DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
Implants for surgery - Part 5: Ventricular assist devices and total artificial hearts
Abstract
This document specifies general non-clinical requirements and tests to demonstrate basic safety and essential performance of durable and temporary ventricular assist devices (VADs) and total artificial hearts (TAHs). Recommendations for additional design considerations and characterization testing are also provided. Left, right, and biventricular support systems and adult and paediatric usage are considered. Extracorporeal Membrane Oxygenation (ECMO) Systems, cardiopulmonary bypass, intra-aortic balloon pumps (IABP), and other balloon-based therapies are excluded from this standard.
Begin
2025-09-20
WI
JT016013
Planned document number
prEN ISO 14708-5 rev
Responsible national committee
DKE/GUK 812.5 - Aktiv betriebene Implantate
Responsible european committee
CEN/CLC/JTC 16 - Active Implantable Medical Devices
