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Heat Exchanger Performance

(Oxygenator)

In cardiopulmonary bypass and extracorporeal life support, oxygenators must do more than provide efficient gas exchange — they must also regulate blood temperature safely and effectively. The heat exchanger component ensures precise thermal control, protecting patients from hypothermia or overheating during critical procedures. That’s why Heat Exchanger Performance testing is a key requirement in device validation.

At our laboratory, we conduct Heat Exchanger Performance testing in full compliance with ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators, ensuring every device is rigorously evaluated under clinically relevant conditions.

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  • Thermal Transfer Efficiency:
    Measurement of heat exchange rates across a range of blood flow and water flow conditions.

 

  • Temperature Stability:
    Assessment of the device’s ability to maintain consistent blood temperature during extended operation.

 

  • Pressure Drop Evaluation:
    Analysis of hydraulic resistance within the heat exchanger to confirm stable circulation.

 

  • 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:
    Reliable thermal regulation prevents complications such as hypothermia, arrhythmia, or tissue damage.

 

  • Performance Assurance:
    Rigorous testing confirms oxygenators deliver both gas exchange and thermal control without compromise.

 

  • Design Optimization:
    Detailed data informs improvements in heat exchanger materials, geometry, and integration.

 

  • 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 heat exchanger 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

Our strengths

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

Quality

ac.biomed provides
quality services.

Certificate
ISO 17025
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Certificate
ISO 9001:2015
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