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Defoaming Characteristics

(Cardiotomy Reservoir)

In extracorporeal circulation systems, air management is critical to patient safety. Devices such as cardiotomy reservoirs and oxygenators must efficiently remove air bubbles from blood before reinfusion. Poor defoaming performance can lead to microemboli, reduced treatment efficiency, and serious complications. That’s why ISO 15674 requires rigorous evaluation of defoaming characteristics as part of device validation.

At our laboratory, we conduct Defoaming Characteristics testing in full compliance with ISO 15674, ensuring every device is assessed under clinically relevant conditions to meet international standards.

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  • Bubble Removal Efficiency:
    Quantification of air elimination performance under standardized extracorporeal flow conditions.

 

  • Foam Dissipation Analysis:
    Measurement of defoaming speed and stability to confirm safe reinfusion.

 

  • Clinical Simulation:
    Testing under physiologically relevant operating ranges to replicate surgical and ECMO environments.

 

  • Performance Stability:
    Long-term evaluation of defoaming consistency during extended operation.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 15674 requirements to support CE and global approvals.
  • Patient Safety:
    Effective defoaming prevents air embolism and ensures safe blood reinfusion.

 

  • Performance Assurance:
    Rigorous testing confirms devices maintain reliable air removal under diverse operating conditions.

 

  • Design Optimization:
    Detailed data informs improvements in reservoir geometry, filter design, and biomaterial selection.

 

  • Accelerated Market Access:
    Compliance with ISO 15674 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 defoaming characteristics of their extracorporeal circulation 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.

Feasibility
Study

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Your journey with ac.biomed:

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1.
Service Request

2.
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NDA

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4.
Service Specification

5.
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6.
Order

7.
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Service Specification
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Order
8.
Order Confirmation
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8.
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9.
Test Plan Approval

10.
Test Execution

11.
Test Report
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Test Plan
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Test Plan Approval
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Test Execution
12.
Test Report

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