ASTM F640-07
Historical Standard: ASTM F640-07 Standard Test Methods for Determining Radiopacity for Medical Use
SUPERSEDED (see Active link, below)
ASTM F640
1. 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
B209 Specification for Aluminum and Aluminum-Alloy Sheet and Plate
D3182 Practice for Rubber--Materials, Equipment, and Procedures for Mixing Standard Compounds and Preparing Standard Vulcanized Sheets
E94 Guide for Radiographic Examination
E1316 Terminology for Nondestructive Examinations
F647 Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Keywords
implants; radiopacity; surgical applications; surgical devices; surgical implants; test methods; X-ray;
ICS Code
ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.01 (Plastics in general)
DOI: 10.1520/F0640-07
ASTM International is a member of CrossRef.