Designation: F 640 79 (Reapproved 2000)

Standard Test Methods for

Radiopacity of Plastics for Medical Use1

This standard is issued under the fixed designation F 640; 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 (e) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.

E 7 Terminology Relating to Metallography5

E 94 Guide for Radiographic Testing6
E 135 Terminology Relating to Analytical Chemistry for
Metals, Ores, and Related Materials7
E 142 Test Method for Controlling Quality of Radiographic
Testing8
F 647 Practice for Evaluating and Specifying Implantable
Shunt Assemblies for Neurosurgical Application9

1. Scope
1.1 These test methods cover the determination, by radiography, of the radiopacity of plastic in the form of film, sheet,
rod, tube, and moldings. The results of these measurements are
an indication of the likelihood of locating the plastic part
within the human body.
1.2 Types of Tests There are three methods of tests
described, differing in the method of calculating radiopacity.
1.2.1 Method ARadiopacity is determined as a specific
difference in optical density between the image of the plastic
and the background on the X-ray film or equivalent.
1.2.2 Method BRadiopacity is determined by comparing
the images of the test piece and of a standard piece simulating
the medical device.
1.2.3 Method CThe intrinsic radiopacity of a plastic is
determined by measurements made on the image of a slab of a
specific thickness of the formulation.
1.3 The values stated in SI units are to be regarded as the
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.

3. Terminology
3.1 DefinitionsFor definitions of terms relating to X-ray
procedures, refer to Guide E 94 and Test Method E 142.
3.2 Descriptions of Terms:
3.2.1 optical densityin photographic photometry, the
logarithm to the base 10 of the ratio of the incident light to the
transmitted light (see Terminology E 135). The range of values
of optical density expected in this test method is 0.5 to 1.5.
3.2.2 contrastin this test method, contrast is the difference
between optical density measurements made on the background (nominally 1.0 optical density) and on the test specimen.
3.2.3 penetrametera device employed to obtain evidence
on a radiograph that the technique used is satisfactory. It is not
intended for use in judging the size of discontinuities nor for
establishing acceptance limits for materials or products.
3.2.4 intrinsic radiopacityfor this application, where the
plastic is part of a medical device, the X-ray linear absorption
coefficient is important. The following definition is excerpted
from Terminology E 7:
absorption coefficientspecific factor characteristic of a
substance on which its absorption radiation depends. The rate
of decrease of the natural logarithm of the intensity of a parallel
beam per unit distance traversed in a substance. For X rays, the
linear absorption coefficient is the natural logarithm of the ratio
of the incident intensity of an X-ray beam incident intensity of
a beam of X rays, It the transmitted intensity, and X the

2. Referenced Documents
2.1 ASTM Standards:
B 209 Specification for Aluminum and Aluminum-Alloy
Sheet and Plate2
D 1898 Practice for Sampling of Plastics3
D 3182 Practice for RubberMaterials, Equipment, and
Procedures for Mixing Standard Compounds and Preparing Standard Vulcanized Sheets4

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. 26, 1979. Published January 1980.
2
Annual Book of ASTM Standards, Vol 02.02.
3
Annual Book of ASTM Standards, Vol 08.01.
4
Annual Book of ASTM Standards, Vol 09.01.

Annual
Annual
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Annual
8
Annual
9
Annual
6

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Book
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ASTM
ASTM
ASTM
ASTM
ASTM

Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

Standards,
Standards,
Standards,
Standards,
Standards,

Vol
Vol
Vol
Vol
Vol

03.01.
03.03.
03.05.
03.03.
13.01.

F 640
alloy). The comparison standard of Method B (7.1) shall be of
the same metal, unless otherwise specified.
6.4.2 Aluminum Sheet A 10.0 6 0.15-mm thick aluminum
sheet shall be used on top of the test specimen for all tests. If
so specified in the standard for the medical device, a 15.0 6
0.15-mm thick sheet shall be placed on top of the test
specimen.
6.4.3 Step WedgeA step wedge may be used instead of the
aluminum sheet specified in 6.4.2, if it has the requisite
thickness steps.
6.5 Rubber Blankets Blankets incorporating X-ray absorbers may be used to mask areas outside that covered by the
penetrameter (this prevents undercutting). Lead sheets may
also be used for masking.
6.6 Back-Scatter Protection, as described in Guide E 94.
6.7 Densitometer The densitometer shall be capable of
measuring the optical density over the range from 0.0 to 3.0
optical density units, minimum. It shall have a measuring
accuracy of 6 0.02 optical density units or better. The
densitometer shall have been calibrated within 6 months
previously by a method and calibration standard traceable to
the U.S. National Bureau of Standards.
6.8 Step Tablet, 10 for calibrating densitometers.

thickness of the absorbing material, then:

It 5 Ie exp ~2X!.

Here is the linear absorption coefficient. The mass absorption is given by /r where r is the density.
3.2.5 attenuationloss of energy per unit distance.
4. Summary of Test Methods
4.1 The plastic specimen is laid on the cassette in the Xray
apparatus and a 10-mm thick sheet of aluminum is placed on
top of the specimen (or 15-mm thick, if so specified). The
apparatus is equivalent to that used in a hospital. Radiographs
are made at specified voltages, times, and currents that are
typical of those used in the X-ray diagnosis of humans. The
radiopacity of the material or medical device is evaluated in
terms of the criteria described for the test method selected.
Calibration is achieved by using both a standard specimen and
an X-ray optical density standard.
5. Significance and Use
5.1 Plastics, being composed principally of chemical elements of low atomic weight, have little opacity to X rays.
Compounds of elements of higher atomic weight are deliberately mixed into plastics to obtain radiopacity.
5.2 These methods are intended to determine whether the
plastic part has the degree of radiopacity specified for its
application as a medical device in the human body.
5.3 Degree of Contrast:
5.3.1 Using Method A, it is recommended that a specific
difference in optical density between the background of 0.8 to
1.2 optical density (3.2.1) and the image of the test specimen
be required in any specification for a radiopaque medical
device.
5.3.2 Method B requires that the image of the medical
device, or the image of the section of the medical device that
is radiopaque, give as much contrast (same background optical
density as above) as the image of a comparison standard
simulating the medical device.

7. Comparison Standards
7.1 Method BThe comparison standard shall be of similar
dimensions to the medical device. Its exact dimensions and
composition (see 6.4.1) shall be specified in the standard for
the medical device.
7.2 Method CThe material of the comparison standard
shall be Type 1100 aluminum (6.4.1), 2.0 mm thick, 25 mm
wide, and 150 mm long.
8. Sampling
8.1 Sample fabricated stock shapes or molded items in
accordance with Practice D 1898.
9. Test Specimens
9.1 Film or Sheet The specimen shall be at least 150 mm
long and 25 6 1 mm wide. (For this specimen and the
following it is assumed that the penetrameter covers an area of
approximately 150 by 50 mm.)
9.2 Rod or Tubing The specimen shall be at least 150 mm
long.
9.3 Molded Parts If the molded part has dimensions small
with respect to the area covered by the penetrameter, then
several moldings shall be placed under the penetrameter.
9.4 Slab for Method CThe dimensions of the specimen of
the plastic shall be 2.0 by 25 by 150 mm.

NOTE 1It is expected that the dimensions and composition of the

comparison standard will be specified in the standard for the medical
device (see Appendix X1).

5.3.3 In Method C, the intrinsic radiopacity of a plastic is

determined by comparison with an equal thickness of aluminum, and by the calculation of the relative linear X-ray
attenuation (3.2.5) of the plastic based on measurements of
optical density of the image of the sample, and of the image of
the comparison aluminum piece.
6. Apparatus
6.1 X-Ray Machine, a medical-type (minimally full wave
rectified).
6.2 Inherent X-Ray Beam Filtration, 2.5-mm aluminum
equivalent minimum.
6.3 X-Ray Film, par-speed grade, used with par-speed intensifying screens. A grid may be used.
6.4 Penetrameters:
6.4.1 MaterialThe aluminum sheet on top of the test
specimen and the step wedge (if used) shall be 99+ % aluminum in accordance with Specification B 209 (typically, 1100

NOTE 2A 2.0-mm thick sheet is often molded especially for testing:

for example, the description of sample in Practice D 3182.

10. Conditioning
10.1 The test shall be performed at Class 1 conditions
(11.2.1), unless otherwise specified.
10
SRM 1001 has been found suitable for this purpose and is available from
National Bureau of Standards, Office of Standard Reference Materials, Washington,
DC 20234.

F 640
density of the image of the test specimen is less than, equal to,
or greater than the optical density of the image of the
comparison standard, as measured in 12.2. The radiopacity of
the medical device meets the requirements if the optical density
of its image on the developed film is less or equal to that of the
comparison standard.
14.3 Method CCalculate the percent relative linear attenuation coefficient, a, as follows:

10.2 If other combinations of kilovolt peaks and

milliampereseconds are used, these exact conditions shall be
described in the test report.
11. ProcedureMethod A
11.1 Place the plastic test specimens on a cassette containing the X-ray film and the intensifying screens. Cover the test
specimen with the penetrameter.
11.2 X-Ray Exposure The recommended focus-film distance for all classes of exposure is 1000 6 20 mm.
11.2.1 Class 1The conditions for Class 1 exposure shall
be:

a 5

~B 2 S!
3 100
~B 2 A!

where:
B = background optical density, in the range 0.80 to 1.20,
A = optical density under the 2.0-mm thickness of aluminum, and
S = optical density of the image of the sample.

80 to 85 kVp ~full2wave rectified!

3.0 mAs ~must be varied!

11.2.2 The exposure shall be of such duration that an optical

density of 1.0 6 0.2 is obtained through a 10-mm thickness of
aluminum (or 15.0 mm, if specified in the standard for the
medical device).
11.3 Film Development Develop the X-ray film in accordance with the manufacturers instructions.
11.4 Measurement of Optical Density:
11.4.1 BackgroundMeasure the background optical density to determine whether it is in the specified range, 0.8 to 1.2.
11.4.2 Medical Device ImageMeasure the optical density
of the image of the medical device.

15. Report
15.1 The report shall include the following:
15.1.1 Test conditions, including the class, as described in
10, or the specific values of kVp and mAs shall be listed. The
focus-film distance shall also be listed.
15.1.2 Specification requirements, including the thickness
of aluminum on top of the test specimen, the required contrast
(Method A), the size of the comparison standard (Method B),
or the percent relative linear attenuation coefficient (Method
C), as listed in the requirements of the standard specification
for the medical device. The number and title of the medical
device specification shall also be listed.
15.1.3 Sample description, including name of manufacturer,
type of device or plastic part, Catalog number or formulation
number, dimensions of the test specimen, diameter, wall
thickness, etc., and type of radiopaque additive and how it
occurs in the part, such as a uniform dispersion, line of specific
cross section, etc.,
15.1.4 Optical density readings for all optical density measurements as described in 11.4, 12.2, and 13, and
15.1.5 Calculations, reporting the contrast as calculated in
14.1, or whether the medical device is equivalent in contrast
(optical density) to the comparison standard (14.2), or the
percent relative linear attenuation coefficient (14.3).

12. ProcedureMethod B
12.1 Expose the test specimen, with the comparison standard alongside it, to the X ray, in accordance with the
procedure described in 11.1-11.3, inclusive.
12.2 Measurement Compare the images of the medical
device with the comparison standard on the developed film as
to optical density.
13. ProcedureMethod C
13.1 Expose the test specimen (9.4), with the comparison
standard (7.2) alongside it, to the X ray, in accordance with the
procedure described in 11.1-11.3 inclusive.
13.2 Measurement Measure the optical density of the
images of the test specimen (plastic slab) and the comparison
standard, as well as the optical density of the background under
the 10-mm thickness of aluminum.

16. Precision and Bias

16.1 The precision and bias of these test methods have not
yet been established.
16.2 It is intended to develop data for the overall method
and the measurement of density from a round-robin test.

14. Calculation
14.1 Method AFrom the value of the optical density of the
background (11.4.1), subtract the optical density value of the
test specimen (11.4.2). Compare this difference, contrast
(3.2.2), to the required contrast specified in the standard for the
medical device.
14.2 Method BGiven that the background optical density
is in the correct range (0.8 to 1.2), note whether the optical

17. Keywords
17.1 implants; plastic surgical devices; polymers; surgical
applications; radiopacity; test methods; surgical implants

F 640
APPENDIXES
(Nonmandatory Information)
X1. VARIABLES IN RADIOPACITY OF PLASTICS IN MEDICAL DEVICES

X1.1 GeneralThe initial development of this standard

was based on the need to determine the location in the body of
plastic parts of small diameter. This led to a proposed requirement for an optical density contrast measured on the medical
device. However, radiopacity is a property of many types of
medical devices and its required numerical level is influenced
by many variables, some of the principal being: type of plastic;
size, thickness, and configuration; part of body or circulatory
system; and X-ray energy applied in the procedure.

there be a preferred test method (of the three described). It is

expected that a standard specification for the medical device
will specify the required level of radiopacity, as determined by
a particular test method (A, B, or C). The standard specification
for the medical devices may also specify values for some
parameters of the test method, such as: thickness of aluminum
on top of the test specimen, whether 10 mm, 15 mm, or other;
X-ray test voltage; and dimensions and composition of the
comparison standard (Method B).

X1.2 Specification ValuesThis standard does not have

any requirements for minimum levels of radiopacity, nor that

X2. COMPARISON OF THE THREE TEST METHODS

X2.1 Method AIt has been proposed that, for many

applications, an optical density contrast of 0.10 is satisfactory.
For larger pieces and thin sections of the human body, a
contrast of 0.05 optical density units may be adequate.

X2.3.2 This test method may be necessary where it is

difficult to characterize the radiopacity of the medical device,
because of either its size or configuration. The remedy is to
require a minimum radiopacity in the plastics formulation.
X2.3.3 From available reports on the development of medical devices, such as interuterine devices (IUDs) and from
comments made by Committee F-4 members, it is obvious that
radiopaque formulations are often measured by Method C. It
has usually been done by comparing materials. Due to the
variations in background optical density, it appears that a more
reliable comparison and more reproducible test data can result
if No. 1100 aluminum or other material with well-known X-ray
absorption is used as a standard of radiopacity.

X2.2 Method BThis test method has been considered to

assure the radiopacity of a medical device. The dimension of
the comparison standard, especially thickness in the direction
of the X-ray path, does not have to correspond to the
dimensions of the medical device.
X2.3 Method C:
X2.3.1 This test method is now being specified in Practice
F 647.

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