STN EN ISO 14708-2
| Označenie: | STN EN ISO 14708-2 |
| Platnosť: | Platná |
| Počet strán: | 84 |
| Jazyk: |
EN
|
| Listinná verzia: | 28,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
25,92€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 28,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 37,44€ |
| Slovenský názov: | Chirurgické implantáty. Aktívne implantovateľné zdravotnícke pomôcky. Časť 2: Kardiostimulátory (ISO 14708-2: 2019) |
| Anglický názov: | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019) |
| Dátum vydania: | 01. 10. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 3001 |
| Úroveň zapracovania: | idt EN ISO 14708-2:2022, idt ISO 14708-2:2019 |
| Vestník: | 09/22 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). |
| Náhľad normy: | Náhľad normy (PDF) |