Artificial heart valves must deliver precise, reliable blood flow under the demanding conditions of the cardiovascular system. Their hydrodynamic performance — the ability to regulate forward flow while minimizing regurgitation and pressure gradients — is a critical determinant of both safety and long-term clinical success.
At our laboratory, we perform hydrodynamic performance testing in full compliance with ISO 5840, the international standard governing heart valve prostheses. This ensures every device is rigorously evaluated against globally recognized benchmarks.
- Flow & Pressure Gradients:
Measurement of effective orifice area, transvalvular pressure drop, and regurgitant volumes. - Dynamic Response:
Assessment of valve opening and closing behavior under pulsatile flow conditions. - Regulatory Documentation:
Comprehensive reporting aligned with ISO 5840 requirements to support CE marking, FDA submissions, and global approvals.
- Patient Safety:
Reliable hydrodynamic performance ensures efficient circulation and reduces risks of heart failure or thromboembolic events. - Design Optimization:
Detailed flow data informs improvements in leaflet geometry, hinge mechanisms, and material selection. - Accelerated Market Access:
ISO 5840 compliance streamlines regulatory pathways and builds confidence with clinicians and stakeholders.
By combining advanced instrumentation, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the hydrodynamic performance of their artificial heart valves. Partnering with us means confidence in compliance, innovation, and patient protection.