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
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