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Air Handling Capability

(Arterial Filters)

Arterial blood line filters are indispensable safety components in extracorporeal circulation systems, designed to protect patients by removing air bubbles and microemboli before blood is reinfused. Effective air handling is critical: even small amounts of residual air can lead to embolic events and severe complications. To ensure reliability, ISO 15675 requires rigorous air handling capability testing as part of arterial filter validation.

At our laboratory, we conduct Air Handling Capability testing in full compliance with ISO 15675, ensuring every arterial blood line filter 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 Characteristics:
    Evaluation of filter media and design to confirm safe reinfusion without residual bubbles.

 

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

 

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

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 15675 requirements to support CE and global approvals.
  • Patient Safety:
    Effective air handling prevents embolism and ensures safe extracorporeal circulation.

 

  • Performance Assurance:
    Rigorous testing confirms filters maintain reliable air removal under diverse clinical conditions.

 

  • Design Optimization:
    Data-driven insights guide improvements in filter geometry, defoaming systems, and biomaterial selection.

 

  • Accelerated Market Access:
    Compliance with ISO 15675 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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