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Pressure Drop 

(Oxygenator)

In cardiopulmonary bypass and extracorporeal life support, oxygenators must deliver efficient gas exchange while maintaining stable blood flow. One critical performance parameter is pressure drop — the resistance the device imposes on circulating blood. Excessive pressure drop can strain the pump, destabilize perfusion, and increase risks of hemolysis or clot formation. That’s why ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators require rigorous pressure drop testing as part of device validation.

At our laboratory, we conduct Pressure Drop testing in full compliance with ISO 7199 and FDA Guidance, ensuring every oxygenator is evaluated under clinically relevant operating conditions.

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  • Hydraulic Resistance Measurement:
    Quantification of pressure drop across the oxygenator at varying blood flow rates.

 

  • Clinical Simulation:
    Testing under physiologically relevant hematocrit, viscosity, and temperature conditions.

 

  • Performance Stability:
    Assessment of pressure drop consistency during extended operation to confirm long-term reliability.

 

  • Clinical Simulation:
    Testing under physiologically relevant operating ranges to replicate surgical environments.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 7199 and FDA guidance to support FDA, CE, and global approvals.
  • Patient Safety:
    Minimizing pressure drop ensures stable circulation and reduces risks of blood damage or device failure.

 

  • Performance Assurance:
    Reliable hydraulic performance confirms oxygenators meet clinical demands under diverse operating conditions.

 

  • Design Optimization:
    Detailed data informs improvements in fiber geometry, housing design, and flow path efficiency.

 

  • Accelerated Market Access:
    Compliance with ISO 7199 and FDA guidance 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 hydraulic performance of their oxygenators. Partnering with us means confidence in compliance, innovation, and patient protection.

Workflow

How we work:

A clear, three-step workflow—ensures a reliable, data-driven progress.

Feasibility
Study

Performance
Charaterization

Full approval-
relevant studies

Your journey with ac.biomed:

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1.
Service Request

2.
Information Provision

3.
NDA

1.
Service Request
2.
Information Provision
3.
NDA
4.
Service Requirements
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4.
Service Specification

5.
Quotation

6.
Order

7.
Order Confirmation
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
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8.
Test Plan

9.
Test Plan Approval

10.
Test Execution

11.
Test Report
9.
Test Plan
10.
Test Plan Approval
11.
Test Execution
12.
Test Report

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“Outstanding service, reliable support, genuine customer closeness and open communication – this is our shared path to success.”

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