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

ASTM-F640 - 2012 EDITION - CURRENT
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Standard Test Methods for Determining Radiopacity for Medical Use
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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 (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.

1.2 Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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; radiopacity; surgical applications; surgical devices; surgical implants; test methods; X-ray; 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-F640-12

Revision Level

2012 EDITION

Status

Current

Modification Type

Revision

Publication Date

Jan. 1, 2013

Document Type

Test Method

Page Count

4 pages

Committee Number

F04.15