ASTM-F640 › Historical Revision Information
Standard Test Methods for Determining Radiopacity for Medical Use
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Scope
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.
Keywords
implants; plastic surgical devices; polymers; surgical applications; radiopacity; test methods; surgical implants; ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.01 (Plastics in general)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.120.01 (Pharmaceutics in general)
83.080.01 (Plastics in general)
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Document Number
ASTM-F640
Revision Level
DOD ADOPTION
Status
Superseded
Modification Type
Reapproval
Publication Date
April 15, 1981
Document Type
Test Method
Page Count
1 page
Committee Number
F04.15