Contact us

Request
Information

+49 (0)241 - 942618-0

acb-info @mds.eurofinseu.com

Dynamic Failure Mode

(Heart Valve)

Artificial heart valves operate under relentless mechanical and physiological stresses, opening and closing millions of times throughout a patient’s life. To ensure long-term reliability, manufacturers must evaluate how valves behave under dynamic loading conditions — identifying potential points of weakness before they reach the clinic. This is where dynamic failure mode testing becomes essential.

At our laboratory, we perform dynamic failure mode testing in full compliance with ISO 5840, the international standard governing heart valve prostheses. This rigorous evaluation simulates real-world operating conditions to uncover mechanical vulnerabilities and validate device durability.

closed
  • Failure Mode Identification:
    Analysis of leaflet wear, hinge fatigue, and structural degradation under accelerated cyclic loading.

 

  • Performance Monitoring:
    Evaluation of hydrodynamic function, including regurgitation, pressure gradients, and effective orifice area at specified gateways during stress testing.

 

  • Microscopic Inspection:
    Detailed reporting on mechanical or material failures to guide design improvements.

 

  • Regulatory Documentation:
    Comprehensive data packages aligned with ISO 5840 requirements to support FDA, CE, and global approvals.
  • Patient Safety:
    Detecting and mitigating potential failure modes ensures valves perform reliably over years of use.

 

  • Design Optimization:
    Insights from dynamic testing inform improvements in geometry, materials, and manufacturing processes.

 

  • Accelerated Market Access:
    ISO 5840 compliance streamlines regulatory pathways and strengthens confidence with clinicians and stakeholders.

 

By combining advanced test systems, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the resilience and reliability 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:

closed

1.
Service Request

2.
Information Provision

3.
NDA

1.
Service Request
2.
Information Provision
3.
NDA
4.
Service Requirements
closed

4.
Service Specification

5.
Quotation

6.
Order

7.
Order Confirmation
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
closed

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
Download
Certificate
ISO 9001:2015
Download

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.

Request Information