ASTM F640-12

Standard Test Methods for Determining Radiopacity for Medical Use

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.
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.

General Information

• Status: Historical
• Publication Date: 14-Dec-2012
• 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

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 12
Standard Test Methods for
1
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.
1. Scope* F647 Practice for Evaluating and Specifying Implantable
Shunt Assemblies for Neurosurgical Application
1.1 These test methods cover the determination of the
radiopacity of materials and products utilizing X-ray based
3. Terminology
techniques, including fluoroscopy, angiography, CT (computed
3.1 Definitions—For definitions of terms relating to X-ray
tomography) and DEXA (dual energy X-ray absorptiometry),
procedures, refer to Terminology E1316.
also known as DXA, The results of these measurements are an
3.2 Descriptions of Terms:
indication of the likelihood of locating the product within the
3.2.1 body mimic, n—a piece of material, a phantom, a
human body.
cadaver, or an animal utilized to mimic the appropriate X-ray
1.2 Radiopacity is determined by (a) qualitatively compar-
attenuation through a particular part of the human body.
ing image(s) of a test specimen and a user-defined standard,
3.2.2 digital resolution, n—the number of pixels per inch in
with or without the use of a body mimic, or (b) quantitatively
a digital image.
determining the specific difference in optical density or pixel
3.2.2.1 Discussion—This may be different in the x and y
intensity between the image of a test specimen and the image
directions
of a user-defined standard, with or without the use of a body
mimic. 3.2.3 grayscale range, n—the number of levels in pixel
intensity resolved in the digital image.
1.3 The values stated in SI units are to be regarded as
3.2.3.1 Discussion—This is normally 256 levels in an 8-bit
standard. No other units of measurement are included in this
grayscale image
standard.
3.2.4 optical density, n—the range of values of optical
1.4 This standard does not purport to address all of the
density as measured by a densitometer; in this test method the
safety concerns, if any, associated with its use. It is the
expected range is 0.50 to 1.50.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- 3.2.5 optical density difference, n—the difference in optical
bility of regulatory limitations prior to use. density units between two regions or objects in an image,
reported to at least two digits to the right of the decimal point.
2. Referenced Documents
3.2.6 pixel intensity, n—the grayscale level of a pixel
2
2.1 ASTM Standards:
between 0 and 255, as determined by the digital analysis
B209 Specification for Aluminum and Aluminum-Alloy
program.
Sheet and Plate
3.2.7 pixel intensity difference, n—the difference in gray-
D3182 PracticeforRubber—Materials,Equipment,andPro-
scale level between two regions or objects in an image,
cedures for Mixing Standard Compounds and Preparing
reported to within the significance capability of the digital
Standard Vulcanized Sheets
analysis program.
E94 Guide for Radiographic Examination
3.2.8 user-defined standard, n—a comparison standard se-
E1316 Terminology for Nondestructive Examinations
lected by the user.
3.2.8.1 Discussion—This standard may be an existing medi-
1 cal product or a material in a particular form, it may be a
These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and are the direct responsibility of commercially available standard, or it may be one developed
Subcommittee F04.15 on Material Test Methods.
by the user.
Current edition approved Dec. 15, 2012. Published January 2013. Originally
approved in 1979. Last previous edition approved in 2007 as F640 – 07. DOI:
4. Summary of Test Methods
10.1520/F0640-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1 The test specimen is placed so it sits at or near the
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
middle of the X-ray image area in the X-ray imaging system.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. X-ray images are made at specified voltages, times, and
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F640 − 12
currents that are typical of those used in the X-ray diagnosis of National Institute of Standards and Technology. This is not
humans. Preferred settings are those appropriate for the prod- r
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F640 − 07 F640 − 12
Standard Test Methods for
1
Determining Radiopacity for Medical Use
This standard is issued under the fixed designation F640; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
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*
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, DEXA (dual energy X-ray absorptiometry), 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 Radiopacity is determined by (aof tests described, differing ) qualitatively
comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, or (bin the method
of determining radiopacity.) 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.
1.2.1 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. 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
2
2.1 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
3. Terminology
3.1 Definitions—For definitions of terms relating to X-ray procedures, refer to Terminology E1316.
3.2 Descriptions of Terms:
1
These test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved March 1, 2007Dec. 15, 2012. Published March 2007January 2013. Originally approved in 1979. Last previous edition approved in 20002007
as F640 – 79 (2000).F640 – 07. DOI: 10.1520/F0640-07.10.1520/F0640-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F640 − 12
3.2.1 body mimic, n—a piece of material, a phantom, a cadaver, or an animal utilized to mimic the appropriate X-ray atte
...