO 5840-3:2021 |
| Vestník: | 07/21 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 5840-3:2013-07 (85 2926) |
| Poznámka vo Vestníku: | |
| Predmet normy: | 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. |
| Náhľad normy: | Náhľad normy (PDF) |