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

Smartscope

Smartscope


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