STN EN ISO 14708-5
| Označenie: | STN EN ISO 14708-5 |
| 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 5: Prístroje na podporu obehu (ISO 14708-5: 2020) |
| Anglický názov: | Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020) |
| Dátum vydania: | 01. 10. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 3001 |
| Úroveň zapracovania: | idt EN ISO 14708-5:2022, idt ISO 14708-5:2020 |
| Vestník: | 09/22 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products. Included in the scope of this document are: |
| Náhľad normy: | Náhľad normy (PDF) |