ISO 14708-5:2020

Overview

ISO 14708-5:2020 - "Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices" - specifies safety and performance requirements for active implantable circulatory support devices. The standard applies to devices such as ventricular assist devices (VAD) (left or right), total artificial hearts (TAH), biventricular assist devices (biVAD), percutaneous assist devices, and paediatric assist devices. It covers type tests, in vitro and in vivo (animal) studies, and clinical evaluation requirements. The scope also addresses non‑implantable parts and accessories when they can affect the implantable device’s safety or performance.

Key topics and technical requirements

The document organizes technical requirements across design, testing, and documentation areas. Major topics include:

• Intended clinical use and system description - clear definition of indications, system configuration and operating limits.
• Risk management and human factors - hazard analysis, failure modes, usability and misconnection prevention.
• Design analysis and in vitro evaluation - system characterization, subsystem/component testing, dynamic haemolysis testing and other bench tests.
• Materials qualification and biocompatibility - evaluation of materials that contact blood or tissue.
• In vivo evaluation and animal studies - study objectives, success/failure criteria, perioperative care, anticoagulation and necropsy/analysis of explants.
• Clinical evaluation and reliability - collection and analysis of clinical data to demonstrate performance and safety.
• Electromagnetic compatibility (EMC) and wireless coexistence - protection from EMI, RF wireless interactions and magnetic fields.
• Environmental, mechanical and electrical protection - temperature, pressure, electrostatic discharge, defibrillator protection and other external effects.
• Packaging, markings and accompanying documentation - requirements for sterile packs, sales packaging, labelling and instructions for use.

Notably, the standard specifies type tests intended to assess device behavior on sample units rather than routine production testing.

Practical applications and users

ISO 14708-5:2020 is essential for:

• Medical device manufacturers designing and developing circulatory support systems (VAD, TAH, biVAD, percutaneous and paediatric devices).
• Regulatory affairs and quality assurance teams preparing technical files, risk management dossiers and clinical evaluation reports.
• Test laboratories and preclinical researchers conducting in vitro bench testing, haemolysis studies and in vivo animal evaluations.
• Notified bodies / regulatory reviewers assessing conformity for market approval.
• Clinicians and hospital procurement referencing device safety, performance limits and instructions for use.

Related standards

• ISO 14708 series (other parts covering different active implantable medical devices)
• ISO/TR 14283 (referenced relationship in Annex A of ISO 14708-5)

Keywords: ISO 14708-5:2020, active implantable medical devices, circulatory support devices, VAD, TAH, biVAD, percutaneous assist devices, paediatric assist devices, medical device standards, safety and performance, type tests, biocompatibility, EMC, risk management.