ASTM F640-79(2000)
Historical Standard: ASTM F640-79(2000) Standard Test Methods for Radiopacity of Plastics for Medical Use
SUPERSEDED (see Active link, below)
ASTM F640
1. 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.
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/F0640-79R00
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