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prSRPS EN ISO 14708-5:2025

Implants for surgery — Part 5: Ventricular assist devices and total artificial hearts

General information

10.99     Sep 20, 2025

ISS

Z076

European Norm

English  

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.

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 14708-5:2022

NOW

PROJECT
prSRPS EN ISO 14708-5:2025
10.99 New project approved
Sep 20, 2025

Related project

Adopted from prEN ISO 14708-5 rev IDENTICAL

Adopted from ISO/AWI 26302 IDENTICAL