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Integral Water Permeability Testing

(Vascular Prostheses)

Vascular prostheses — synthetic grafts designed to replace or bypass diseased blood vessels — must demonstrate not only mechanical strength and durability but also controlled integral water permeability. This property defines how much fluid can pass through the graft wall under pressure. Excessive permeability can lead to blood leakage, while insufficient permeability may impair tissue healing and integration. That’s why ISO 7198 requires rigorous integral water permeability testing as part of vascular prosthesis validation

At our laboratory, we perform Integral Water 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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  • Leakage Quantification:
    Measurement of water permeability across the graft wall under standardized pressure conditions.

 

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

 

  • Performance Stability:
    Long-term evaluation of permeability consistency during extended exposure to 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 integral water 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

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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

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