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ASTM-F640 2007

$35.75

F640-07 Standard Test Methods for Determining Radiopacity for Medical Use

Published By Publication Date Number of Pages
ASTM 2007 5
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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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Summary of Test Methods
Significance and Use
Apparatus
Test Specimens
Imaging Conditions
Procedure—Method A
3 Procedure—Method B
Procedure—Method C
Report
Precision and Bias
4 Keywords
X1. RATIONALE
X1.1
X1.2
X1.3
ASTM-F640 2007
$35.75