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Recirculation Testing 

(Cannula)

Implanted blood access devices are essential for patients undergoing long-term hemodialysis, providing reliable vascular access for repeated treatments. One of the most critical performance parameters is recirculation — the unintended mixing of dialyzed blood with undialyzed blood. Excessive recirculation reduces dialysis efficiency, compromises treatment outcomes, and increases patient risk. That’s why ISO 18193 requires rigorous recirculation testing as part of device validation.

At our laboratory, we perform Recirculation Testing in full compliance with ISO 18193, ensuring every device is evaluated under clinically relevant conditions to meet international standards.

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  • Quantitative Measurement:
    Determination of recirculation rates under standardized hemodialysis flow and pressure conditions.

 

  • Clinical Simulation:
    Testing across physiologically relevant operating ranges to replicate dialysis treatment environments.

 

  • Design Validation:
    Identification of flow inefficiencies related to lumen geometry, connector design, or cannulation technique.

 

  • Regulatory Documentation: Comprehensive reporting aligned with ISO 18193 requirements to support CE and global approvals.
  • Patient Safety:
    Minimizing recirculation ensures effective dialysis and reduces risks of inadequate toxin removal.

 

  • Performance Assurance:
    Reliable device function guarantees consistent treatment efficiency across repeated sessions.

 

  • Design Optimization:
    Data-driven insights guide improvements in device geometry, materials, and manufacturing processes.

 

  • 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 recirculation performance 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

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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