Artificial heart valves must withstand millions of cycles of opening and closing under pulsatile blood flow. Over time, mechanical fatigue, material degradation, and performance drift can compromise safety and reliability. That’s why accelerated wear testing (AWT) is a critical requirement in valve validation — ensuring devices deliver consistent performance throughout their intended lifespan.
At our laboratory, we conduct accelerated wear testing in full compliance with ISO 5840, the international standard for heart valve prostheses. This rigorous framework ensures every valve is evaluated under clinically relevant conditions, simulating years of operation in a condensed timeframe.
- High-Cycle Fatigue Simulation:
Millions of opening/closing cycles performed under physiological pressures and flow rates. - Durability Assessment:
Identification of wear patterns, material fatigue, and structural integrity over extended use. - Hydrodynamic Monitoring:
Evaluation of valve function, including regurgitation, pressure gradients, and effective orifice area at specified gateway-intervals. - Regulatory Documentation:
Comprehensive reporting aligned with ISO 5840 requirements to support FDA, CE, and global submissions.
- Patient Safety:
Long-term durability ensures valves maintain reliable function without unexpected failure. - Design Optimization:
Wear data informs improvements in leaflet geometry, hinge mechanisms, and material selection. - Accelerated Market Access:
ISO 5840 compliance streamlines regulatory approval and builds confidence with clinicians and stakeholders.
By combining advanced test rigs, precision analytics, and strict adherence to ISO standards, we help manufacturers validate the durability and reliability of their artificial heart valves. Partnering with us means confidence in compliance, innovation, and patient protection.