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Blood Cell Damage

(Cardiotomy Reservoir)

Extracorporeal circulation devices — such as oxygenators, blood pumps, and reservoirs — must not only deliver reliable performance but also preserve the integrity of circulating blood. One of the most critical safety concerns is blood cell damage, including hemolysis, platelet activation, and leukocyte depletion. Excessive damage can compromise patient outcomes, reduce treatment efficiency, and increase clinical risks. That’s why ISO 15674 requires rigorous evaluation of blood compatibility as part of device validation.

At our laboratory, we conduct Blood Cell Damage testing in full compliance with ISO 15674, ensuring every device is assessed under clinically relevant conditions to meet international standards.

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

 

  • Platelet & Leukocyte Evaluation:
    Measurement of activation, aggregation, and depletion to assess thrombogenic potential.

 

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

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 15674 requirements to support CE and global approvals.
  • Patient Safety:
    Minimizing blood cell damage reduces risks of anemia, clot formation, and immune complications.

 

  • Performance Assurance:
    Reliable device function ensures consistent extracorporeal support without compromising blood quality.

 

  • Design Optimization:
    Detailed data informs improvements in biomaterials, coatings, and flow path geometry

 

  • Accelerated Market Access:
    Compliance with ISO 15674 streamlines regulatory pathways and builds confidence with clinicians and stakeholders.

 

By combining advanced test systems, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the hemocompatibility of their extracorporeal circulation devices. 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.

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ISO 9001:2015
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