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Steady Forward Flow

(Heart Valve)

Artificial heart valves must deliver consistent, unobstructed blood flow to sustain life. One key evaluations in valve development is steady forward flow testing, which measures how effectively a valve maintains forward flow under controlled, non-pulsatile conditions. This testing provides essential data on valve efficiency, pressure gradients, and effective orifice area — all key indicators of clinical performance.

At our laboratory, we perform steady forward flow testing in full compliance with ISO 5840, the international standard for heart valve prostheses. By adhering to this rigorous framework, we ensure every valve is validated against globally recognized benchmarks for safety and reliability.

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  • Flow & Pressure Characterization:
    Measurement of transvalvular pressure drop and effective orifice area under steady flow.

 

  • Hydrodynamic Efficiency:
    Evaluation of valve performance across clinically relevant flow rates.

 

  • Design Validation:
    Identification of flow limitations or inefficiencies to guide improvements in leaflet geometry and hinge design.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 5840 requirements to support FDA, CE, and global approvals.
  • Patient Safety:
    Reliable forward flow ensures efficient circulation and reduces risks of heart failure or thromboembolic events.

 

  • Performance Assurance:
    Steady flow data confirms valves meet hydrodynamic requirements before durability and pulsatile testing.

 

  • Accelerated Market Access:
    ISO 5840 compliance 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 hydrodynamic performance of their artificial heart valves. 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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