Standard Test Methods for Radiopacity of Plastics for Medical Use
|Publication Date:||26 October 1979|
|ICS Code (Plastics in general):||83.080.01|
|ICS Code (Pharmaceutics in general):||11.120.01|
1.1 These test methods cover the determination, by radiography, of the radiopacity of plastic in the form of film, sheet, rod, tube, and moldings. The results of these measurements are an indication of the likelihood of locating the plastic part within the human body.
1.2 Types of Tests--There are three methods of tests described, differing in the method of calculating radiopacity.
1.2.1 Method A--Radiopacity is determined as a specific difference in optical density between the image of the plastic and the background on the X-ray film or equivalent.
1.2.2 Method B--Radiopacity is determined by comparing the images of the test piece and of a standard piece simulating the medical device.
1.2.3 Method C--The intrinsic radiopacity of a plastic is determined by measurements made on the image of a slab of a specific thickness of the formulation.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.