STN EN ISO 25539-2
| Označenie: | STN EN ISO 25539-2 |
| Platnosť: | Platná |
| Počet strán: | 128 |
| Jazyk: |
EN
|
| Listinná verzia: | 35,00€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
31,50€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 35,00€ c) S možnosťou tlače, prenosu textu a obrázkov: 45,50€ |
| Slovenský názov: | Srdcovo-cievne implantáty. Vnútrocievne pomôcky. Časť 2: Cievne stenty (ISO 25539-2: 2020) |
| Anglický názov: | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020) |
| Dátum vydania: | 01. 03. 2021 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 2925 |
| Úroveň zapracovania: | idt EN ISO 25539-2:2020, idt ISO 25539-2:2020 |
| Vestník: | 02/21 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 25539-2:2013-05 (85 2925) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary. |
| Náhľad normy: | Náhľad normy (PDF) |