60.60 Standard published Jul 27, 2022
CEN/CENELEC
CEN/CLC/JTC 16 CEN/CENELEC Joint Technical Committee on Active Implantable Medical Devices
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
Published
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.
PUBLISHED
EN ISO 14708-4:2022
60.60
Standard published
Jul 27, 2022
