ASTM F640-20
(Test Method)Standard Test Methods for Determining Radiopacity for Medical Use
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, 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.
General Information
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 20
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.
1. Scope* D3182 Practice for Rubber—Materials, Equipment, and Pro-
cedures for Mixing Standard Compounds and Preparing
1.1 These test methods cover the determination of the
Standard Vulcanized Sheets
radiopacity of materials and products utilizing X-ray based
E94/E94M Guide for Radiographic Examination Using In-
techniques, including fluoroscopy, angiography, CT (computed
dustrial Radiographic Film
tomography), and DEXA (dual energy X-ray absorptiometry),
E1316 Terminology for Nondestructive Examinations
also known as DXA, The results of these measurements are an
F647 Practice for Evaluating and Specifying Implantable
indication of the likelihood of locating the product within the
Shunt Assemblies for Neurosurgical Application
human body.
1.2 Radiopacity is determined by (a) qualitatively compar- 3. Terminology
ing image(s) of a test specimen and a user-defined standard,
3.1 Definitions—For definitions of terms relating to X-ray
with or without the use of a body mimic; or (b) quantitatively
procedures, refer to Terminology E1316.
determining the specific difference in optical density or pixel
3.2 Descriptions of Terms:
intensity between the image of a test specimen and the image
3.2.1 body mimic, n—a piece of material, a phantom, a
of a user-defined standard, with or without the use of a body
cadaver, or an animal utilized to mimic the appropriate X-ray
mimic.
attenuation through a particular part of the human body.
1.3 The values stated in SI units are to be regarded as
3.2.2 digital resolution, n—the number of pixels per inch in
standard. No other units of measurement are included in this
a digital image.
standard.
3.2.2.1 Discussion—This may be different in the x and y
1.4 This standard does not purport to address all of the directions.
safety concerns, if any, associated with its use. It is the
3.2.3 grayscale range, n—the number of levels in pixel
responsibility of the user of this standard to establish appro-
intensity resolved in the digital image.
priate safety, health, and environmental practices and deter-
3.2.3.1 Discussion—This range is normally 256 levels in an
mine the applicability of regulatory limitations prior to use.
8-bit grayscale image, but 16-bit grayscale images can also be
1.5 This international standard was developed in accor-
used.
dance with internationally recognized principles on standard-
3.2.4 pixel intensity, n—the grayscale level of a pixel
ization established in the Decision on Principles for the
between 0 and 255, as determined by the digital analysis
Development of International Standards, Guides and Recom-
program.
mendations issued by the World Trade Organization Technical
3.2.5 pixel intensity difference, n—the difference in gray-
Barriers to Trade (TBT) Committee.
scale level between two regions or objects in an image,
2. Referenced Documents
reported to within the significance capability of the digital
2
analysis program.
2.1 ASTM Standards:
B209 Specification for Aluminum and Aluminum-Alloy
3.2.6 user-defined standard, n—a comparison standard se-
Sheet and Plate
lected by the user. This standard could be a reference material
or a predicate device.
1
These test methods are under the jurisdiction of ASTM Committee F04 on 3.2.6.1 Discussion—This standard may be an existing medi-
Medical and Surgical Materials and Devices and are the direct responsibility of
cal product or a material in a particular form, it may be a
Subcommittee F04.15 on Material Test Methods.
commercially available standard, or it may be one developed
Current edition approved Oct. 1, 2020. Published November 2020. Originally
by the user.
approved in 1979. Last previous edition approved in 2012 as F640 – 12. DOI:
10.1520/F0640-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4. Summary of Test Methods
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
4.1 The test specimen is placed so it sits at or near the
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. middle of the X-ray image area in the X-ray imaging system.
*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 − 20
X-ray images are made at specified v
...
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 − 12 F640 − 20
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.
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)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,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 safety, health, and healthenvironmental 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
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
E94E94/E94M Guide for Radiographic Examination Using Industrial Radiographic Film
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 Dec. 15, 2012Oct. 1, 2020. Published January 2013November 2020. Originally approved in 1979. Last previous edition approved in 20072012
as F640 – 07.F640 – 12. DOI: 10.1520/F0640-12.10.1520/F0640-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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 − 20
3.2.1 body mimic, n—a piece of material, a phantom, a cadaver, or an animal utilized to mimic the appropriate X-ray attenuation
through a particular part of the human body.
3.2.2 digital resolution, n—the number of pixels per inch in a digital image.
3.2.2.1 Discussion—
This may be different in the x and y directionsdirections.
3.2.3 grayscale range, n—the number of levels in pixel intensity resolved in the digital image.
3.2.3.1 Discussion—
This range is normally 256 levels in an 8-bit grayscale image image, but 16-bit grayscale images can also be used.
3.2.4 optical density, n—the range of values of optical density as measured by a densitometer; in this test method the expected
range is 0.50 to 1.50.
3.2.5 optical density difference, n—the difference in optical density units between two regions or objects in an image, reported to
at least two digits to the right of the decimal point.
3.2.4 pixel intensity, n—the grayscale level of a pixel between 0 and 255, as determined by the digital analysis program.
3.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.