ISO 14708-4:2022

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems

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.

Edition	2022
Standard Part No	4
Published Date	2022
Published By	International Standardization Organisation
Page Count	58