ASTM F640-23 Radiopacity Testing Standards
Creating trackable devices that can be easily found in vivo is essential. The device’s level of visibility of with X-ray techniques such as fluoroscopy, angiography, X-ray computed tomography (CT), and DEXA (dual energy X-ray absorptiometry) must be determined before safe use.
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
Qualitative Analysis
Radiopacity is determined by qualitatively comparing the visibility of a test specimen to a user-defined standard.
Testing Method B
Quantitative Analysis
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.