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Cannula Testing

(ISO 18193)

Definition

Cannula Testing for Cardiovascular
and Extracorporeal Devices

Cannulae are essential components in extracorporeal circulation systems, enabling safe and efficient vascular access during procedures such as cardiopulmonary bypass, ECMO, and dialysis. Their performance directly impacts patient safety, surgical outcomes, and device reliability. From flow dynamics to biocompatibility, every aspect of cannula design must be rigorously validated before clinical use.

At our laboratory, we provide comprehensive testing services for cannulae, combining performance evaluation, advanced instrumentation, and expert analysis. ensuring compliance with international standards and supporting manufacturers in delivering safe, high-performance devices to market.

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  • Hydraulic Performance:
    Measurement of flow rates, pressure drops, and resistance under clinically relevant conditions.

 

  • Structural Integrity:
    Evaluation of mechanical strength, kink resistance, and durability during extended use.

 

  • Hemocompatibility:
    Assessment of blood-material interactions to minimize hemolysis, platelet activation, and thrombogenicity.

 

  • Design Validation:
    Testing of tip geometry, side holes, and coatings to optimize insertion and flow characteristics.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO and FDA guidance to support global approvals.
  • Patient Safety:
    Reliable cannula performance ensures stable circulation and reduces risks of blood damage or device failure.

 

  • Performance Assurance:
    Rigorous testing confirms cannulae meet clinical demands across diverse operating environments.

 

  • Design Optimization:
    Detailed data informs improvements in geometry, materials, and manufacturing processes.

 

  • Accelerated Market Access:
    Compliance-driven testing streamlines regulatory pathways and builds confidence with clinicians and stakeholders.

 

By combining advanced instrumentation, expert analysis, and strict adherence to international standards, we help manufacturers validate the safety and performance of their cannulae. Partnering with us means confidence in compliance, innovation, and patient protection.

Overview

The Tests

Blood Cell Damage

(Cannula)

Blood Path Integrity Testing

(Cannula)

Integrity

(Cannula)

Kink Resistance Testing  

(Cannula)

Pressure Drop 

(Cannula)

Recirculation Testing 

(Cannula)