ASTM F640-20 Radiopacity Testing Standards
Tracking the devices and confirmation of positioning in vivo is essential, therefore the level of visibility of product with X-ray techniques such as fluoroscopy, angiography, X-ray computed tomography (CT), and DEXA (dual energy X-ray absorptiometry) must be determined. Medical Murray can assist you in conducting radiopacity testing and other fluoroscopy services to improve catheter performance and function. We can help evaluate new or existing medical device projects.
Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, and (b) quantitatively determining the specific difference in pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.
We also offer additional testing with our versatile mini C-arm imaging technology including:
- Imaging artifact analysis
- Catheter inspection
- Visualization of internal components or defects
- Product performance testing
- Deployment testing
- Bench testing for physician directed studies
Testing Method A
Radiopacity is determined by qualitatively comparing the visibility of a test specimen to a user-defined standard.
Testing Method B
Radiopacity is determined by quantitatively comparing the visibility of a test specimen to a user-defined standard. Pixel density measurements are taken for informational purposes.