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Filter Flow Rate

(Arterial Filters)

Arterial blood line filters are critical safety components in extracorporeal circulation systems, designed to protect patients by removing microemboli, air bubbles, and particulate matter before blood is reinfused. To perform this role effectively, filters must maintain a stable and sufficient flow rate under clinical operating conditions. Inadequate flow can compromise treatment efficiency, while excessive resistance may strain the extracorporeal circuit. That’s why ISO 15675 requires rigorous filter flow rate testing as part of device validation.

At our laboratory, we conduct Filter Flow Rate 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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  • Flow Capacity Measurement:
    Determination of maximum and minimum flow rates under standardized extracorporeal circulation conditions.

 

  • Hydraulic Resistance Evaluation:
    Assessment of pressure drop across the filter to confirm efficient blood passage.

 

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

 

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

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 15675 requirements to support CE and global approvals.
  • Patient Safety:
    Reliable flow rates ensure safe and effective blood filtration without compromising 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 flow rate performance of their arterial blood line filters. 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.
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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