ASTM F640 Standard Test Method for Determining Radiopacity for Medical Use

Medical Device Tests

ASTM F640 Standard Test Method for Determining Radiopacity for Medical Use

This standard covers the determination of radiopacity of materials and products using X-ray-based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual energy X-ray absorptiometry), also known as DXA. These measurements are an indication of the probability of finding the product in the human body.

ASTM F640 Standard Test Method for Determining Radiopacity for Medical Use


Radiopacity is determined by qualitative comparison of images of a test sample and a user-defined standard, with or without a body mimic; or quantitative determination of the specific difference in optical density or pixel density between the image of a test sample and the image of a user-defined standard, with or without a body mimic.


Values ​​stated in SI units should be accepted as standard.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.


EUROLAB assists manufacturers with ASTM F640 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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