Artificial heart valves must deliver consistent, unobstructed blood flow to sustain life. One key evaluations in valve development is steady forward flow testing, which measures how effectively a valve maintains forward flow under controlled, non-pulsatile conditions. This testing provides essential data on valve efficiency, pressure gradients, and effective orifice area — all key indicators of clinical performance.
At our laboratory, we perform steady forward flow testing in full compliance with ISO 5840, the international standard for heart valve prostheses. By adhering to this rigorous framework, we ensure every valve is validated against globally recognized benchmarks for safety and reliability.
- Flow & Pressure Characterization:
Measurement of transvalvular pressure drop and effective orifice area under steady flow. - Hydrodynamic Efficiency:
Evaluation of valve performance across clinically relevant flow rates. - Design Validation:
Identification of flow limitations or inefficiencies to guide improvements in leaflet geometry and hinge design. - Regulatory Documentation:
Comprehensive reporting aligned with ISO 5840 requirements to support FDA, CE, and global approvals.
- Patient Safety:
Reliable forward flow ensures efficient circulation and reduces risks of heart failure or thromboembolic events. - Performance Assurance:
Steady flow data confirms valves meet hydrodynamic requirements before durability and pulsatile testing. - 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.