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ASTM F640-07

Historical Revision

Standard Test Methods for Determining Radiopacity for Medical Use

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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.


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 body.

These methods allow for both qualitative and quantitative evaluation in different comparative situations.

SDO ASTM: ASTM International
Document Number F640
Publication Date March 1, 2007
Language en - English
Page Count 4
Revision Level 07
Supercedes
Committee F04.15
Publish Date Document Id Type View
March 1, 2023 F0640-23 Revision
Oct. 1, 2020 F0640-20 Revision
Dec. 15, 2012 F0640-12 Revision
March 1, 2007 F0640-07 Revision
Jan. 1, 2000 F0640-79R00 Reaffirmation