BS EN ISO 14708-4:2022 - Page 2

Implants for surgery. Active implantable medical devices.. Implantable infusion pump systems | Status: Current

1 Scope 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.