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ASTM International - ASTM F640-07

Standard Test Methods for Determining Radiopacity for Medical Use

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Organization: ASTM International
Publication Date: 1 March 2007
Status: inactive
Page Count: 4
ICS Code (Pharmaceutics in general): 11.120.01
ICS Code (Plastics in general): 83.080.01
significance And Use:

These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human... View More

scope:

1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA, also known as DXA, (dual energy X-ray absorptiometry). The results of these measurements are an indication of the likelihood of locating the product within the human body.

1.2 Types of Tests - There are three methods of tests described, differing in the method of determining radiopacity.

1.2.1 Method A - Radiopacity is (1) qualitatively determined by viewing image(s) of a test sample and the image background, with or without the use of a body mimic, or ( 2) quantitatively determined as a specific difference in optical density or pixel intensity between the image of a test sample and the image background, with or without the use of a body mimic.

1.2.2 Method B - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard without the use of a body mimic, or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard without the use of a body mimic.

1.2.3 Method C - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard with the use of body mimic or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard with the use of a body mimic.

1.3 The values stated in SI units are to be regarded as the standard.

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.

Document History

October 1, 2020
Standard Test Methods for Determining Radiopacity for Medical Use
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA...
December 15, 2012
Standard Test Methods for Determining Radiopacity for Medical Use
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA...
ASTM F640-07
March 1, 2007
Standard Test Methods for Determining Radiopacity for Medical Use
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA,...
January 1, 2000
Standard Test Methods for Radiopacity of Plastics for Medical Use
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...
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