ASTM F640-20
Standard Test Methods for Determining Radiopacity for Medical Use

Standard No.

ASTM F640-20

Release Date

2020

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F640-23

Latest

ASTM F640-23

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, 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.

ASTM F640-20 Referenced Document

• ASTM B209 Standard Specification for Aluminum and Aluminum- Alloy Sheet and Plate
• ASTM D3182 Standard Practice for Rubber-Materials, Equipment, and Procedures for Mixing Standard Compounds and Preparing Standard Vulcanized Sheets
• ASTM E1316 Standard Terminology for Nondestructive Examinations*， 2024-02-01 Update
• ASTM E94/E94M Standard Guide for Radiographic Examination Using Industrial Radiographic Film*， 2022-12-01 Update
• ASTM F647 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

ASTM F640-20 history

• 2023 ASTM F640-23 Standard Test Methods for Determining Radiopacity for Medical Use
• 2020 ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
• 2012 ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use
• 2007 ASTM F640-07 Standard Test Methods for Determining Radiopacity for Medical Use
• 1979 ASTM F640-79(2000) Standard Test Methods for Radiopacity of Plastics for Medical Use