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Steady Backflow Leakage

(Heart Valve)

Artificial heart valves must not only enable efficient forward blood flow but also prevent excessive leakage in the reverse direction. Steady backward leakage testing is a critical evaluation that measures regurgitant flow under controlled, non-pulsatile conditions. This ensures valves maintain proper closure and minimize risks of inefficiency, clot formation, or patient complications.

At our laboratory, we perform steady backward leakage testing in full compliance with ISO 5840, the international standard for heart valve prostheses. This rigorous assessment validates valve sealing performance and provides essential data for regulatory approval and design optimization.

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  • Leakage Quantification:
    Measurement of regurgitant volumes under steady-state conditions across clinically relevant pressure ranges.

 

  • Seal Integrity Assessment:
    Evaluation of leaflet closure and hinge design to ensure reliable valve function.

 

  • Design Optimization:
    Identification of leakage pathways to guide improvements in geometry, materials, and manufacturing processes.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 5840 requirements to support FDA, CE, and global submissions.
  • Patient Safety:
    Minimizing backward leakage reduces risks of heart failure, thromboembolic events, and device inefficiency.

 

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

 

  • 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 sealing 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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