Contact us

Request
Information

+49 (0)241 - 942618-0

acb-info @mds.eurofinseu.com

Water Permeability Testing

(Vascular Prostheses)

Vascular prostheses — synthetic grafts designed to replace or bypass diseased blood vessels — must demonstrate reliable hydraulic performance to ensure patient safety and long-term functionality. One of the critical parameters is water permeability, which defines the controlled passage of fluid through the graft wall. Proper permeability is essential: too high may cause blood leakage, while too low may hinder tissue integration and healing. That’s why ISO 7198 requires rigorous water permeability testing as part of vascular prosthesis validation.

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

closed
  • 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 ingrowth and healing.

 

  • 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 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

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

Looking for something specific?

Overview
Devices

Overview
Norms and Standards

Overview
Tests