prEN ISO 14708-5 rev

Implants for surgery — Part 5: Ventricular assist devices and total artificial hearts prEN ISO 14708-5 rev

Scope

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.