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+49 (0)241 - 942618-0

acb-info @mds.eurofinseu.com

Hydraulic Performance

(Blood Pump)

The efficiency and reliability of blood pumps depend on their hydraulic performance — the ability to deliver precise flow and pressure under varying physiological conditions. Inadequate hydraulic design can lead to unstable circulation, increased hemolysis, or thrombosis, making performance validation a critical step in device development.

At our laboratory, we conduct hydraulic performance testing in full compliance with ISO 18242, the international standard for extracorporeal blood pumps. This ensures that every device is precisely evaluated against globally recognized benchmarks.

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  • Flow and Pressure Characterization:
    Measurement of pump output across clinically relevant operating ranges.

 

  • Operational Stability:
    Assessment of performance under variable preload and afterload conditions, simulating patient-specific scenarios.

 

  • Compliance Documentation:
    Comprehensive reporting aligned with ISO 18242 requirements to support regulatory submissions worldwide.
  • Patient Safety:
    Reliable hydraulic performance ensures consistent perfusion.

 

  • Design Optimization:
    Data-driven insights guide improvements in impeller geometry, housing design, and control systems.

 

  • Regulatory Confidence: ISO 18242 compliance accelerates approval processes and strengthens trust with clinicians and stakeholders.

 

By combining advanced instrumentation, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the hydraulic performance of their blood pumps. 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.

Certificate
ISO 17025
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Certificate
ISO 9001:2015
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Move forward
with ac.biomed

We want to hear from you. Whether you‘re a prospective client, a professional interested in joining our team, or simply someone interested in our work, send us a note.

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