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Filtration Efficiency

(Arterial Filters)

Arterial blood line filters are vital safety components in extracorporeal circulation systems, designed to protect patients by removing microemboli, air bubbles, and particulate matter before blood is returned to the body. Their performance directly impacts patient safety during cardiopulmonary bypass and ECMO procedures. To ensure reliability, these filters must undergo rigorous filtration efficiency testing, as required by ISO 15675.

At our laboratory, we perform Filtration Efficiency 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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  • Microemboli Removal:
    Quantification of filter efficiency in capturing particles and bubbles under standardized extracorporeal flow conditions.

 

  • Air Handling Performance:
    Evaluation of bubble-trapping and defoaming characteristics to ensure safe reinfusion.

 

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

 

  • Performance Stability:
    Long-term evaluation of filtration efficiency during extended operation.

 

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

 

  • Performance Assurance:
    Rigorous testing confirms filters maintain efficiency under diverse clinical conditions.

 

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

 

  • Accelerated Market Access:
    Compliance with ISO 15675 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 filtration efficiency of their arterial blood line filters. 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

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.

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ISO 9001:2015
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