Codes & Standards - Purchase
ISO 14708-4:2022
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
SKU: iso_073537_175986
Published by ISO
Publication Year 2022
2 Edition
58 pages
Product Details
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.
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.