ISO 14708-4:2022

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
Autor: ISO
Código ICS: 11.040.40
Vigente
$234.430

Alcance

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.

Especificaciones de la Norma
Fecha de Publicación 28/02/2022
Título Secundario Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 4: Systèmes de pompe à perfusion implantables
Páginas Técnicas 58
Idioma Inglés