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Blood Cell Damage

(Oxygenator)

Oxygenators are vital components in cardiopulmonary bypass and extracorporeal life support systems, responsible for maintaining gas exchange while preserving blood integrity. One of the most critical safety concerns is blood cell damage — including hemolysis and platelet activation — which can compromise patient outcomes during prolonged support. Evaluation of blood compatibility is therefore essential to validate device performance and meet regulatory requirements.

At our laboratory, we conduct Blood Cell Damage testing in full compliance with ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators, ensuring every device is assessed under clinically relevant conditions.

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  • Hemolysis Assessment:
    Quantification of red blood cell destruction under standardized flow and pressure conditions.

 

  • Evaluation of free plasma hemoglobin:
    Optical measurement of blood plasma to quantify the blood cell damage.

 

  • Simulated Clinical Use:
    Testing under physiologically relevant operating ranges to replicate surgical and ECMO environments.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 7199 and FDA guidance to support submissions and global approvals.
  • Patient Safety:
    Minimizing blood cell damage reduces risks of anemia, clot formation, and organ stress.

 

  • Performance Assurance:
    Reliable oxygenator function depends on maintaining gas exchange without compromising blood integrity.

 

  • Accelerated Market Access:
    Compliance with ISO 7199 and FDA guidance streamlines regulatory pathways and builds confidence with clinicians and stakeholders.

 

By combining advanced test systems, precision analytics, and strict adherence to international standards, we help manufacturers validate the hemocompatibility 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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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.

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