Označení normy: | ČSN EN ISO 14708-4 |
Třídící znak: | 853010 |
Počet stran: | 76 |
Vydáno: | 01.01.2023 |
Harmonizace: | Norma není harmonizována |
Katalogové číslo: | 515974 |
Popis
ČSN EN ISO 14708-4
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.