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Pressure Drop 

(Cannula)

Implanted blood access devices are vital for patients undergoing long-term hemodialysis, providing consistent vascular access for repeated treatments. One of the most critical performance parameters is pressure drop — the resistance the device imposes on blood flow. Excessive pressure drop can reduce dialysis efficiency, strain the vascular system, and compromise patient outcomes. That’s why ISO 18193 requires rigorous pressure drop testing as part of device validation.

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

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  • Hydraulic Resistance Measurement:
    Quantification of pressure drop across the device at varying blood flow rates.

 

  • Clinical Simulation:
    Testing under physiologically relevant hematocrit, viscosity, and temperature conditions to replicate dialysis environments.

 

  • Performance Stability:
    Assessment of pressure drop consistency during extended operation to confirm long-term reliability.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 18193 requirements to support CE and global approvals.
  • Patient Safety:
    Minimizing pressure drop ensures stable circulation and effective dialysis treatment.

 

  • Performance Assurance:
    Reliable hydraulic performance confirms devices meet clinical demands under diverse operating conditions.

 

  • Design Optimization:
    Detailed data informs improvements in lumen geometry, connector design, and material selection.

 

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

 

By combining advanced instrumentation, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the hydraulic performance of their implanted blood access devices. Partnering with us means confidence in compliance, innovation, and patient protection.

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How we work:

A clear, three-step workflow—ensures a reliable, data-driven progress.

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Study

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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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