Radiopacity

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 a test sample and a user-defined standard with or without the use of a body mimic.

Test Procedure

Test specimens are placed so it sits in the middle of the X-ray image area in the X-ray imaging system. X-ray images are made at specified voltages, times, and currents.  Settings are typical of those used in the X-ray diagnosis of human and are appropriate for the product and for the particular area of body interest. Radiopacity of the device is determined by qualitatively comparing image(s) of a test sample and a user-defined standard with or without the use of a body mimic.  A comparative study will be conducted using client test sample against test samples with a proven clinical track record.

Specimens are exposed to X-Ray levels necessary for the imaging system, the product or material, and the area of the body within which the product is intended for use.   Digital analysis method is used to produce the images in accordance with the equipment manufacturer’s instructions.

 

Equipment

Fluoroscopic equipment setup requires certified technician for operations.  Equipment is operated in a regulated operating room and requires testing outside hospital business hours between 17h and 19h

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)

Scope

  • Radiopacity coronary and peripheral stent
  • Radiopacity interventional devices
  • Radiopacity medical devices

Service Levels

Applicable Standards

  • ASTM F640 – 20
    Standard Test Methods for Determining Radiopacity for Medical Use

Related Tests

OLE1115


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