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Permeability Testing

(Vascular Prostheses)

Vascular prostheses — synthetic grafts designed to replace or bypass diseased blood vessels — must provide reliable long-term performance while maintaining blood integrity. One of the most critical safety parameters is permeability, the controlled passage of fluid through the graft wall. Excessive permeability can lead to blood leakage, while insufficient permeability may impair tissue integration. That’s why ISO 7198 requires rigorous permeability testing as part of vascular prosthesis validation.

At our laboratory, we perform Permeability Testing in full compliance with ISO 7198, ensuring every device is evaluated under clinically relevant conditions to meet international standards

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  • Fluid Leakage Measurement:
    Quantification of graft wall permeability under standardized pressure and flow conditions.

 

  • Clinical Simulation:
    Testing across physiologically relevant ranges to replicate in vivo implantation environments.

 

  • Performance Stability:
    Long-term evaluation of permeability consistency during extended exposure to blood and fluids.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 7198 requirements to support CE and global approvals.
  • Patient Safety:
    Controlled permeability prevents blood leakage while supporting tissue healing and integration.

 

  • Performance Assurance:
    Rigorous testing confirms vascular prostheses maintain stable hydraulic properties throughout their intended lifespan.

 

  • Design Optimization:
    Data-driven insights guide improvements in graft materials, coatings, and wall structure.

 

  • Accelerated Market Access:
    Compliance with ISO 7198 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 permeability of their vascular prostheses. 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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