Contact us

Request
Information

+49 (0)241 - 942618-0

acb-info @mds.eurofinseu.com

Gas Exchange Performance

(Oxygenator)

Oxygenators are the core of extracorporeal circulation systems, responsible for maintaining life-sustaining gas exchange during cardiopulmonary bypass and ECMO procedures. Their ability to efficiently transfer oxygen into the blood and remove carbon dioxide is critical to patient safety and surgical success. That’s why Gas Exchange Performance testing is a fundamental requirement in device validation.

At our laboratory, we conduct Gas Exchange 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.

closed
  • Oxygen Transfer Efficiency:
    Measurement of oxygen uptake across a range of blood flow rates and operating conditions.

 

  • Carbon Dioxide Removal:
    Quantification of CO₂ elimination to confirm effective respiratory support.

 

  • Physiological Simulation:
    Testing under controlled temperature, hematocrit, and gas flow conditions to replicate clinical use.

 

  • Performance Stability:
    Long-term evaluation of gas exchange consistency during extended operation.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 7199 and FDA guidance to support FDA, CE, and global approvals.
  • Patient Safety:
    Reliable gas exchange ensures vital organ support during critical procedures.

 

  • Performance Assurance:
    Rigorous testing confirms oxygenators meet clinical demands under varying operating conditions.

 

  • Design Optimization:
    Detailed data informs improvements in membrane materials, fiber geometry, and device design.

 

  • 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 gas exchange 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:

closed

1.
Service Request

2.
Information Provision

3.
NDA

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

4.
Service Specification

5.
Quotation

6.
Order

7.
Order Confirmation
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
closed

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
Download
Certificate
ISO 9001:2015
Download

Move forward
with ac.biomed

We want to hear from you. Whether you‘re a prospective client, a professional interested in joining our team, or simply someone interested in our work, send us a note.

Request Information