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Blood Cell Damage

(Arterial Filters)

Arterial blood line filters are essential safety components in extracorporeal circulation systems, designed to remove microemboli, air bubbles, and particulate matter before blood is returned to the patient. While their protective function is critical, these filters must also preserve the integrity of circulating blood. Excessive blood cell damage — including hemolysis, platelet activation, or leukocyte depletion — can compromise patient outcomes, reduce treatment efficiency, and increase clinical risks. That’s why ISO 15675 requires rigorous evaluation of blood compatibility as part of arterial filter validation.

At our laboratory, we conduct Blood Cell Damage testing of arterial blood line filters in full compliance with ISO 15675, 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 cardiopulmonary bypass and ECMO environments.

 

  • Performance Stability:
    Long-term evaluation of blood cell integrity during extended extracorporeal circulation.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 15675 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 filter function ensures safe removal of embolic material without compromising blood quality.

 

  • Design Optimization:
    Detailed data informs improvements in filter media, housing geometry, and biomaterial selection.

 

  • Accelerated Market Access:
    Compliance with ISO 15675 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 arterial blood line filters. 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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