Radiopacity testing per ASTM F640
Service Detail from Cambridge Polymer Group, Inc.
Cambridge Polymer Group now offers quantitative radiopacity analysis compliant with ASTM F640 "Standard Test Methods for Determining the Radiopacity for Medical Use." In this method, the medical device is imaged with a conventional X-ray system, and the image density contrast is quantified with a densitometer.
Determination of radiopacity is important in the biomedical and associated fields. Obviously, for implantable devices being able to track the device in vivo is vital, but equally surfaces such as operating room tables that support patients within an x-ray beam must also be characterized.
Although the former is largely covered by tests such as ASTM F640, the latter is defined with the Federal Regulations within the US (21CFR part 1020). Cambridge Polymer Group has developed refinements of these standards, completely compliant with the standards but extending the analysis more robustly in to the digital age.