ASTM F640-23
(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
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Standards Content (Sample)
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.
Designation: F640 − 23
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* Alloy Sheet and Plate
D3182 Practice for Rubber—Materials, Equipment, and Pro-
1.1 These test methods cover the determination of the
cedures for Mixing Standard Compounds and Preparing
radiopacity of materials and products utilizing X-ray based
Standard Vulcanized Sheets
techniques, including fluoroscopy, angiography, CT (computed
E94/E94M Guide for Radiographic Examination Using In-
tomography), and DEXA (dual energy X-ray absorptiometry),
dustrial Radiographic Film
also known as DXA, The results of these measurements are an
E1316 Terminology for Nondestructive Examinations
indication of the likelihood of locating the product within the
F647 Practice for Evaluating and Specifying Implantable
human body.
Shunt Assemblies for Neurosurgical Application
1.2 Radiopacity is determined by (a) qualitatively compar-
ing image(s) of a test specimen and a user-defined standard,
3. Terminology
with or without the use of a body mimic; or (b) quantitatively
determining the specific difference in optical density or pixel
3.1 Definitions—For definitions of terms relating to X-ray
intensity between the image of a test specimen and the image procedures, refer to Terminology E1316.
of a user-defined standard, with or without the use of a body
3.2 Descriptions of Terms:
mimic.
3.2.1 body mimic, n—a piece of material, a phantom, a
1.3 The values stated in SI units are to be regarded as cadaver, or an animal utilized to mimic the appropriate X-ray
standard. No other units of measurement are included in this attenuation through a particular part of the human body.
standard.
3.2.2 digital resolution, n—the number of pixels per inch in
1.4 This standard does not purport to address all of the
a digital image.
safety concerns, if any, associated with its use. It is the
3.2.2.1 Discussion—This may be different in the x and y
responsibility of the user of this standard to establish appro-
directions.
priate safety, health, and environmental practices and deter-
3.2.3 grayscale range, n—the number of levels in pixel
mine the applicability of regulatory limitations prior to use.
intensity resolved in the digital image.
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3.2.3.1 Discussion—This range is normally 256 levels in an
ization established in the Decision on Principles for the
8-bit grayscale image, but 16-bit grayscale images can also be
Development of International Standards, Guides and Recom-
used.
mendations issued by the World Trade Organization Technical
3.2.4 pixel intensity, n—the grayscale level of a pixel
Barriers to Trade (TBT) Committee.
between 0 and 255, as determined by the digital analysis
program.
2. Referenced Documents
2
3.2.5 pixel intensity difference, n—the difference in gray-
2.1 ASTM Standards:
B209/B209M Specification for Aluminum and Aluminum- scale level between two regions or objects in an image,
reported to within the significance capability of the digital
analysis program.
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 3.2.6 user-defined standard, n—a comparison standard se-
Subcommittee F04.15 on Material Test Methods.
lected by the user. This standard could be a reference material
Current edition approved March 1, 2023. Published March 2023. Originally
or a predicate device.
approved in 1979. Last previous edition approved in 2020 as F640 – 20. DOI:
10.1520/F0640-23.
3.2.6.1 Discussion—This standard may be an existing medi-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
cal product or a material in a particular form, it may be a
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
commercially available standard, or it may be one developed
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. by the user.
*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 − 23
4. Summary of Test Methods 6.
...
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 − 20 F640 − 23
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), 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.
2. Referenced Documents
2
2.1 ASTM Standards:
B209B209/B209M Specification for Aluminum and Aluminum-Alloy Sheet and Plate (Metric) B0209_B0209M
D3182 Practice for Rubber—Materials, Equipment, and Procedures for Mixing Standard Compounds and Preparing Standard
Vulcanized Sheets
E94/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 Oct. 1, 2020March 1, 2023. Published November 2020March 2023. Originally approved in 1979. Last previous edition approved in 20122020
as F640 – 12.F640 – 20. DOI: 10.1520/F0640-20.10.1520/F0640-23.
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 − 23
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 directions.
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, but 16-bit grayscale images can also be used.
3.2.4 pixel intensity, n—the grayscale level of a pixel between 0 and 255, as determined by the digital analysis program.
3.2.5 pixel intensity difference, n—the difference in grayscale level between two regions or objects in an image, reported to within
the significance capability of the digital analysis program.
3.2.6 user-defined standard, n—a comparison standard selected by the user. This standard could be a reference material or a
predicate device.
3.2.6.1 Discussion—
This
...
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