Stent Radiopacity: Measured parameters
- X-ray images
- X-ray imaging system settings (voltages, times and currents, DSI, image cadence, source-to-detector distance, sample-to-detector distance, isocenter-to-focus distance)
Stent Radiopacity: Scope
- Radiopacity coronary and peripheral stent
- Radiopacity interventional devices
- Radiopacity medical devices
FDA GLP guidelines
Stent Radiopacity: Associated tests
- Device pre-conditioning - Simulated use on IDTE 2000
- Stent Recoil and Foreshortening
- Stent dimensional attributes
Stent Radiopacity: Test method description
Test specimens are exposed to X-Ray levels necessary for the imaging system and the product or material. Digital analysis method is used to produce the images in accordance with the equipment manufacturer’s instructions. Radiopacity of the device is determined by qualitatively comparing X-ray image(s) of test sample and a user-defined standard with or without the use of a body mimic.