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Blood Path Integrity Testing

(Cannula)

Implanted blood access devices are the foundation of long-term hemodialysis treatment, providing reliable vascular access for repeated procedures. To ensure patient safety and device reliability, these devices must demonstrate blood path integrity — the ability to maintain a secure, unobstructed, and leak-free passage for blood flow throughout their intended lifespan. Any compromise in blood path integrity can lead to leakage, contamination, or treatment inefficiency. That’s why ISO 18193 requires rigorous blood path integrity testing as part of device validation.

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

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  • Leakage Resistance:
    Verification that the blood path remains sealed under physiologically relevant pressures and flow rates.

 

  • Structural Integrity:
    Assessment of lumen geometry, wall strength, and connector performance to confirm durability.

 

  • Functional Reliability:
    Testing of ports, junctions, and access points to ensure consistent blood flow without obstruction.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 18193 requirements to support CE and global approvals.
  • Patient Safety:
    Reliable blood path integrity prevents leakage, infection risk, and treatment interruption.

 

  • Performance Assurance:
    Testing confirms devices maintain secure and consistent blood flow during repeated dialysis sessions.

 

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

 

  • Accelerated Market Access:
    Compliance with ISO 18193 streamlines regulatory pathways and builds confidence with clinicians and stakeholders.

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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