STN EN ISO 14708-4
| Označenie: | STN EN ISO 14708-4 |
| Platnosť: | Platná |
| Počet strán: | 72 |
| 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 4: Systémy implantovateľných infúznych púmp (ISO 14708-4: 2022) |
| Anglický názov: | Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022) |
| Dátum vydania: | 01. 10. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 3001 |
| Úroveň zapracovania: | idt ISO 14708-4:2022, idt EN ISO 14708-4:2022 |
| Vestník: | 09/22 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. NOTE This document is not intended to apply to non-implantable infusion systems. |
| Náhľad normy: | Náhľad normy (PDF) |