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Heart Valve Testing

(ISO 5840 · FDA Guidance)

Definition

Artificial Heart Valve Testing

Artificial heart valves are among the most critical life-saving implants in cardiovascular medicine. Designed to restore proper blood flow and replace damaged native valves, they must perform flawlessly under continuous mechanical and biological stress. From durability and hydraulic efficiency to hemocompatibility and thrombogenicity, every aspect of valve performance directly impacts patient safety and long-term outcomes.

At our laboratory, we provide comprehensive testing services for artificial heart valves, combining performance evaluation with state-of-the-art simulation environments. We help manufacturers validate performance characteristics ensuring every device meets the highest standards before being clinically approved.

By partnering with us, medical device innovators gain more than testing services: they gain a trusted ally in accelerating development, reducing risk, and bringing life-saving technologies to market with confidence.

Overview

The Tests

Accelerated Wear

(Heart Valve)

Air Handling Capability

(Arterial Filters)

Air Handling Capacity

(Cardiotomy Reservoir)

ASTM F 1841

(Blood Pump)

ASTM F 3067

(Stents)

Blood Cell Damage

(Cannula)

Blood Cell Damage

(Arterial Filters)

Blood Cell Damage

(Cardiotomy Reservoir)

Blood Cell Damage

(Oxygenator)

Blood Path Integrity Testing

(Cannula)

Calcification

(Heart Valve)

Cavitation

(Blood Pump)

Chronic Outward Force

(Stent)

Computational Flow Field Assessment

(Heart Valve)

Defoaming Characteristics

(Cardiotomy Reservoir)

Dynamic Failure Mode

(Heart Valve)

FDA Guidance

(Heart Valve · Oxygenator)

Filter Flow Rate

(Arterial Filters)

Filtration Efficiency

(Arterial Filters)

Gas Exchange Performance

(Oxygenator)

Heat Exchanger Performance

(Oxygenator)

Hemolysis

(Blood Pump)

Hydraulic Performance

(Blood Pump)

Hydrodynamic Performance 

(Heart Valve)

In‑Vitro Validation of Computational Models (ASME V&V 40)

(Individual)

Individual Test Setups

(Individual)

Integral Water Permeability Testing

(Vascular Prostheses)

Integrity

(Cannula)

ISO 14708-5

(Blood Pump)

ISO 15674

(Cardiotomy Reservoir)

ISO 15675

(Arterial Filters)

ISO 18193

(Cannula)

ISO 18242

(Blood Pump)

ISO 25539

(Stents)

ISO 5840

(Heart Valve)

ISO 7198

(Vascular Prostheses)

ISO 7199

(Oxygenator)

Kink Resistance Testing  

(Cannula)

Next‑Generation Mock‑Loops 

(Individual)

Particle Image Velocimetry (PIV) 

(Heart Valve)

Permeability Testing

(Vascular Prostheses)

Pressure Drop 

(Oxygenator)

Pressure Drop 

(Cannula)

Radial Resistive Force 

(Stent)

Recirculation Testing 

(Cannula)

Steady Backflow Leakage

(Heart Valve)

Steady Forward Flow

(Heart Valve)

Thrombogenicity

(Blood Pump)

Thrombogenicity

(Heart Valve)

Water Entry Pressure Testing

(Vascular Prostheses)

Water Permeability Testing

(Vascular Prostheses)