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Kink Resistance Testing  

(Cannula)

Implanted blood access devices are critical for patients undergoing long-term hemodialysis, providing reliable vascular access for repeated treatments. To ensure consistent performance, these devices must maintain unobstructed blood flow even under bending, flexing, and mechanical stress.

One of the key safety parameters is kink resistance — the ability of the device to resist collapse or occlusion when subjected to bending forces. Excessive kinking can compromise dialysis efficiency, increase recirculation, and put patients at risk. That’s why ISO 18193 requires rigorous kink resistance testing as part of device validation.

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

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  • Mechanical Flex Testing:
    Evaluation of device performance under controlled bending angles and repeated flex cycles.

 

  • Flow Integrity Assessment:
    Measurement of blood flow rates and pressure drop during simulated kinking scenarios.

 

  • Durability Analysis:
    Long-term testing to confirm kink resistance over repeated use and extended implantation.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 18193 requirements to support CE and global approvals.
  • Patient Safety:
    Reliable kink resistance ensures stable blood flow and reduces risks of treatment interruption.

 

  • Performance Assurance:
    Testing confirms devices maintain lumen patency and functional reliability under clinical stresses.

 

  • Design Optimization:
    Data-driven insights guide improvements in geometry, wall thickness, and material 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 kink resistance 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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