EN ISO 14708-4:2022

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

General information

60.60 Standard published   Jul 27, 2022

CEN/CENELEC

CEN/CLC/JTC 16

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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.

Life cycle

NOW

PUBLISHED
EN ISO 14708-4:2022
60.60 Standard published
Jul 27, 2022