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Significance and Use
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without the use of a body mimic should be used with caution as the relative radiopacity can be affected when imaging through the human body.
5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
B209 Specification for Aluminum and Aluminum-Alloy Sheet and Plate
D3182 Practice for RubberMaterials, Equipment, and Procedures for Mixing Standard Compounds and Preparing Standard Vulcanized Sheets
E1316 Terminology for Nondestructive Examinations
F647 Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.01 (Plastics in general)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F640-20, Standard Test Methods for Determining Radiopacity for Medical Use, ASTM International, West Conshohocken, PA, 2020, www.astm.orgBack to Top