Crush Resistance – Pressure Control

The goal of the test is to determine the load or deformation characteristics of the stent while a circumferentially uniform radial load is applied.

Test Procedure

The device is deployed in a silicon thin wall tube and a uniform pressure is applied around the tube. A precision optical microscope is used to assess the device dimensions at defined pressures. The load and the associated diameter is recorded while compressing the stent until an appreciable reduction in force occurs or a diameter reduction of at least 50 % is reached.

Equipment

Optical gauging machine
Thermoregulation system
Calibrated thermometer
Pressure measurement system
Calibrated manometer

Measured Parameters

Applied pressure
Dimensional variations
Temperature

Scope

Balloon Expandable Stents or equivalent devices

Service Levels

Applicable Standards

ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Related Tests

OLE0802

ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

Timeliness
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

Free Initial Consultations
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