Approved Work Item
ISO/AWI 26302
Ventricular assist devices and total artificial hearts
Reference number
ISO/AWI 26302
Edition 1
© ISO 2026
Approved Work Item
Under development
A working group has prepared a draft.
Will replace ISO 14708-5:2020

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.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 150/SC 2
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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