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EVS-EN ISO 14708-4:2022

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)

General information
Valid from 16.08.2022
Base Documents
ISO 14708-4:2022; EN ISO 14708-4:2022
Directives or regulations
None
Standard history
Status
Date
Type
Name
16.08.2022
Main
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.
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