DS/EN ISO 14708-4
Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
| Organization: | DS |
| Publication Date: | 14 October 2022 |
| Status: | active |
| Page Count: | 72 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
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.
Document History
