ASTM F640-07

Standard Test Methods for Determining Radiopacity for Medical Use

SIGNIFICANCE AND USE
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.  
These methods allow for both qualitative and quantitative evaluation in different comparative situations.
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, also known as DXA, (dual energy X-ray absorptiometry). The results of these measurements are an indication of the likelihood of locating the product within the human body.
1.2 Types of Tests - There are three methods of tests described, differing in the method of determining radiopacity.
1.2.1 Method A - Radiopacity is (1) qualitatively determined by viewing image(s) of a test sample and the image background, with or without the use of a body mimic, or ( 2) quantitatively determined as a specific difference in optical density or pixel intensity between the image of a test sample and the image background, with or without the use of a body mimic.
1.2.2 Method B - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard without the use of a body mimic, or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard without the use of a body mimic.
1.2.3 Method C - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard with the use of body mimic or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard with the use of a body mimic.
1.3 The values stated in SI units are to be regarded as the standard.
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.

General Information

• Status: Historical
• Publication Date: 28-Feb-2007
• ICS: 11.120.01 - Pharmaceutics in general
• ICS: 83.080.01 - Plastics in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F640-79(2000) - Standard Test Methods for Radiopacity of Plastics for Medical Use
• Effective Date: 01-Mar-2007
• Referred By: ASTM F1828-22 - Standard Specification for Ureteral Stents
• Effective Date: 01-Mar-2007
• Referred By: ASTM F647-22 - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• Effective Date: 01-Mar-2007

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F640 − 07
StandardTest Methods for
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Determining Radiopacity for Medical Use
ThisstandardisissuedunderthefixeddesignationF640;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope* priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 These test methods cover the determination of the
radiopacity of materials and products utilizing X-ray based
2. Referenced Documents
techniques, including fluoroscopy, angiography, CT(computed
2
2.1 ASTM Standards:
tomography) and DEXA, also known as DXA, (dual energy
B209 Specification for Aluminum and Aluminum-Alloy
X-ray absorptiometry). The results of these measurements are
Sheet and Plate
an indication of the likelihood of locating the product within
D3182 PracticeforRubber—Materials,Equipment,andPro-
the human body.
cedures for Mixing Standard Compounds and Preparing
1.2 Types of Tests—There are three methods of tests
Standard Vulcanized Sheets
described, differing in the method of determining radiopacity.
E94 Guide for Radiographic Examination
1.2.1 Method A—Radiopacity is (1) qualitatively deter-
E1316 Terminology for Nondestructive Examinations
mined by viewing image(s) of a test sample and the image
F647 Practice for Evaluating and Specifying Implantable
background, with or without the use of a body mimic, or (2)
Shunt Assemblies for Neurosurgical Application
quantitatively determined as a specific difference in optical
density or pixel intensity between the image of a test sample
3. Terminology
and the image background, with or without the use of a body
3.1 Definitions—For definitions of terms relating to X-ray
mimic.
procedures, refer to Terminology E1316.
1.2.2 Method B—Radiopacity is determined by (1) qualita-
3.2 Descriptions of Terms:
tively comparing image(s) of a test sample and a user-defined
3.2.1 body mimic, n—a piece of material, a phantom, a
standard without the use of a body mimic, or (2) quantitatively
cadaver, or an animal utilized to mimic the appropriate X-ray
determining the specific difference in optical density or pixel
attenuation through a particular part of the human body.
intensity between the image of a test sample and the image of
3.2.2 digital resolution, n—the number of pixels per inch in
a user-defined standard without the use of a body mimic.
a digital image.
1.2.3 Method C—Radiopacity is determined by (1) qualita-
3.2.2.1 Discussion—This may be different in the x and y
tively comparing image(s) of a test sample and a user-defined
directions
standard with the use of body mimic or (2) quantitatively
determining the specific difference in optical density or pixel
3.2.3 grayscale range, n—the number of levels in pixel
intensity between the image of a test sample and the image of
intensity resolved in the digital image.
a user-defined standard with the use of a body mimic.
3.2.3.1 Discussion—This is normally 256 levels in an 8-bit
grayscale image
1.3 The values stated in SI units are to be regarded as the
standard. 3.2.4 optical density, n—the range of values of optical
density as measured by a densitometer; in this test method the
1.4 This standard does not purport to address all of the
expected range is 0.50 to 1.50.
safety concerns, if any, associated with its use. It is the
3.2.5 optical density difference, n—the difference in optical
responsibility of the user of this standard to establish appro-
density units between two regions or objects in an image,
reported to at least two digits to the right of the decimal point.
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These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and are the direct responsibility of
2
Subcommittee F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 1, 2007. Published March 2007. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1979. Last previous edition approved in 2000 as F640 – 79 (2000). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F0640-07. the ASTM website.
*A Summary of Changes section appears at the end of this standard
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F640 − 07
3.2.6 pixel intensity, n—the grayscale level of a pixel 6.3.7 Step Wedge—A step wedge may be used if it has the
between 0 and
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