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Water Entry Pressure Testing

(Vascular Prostheses)

Vascular prostheses — synthetic grafts designed to replace or bypass diseased blood vessels — must demonstrate reliable performance under physiological conditions.

One of the critical safety parameters is water entry pressure, which defines the minimum pressure required for fluid to penetrate the graft wall. This property is essential to ensure that the prosthesis prevents leakage during implantation while still supporting tissue integration. That’s why ISO 7198 requires rigorous water entry pressure testing as part of vascular prosthesis validation.

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

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  • Pressure Threshold Measurement:
    Determination of the minimum pressure at which fluid penetrates the graft wall.

 

  • Leakage Resistance Evaluation:
    Verification that the prosthesis maintains integrity under physiologically relevant pressures.

 

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

 

  • Performance Stability:
    Long-term evaluation of water entry pressure consistency during extended exposure to fluids.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 7198 requirements to support CE and global approvals.
  • Patient Safety:
    Reliable water entry pressure prevents blood leakage during implantation and early use.

 

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

 

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

 

  • 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 entry pressure performance 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

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“Outstanding service, reliable support, genuine customer closeness and open communication – this is our shared path to success.”

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