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Blood Cell Damage

(Cannula)

Implanted blood access devices are essential for patients requiring long-term hemodialysis, providing reliable vascular access while maintaining blood integrity. One of the most critical safety concerns is blood cell damage — including hemolysis, platelet activation, and leukocyte depletion — which can compromise treatment effectiveness and patient outcomes. That’s why ISO 18193 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 18193, 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 hemodialysis 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 dialysis treatment environments.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 18193 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 dialysis treatment without compromising blood quality.

 

  • Design Optimization:
    Detailed data informs improvements in lumen geometry, surface coatings, and biomaterial selection.

 

  • Accelerated Market Access:
    Compliance with ISO 18193 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 implanted blood access 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

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

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