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Air Handling Capacity

(Cardiotomy Reservoir)

In extracorporeal circulation systems, devices such as oxygenators and reservoirs must not only deliver efficient gas exchange and blood handling but also ensure safe and effective air management. The ability to remove and handle air bubbles is critical to patient safety, as residual air can lead to embolism and severe complications. That’s why ISO 15674 requires rigorous Air Handling Capacity testing as part of device validation.

At our laboratory, we conduct Air Handling Capacity testing in full compliance with ISO 15674, ensuring every device is evaluated 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.

 

  • Defoaming & Filtration Assessment:
    Evaluation of defoaming systems and filter elements to confirm safe reinfusion.

 

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

 

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

 

  • Regulatory Documentation: Comprehensive reporting aligned with ISO 15674 requirements to support CE and global approvals.
  • Patient Safety:
    Effective air handling prevents 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 air handling capacity of their extracorporeal circulation 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

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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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