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  • ASTM
    F640-12 Standard Test Methods for Determining Radiopacity for Medical Use
    Edition: 2012
    $91.10
    Unlimited Users per year

Description of ASTM-F640 2012

ASTM F640 - 12

Standard Test Methods for Determining Radiopacity for Medical Use

Active Standard ASTM F640 | Developed by Subcommittee: F04.15

Book of Standards Volume: 13.01




ASTM F640

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. 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.


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/F0640-12

ASTM International is a member of CrossRef.

ASTM F640

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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