Dimensional Attributes

A contactless optical gauging machine is used to measure dimensional attributes of the device.

Test Procedure

A contactless optical gauging machine  is used to measure dimensional attributes of stent and related devices; undeployed and at several deployment diameters.

This may include measurements such as:

Functional Length: Measure the maximum length of device that will effectively be inserted in the body.

Nominal Diameter: The length of the device tip is measured using a calibrated optical system with 5 micrometers accuracy that does not require contact.

 

Equipment

Optical gauging machine

Measured Parameters

  • Deployed Diameter
  • System Compliance
  • Uniformity of Expansion
  • Stent Length
  • Crossing Profile
  • Strut and Bridge Thickness
  • Percent Solid Area
  • Delivery System Dimensions

Scope

Any device requiring physical measurements or dimensional attributes.

Service Levels

Applicable Standards

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

Related Tests

OLE1209

Dimensional analysis of interventional medical devices and cardiovascular implants

Interventional device inspection


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.

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Free Initial Consultations
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