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: F2345 − 21

Standard Test Methods for

Determination of Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads1
This standard is issued under the fixed designation F2345; 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 2.2 Other Documents:

DIN 4768 Determination of Surface Roughness Ra, Rz, and
1.1 These test methods cover the evaluation of the cyclic
Rmax with Electric Stylus Instruments; Basic Data3
fatigue strength of ceramic modular femoral heads, mounted ISO 6474-1 Implants for surgery—Ceramic materials—Part
on a cone as used on the femoral stem of the total hip 1: Ceramic materials based on high purity alumina4
arthroplasty. ISO 6474-2 Implants for surgery—Ceramic materials—Part
1.2 These test methods were primarily developed for evalu- 2: Composite materials based on a high-purity alumina
ation of ceramic (Specification F603, ISO 6474-1, ISO 6474-2, matrix with zirconia reinforcement4
ISO 13356) head designs on metal cones but may have ISO 7206-10 Implants for surgery—Partial and total hip-
application to other materials. joint prostheses—Part 10: Determination of resistance to
static load of modular femoral head4
1.3 The values stated in SI units are to be regarded as ISO 13356 Implants for surgery—Ceramic materials based
standard. No other units of measurement are included in this on yttria-stabilized tetragonal zirconia (Y-TZP)4
standard.
1.4 This standard does not purport to address all of the 3. Terminology
safety concerns, if any, associated with its use. It is the 3.1 Definitions of Terms Specific to This Standard:
responsibility of the user of this standard to establish appro- 3.1.1 bore—conical blind hole in the surface of the modular
priate safety, health, and environmental practices and deter- femoral head.
mine the applicability of regulatory limitations prior to use. 3.1.2 bore angle—included angle of the conical surface of
1.5 This international standard was developed in accor- the bore (Fig. 1).
dance with internationally recognized principles on standard- 3.1.3 circularity—deviations of taper cross section from a
ization established in the Decision on Principles for the perfect circle.
Development of International Standards, Guides and Recom- 3.1.4 cone—metal truncated right-circular cone (male com-
mendations issued by the World Trade Organization Technical ponent) used to engage with a mating conical bore (female
Barriers to Trade (TBT) Committee. component) of the modular femoral head.
3.1.5 cone angle—included angle of the conical surface of
2. Referenced Documents
the cone (Fig. 2).
2.1 ASTM Standards:2 3.1.6 femoral neck-axis—centerline or axis of symmetry of
E4 Practices for Force Verification of Testing Machines the femoral cone.
F603 Specification for High-Purity Dense Aluminum Oxide
3.1.7 head size—nominal spherical diameter of the head
for Medical Application
(generally standardized, but not limited to 22, 26, 28, 32, 36,
40, and 44 mm for total hips.)
3.1.8 installation load—the force, applied at 0° from the
1
These test methods are under the jurisdiction of ASTM Committee F04 on femoral neck-axis and used to connect the head and neck
Medical and Surgical Materials and Devices and are the direct responsibility of
Subcommittee F04.22 on Arthroplasty. components prior to testing.
Current edition approved May 1, 2021. Published June 2021. Originally
approved in 2003. Last previous edition approved in 2013 as F2345 – 03 (2013).
DOI: 10.1520/F2345-21.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Beuth Verlag GmbH (DIN—DIN Deutsches Institut fur
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM Normung e.V.), Burggrafenstrasse 6, 10787, Berlin, Germany.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.

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

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 F2345 − 21

FIG. 1 Geometrical Design Criteria for Modular Head

FIG. 3 Loading in a Metal Cone

FIG. 2 Geometrical Design Criteria for Mating Conical Fit

3.1.9 load axis—line of action of the compressive force

applied to the femoral head.
3.1.10 load axis angle—the measured angle “L” between
the line of action of the applied force and femoral neck axis
(see Fig. 5).
3.1.11 load magnitude—the peak (absolute value) compres-
sive force of the applied constant amplitude cyclic force.
3.1.12 load rate—rate of applied compressive force.
3.1.13 stroke rate—nominal rate of movement of the mov-
ing component of the test machine.
3.1.14 surface finish—measured roughness of the surface of
the taper cone or head bore as determined by DIN 4768.
3.1.15 test frequency—the rate of cyclic repetition of fatigue
FIG. 4 Loading Through a Copper Ring
loading in cycles per second.
3.1.16 THR—total hip replacement.
4. Significance and Use and other conditions on the cyclic load-carrying ability of
4.1 These test methods can be used to determine the effects modular femoral heads mounted on the cones of femoral stem
of head and cone materials, design variables, manufacturing, prostheses.

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 F2345 − 21
capacity (up to 50 kN). The test equipment should meet the
requirements outlined in Practices E4.
6.2 The varying force, as determined by suitable dynamic
verification, should be maintained at all times to be within
62 % of the largest compressive force being used for the
duration of the test.

7. Procedure
7.1 Sample Characterization:
7.1.1 Femoral heads and cones shall be characterized by the
manufacturer and shall fulfill the manufacturer’s requirements
of actual implants, according to 6.1 and 6.3 of ISO 7206-10.
7.2 Sample Assembly:
7.2.1 Following normal laboratory cleaning procedures to
remove any debris or other surface contaminants, the head and
cone are assembled on a suitable test machine. A suggested
procedure for cleaning and drying of the specimens is given in
FIG. 5 Pictorial Example of the Load Angle “L” Appendix X1. Any cleaning procedures used should be con-
sistent with typical manufacturing practices.
4.2 The loading of modular femoral heads in vivo will, in 7.2.2 Follow the assembly procedure according to 7.2 of
general, differ from the loading defined in these methods. The ISO 7206-10.
results obtained here cannot be used to directly predict in-vivo 7.3 General Test Requirements:
performance. However, these methods are designed to allow 7.3.1 The tests are performed at 37 °C in physiological
for comparisons between the fatigue performance of different solution (for example, Ringer’s solution). The tests can be
ceramic modular femoral head designs, when tested under performed at room temperature, if it is shown that such
similar conditions. temperature change does not influence the test results signifi-
4.3 These test methods may use actual femoral prostheses or cantly. Several weeks of soaking components made from
neck-cone models of simplified geometry with the same inorganic materials like metal alloys or ceramics in physiologi-
geometrical and material characteristics as in the implants. In cal solution is not necessary.
either case, the matching metallic cone region of the test 7.3.2 New test cones and femoral heads shall be used for
specimen selected shall be of the same material, tolerances, and each test. Note that it is imperative that components that
finish as the final femoral stem prosthesis. survive the test should not be used for clinical purposes after
testing.
4.4 In the fatigue test methods, it is recognized that actual
7.3.3 The load axis angle “L” shall be maintained within
loading in vivo is quite varied, and that no one set of
61° for all test samples.
experimental conditions can encompass all possible variations.
Thus, the test methods included here represent a simplified NOTE 1—Precautions should be taken to protect the test operator from
model for the purposes of comparisons between designs and injury by fragments should the specimen shatter when under load or when
materials. These test methods are intended to be performed in disassembling or when storing the specimen after removal of the force
from unfractured specimens.
physiological solution.
7.4 On-Axis Fatigue Test Method:
4.5 The test data may yield valuable information about the
relative strengths of different head and cone designs. 7.4.1 The maximum test frequency shall not exceed 30 Hz.
7.4.2 The load axis angle “L” is 0 6 1°.
5. Apparatus 7.4.3 Number of Test Specimens—A minimum of five speci-
5.1 The loading fixtures should be capable of sustaining mens is recommended for a test group.
static forces up to the anticipated fracture level. The fatigue 7.4.4 The femoral head may be loaded through a hardened
tests should use fixtures with fatigue load capacity up to 50 kN. metal 100 6 1° cone (Fig. 3) or alternatively, the contact ring
may be protected by means of a copper ring (Fig. 4) in
5.2 The fixtures shall be constructed so that the line of force accordance with ISO 7206-10.
application passes through the center of the femoral head. 7.4.5 The conical metal loading fixture may be damaged if
5.3 Due to the high forces anticipated in this type of cyclic, the test fractures the sample. It should be examined after each
potentially destructive test, appropriate shielding of the modu- test fracture and be discarded if damaged. If a copper ring is
lar ball test site is recommended. used for the contact surface, a new ring should be used for each
test specimen.
6. Equipment Characteristics 7.4.6 The fatigue force shall have a sinusoidal waveform
6.1 The fatigue tests should generally be performed on applied from the force magnitude to a minimum that is 10 % of
hydraulic (servo-hydraulic) load frames with adequate load the load magnitude.

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 F2345 − 21
7.4.7 The cyclic forces should be applied until 10 million amplitude, and a description of the loading contact for each
cycles without failure of the components or until fracture has sample. The report shall also contain information about the
occurred. time interval between the fatigue test and the post-fatigue burst
7.5 Off-Axis Fatigue Test Method: test.
7.5.1 The maximum test frequency shall not exceed 30 Hz. 8.3 Test Results—The number of cycles completed by the
7.5.2 The load axis angle “L” is 30 6 1°. sample and whether the sample failed. A statement justifying
7.5.3 A polymeric spherical concave component with the the number and kinds of samples should be included.
same segment diameter 0.643 times the head diameter should 8.4 Additional optional information characterizing the bore
be used (Fig. 5). The segment diameter should not change and cone dimensions and tolerances (Figs. 1 and 2) would be
during the test. desirable to better interpret the test results. This information
7.5.4 The fatigue force shall have a sinusoidal waveform may include, but is not limited to the following: cone type,
applied from the force magnitude to a minimum that is 10 % of head bore angle, head bore major/minor diameters, bore
the load magnitude. surface roughness (Ra, Rz per DIN 4768), cone angle, cone
7.6 Post-Fatigue Burst Test Method: diameter, cone surface roughness (Ra, Rz per DIN 4768),
7.6.1 Following the on-axis fatigue test or off-axis fatigue length of mating interface between the bore and cone, and
test, respectively, a burst test according to ISO 7206-10 in air method of femoral ball sterilization.
and at ambient conditions shall be performed to determine the
static strength of the femoral heads remaining after the cyclic 9. Precision and Bias
fatigue loading. 9.1 Precision—It is not possible to have a precision state-
ment because there is not a standard implant available to all
NOTE 2—The post-fatigue burst test should be done within a reasonable
time interval (for example, one or two days) after the fatigue test loading users of the test method to develop such a statement.
has been completed. Additionally, it is not possible to specify the precision of the
procedure in this test method because of the wide variance in
8. Report design of the components to be tested.
8.1 The report shall identify the manufacturer(s), head size,
9.2 Bias—No statement can be made as to the bias of this
femoral head material, the definition of failure used in the test,
test method since no acceptable reference values are available.
the cone material, and the description of the cone and taper
geometries. 10. Keywords
8.2 The report shall also describe the test method, test 10.1 bore; ceramic; cone; fatigue; modular head; static;
frequency, the peak force, the load axis angle “L,” load strength

APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 Modular or interchangeable femoral heads have been X1.3.1 Complications such as fracture of the ceramic head
used in various THR designs since approximately 1970. This have been rare in over one million cases in Europe. Boutin (1)5
concept provides several features to suit the patient as planned reported two alumina ceramic heads and four cup fractures out
pre-operatively or selected intra-operatively by the surgeon, or of the first 373 cases performed from 1970 to 1973. The head
both, such as component material, neck length, or head fractures occurred with ceramic head/ceramic cup
diameter, or combinations thereof. combinations, but since 1972 there have been no other head
fracture cases (1). A survey of clinical literature (2) from 1974
X1.2 The alumina ceramic (Specification F603)-metal fric- to 1980 for modular alumina ceramic heads revealed 23
tion lock fit has been used for head diameters 32 mm and 28 ceramic head fractures in the eight clinical publications re-
mm in Europe from 1973 onwards and in Japan from 1977 ported.
onwards, respectively. Zirconia ceramic (ISO 13356)-metal
friction lock fit has been used for head diameters 32 mm, 28 X1.3.2 In Japan, there have been zero head fractures re-
mm, 26 mm, and 22 mm in Europe from 1985 onwards and in ported in the literature for 28 mm alumina ceramic heads (3).
the USA from 1989 onwards. In Canada, Cameron (4) reported three ball fractures in a series
of 600 cases. One occurred as a result of an autoclaving
X1.3 In general, the potential complications of modular incident, one was due to high-speed trauma, and one case
femoral heads could be as follows: fracture of the femoral
head; dislocation of head from cone; wear of cone due to 5
The boldface numbers in parentheses refer to the list of references at the end of
loosening/rotation of head; and fracture of cone. this standard.

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 F2345 − 21
revealed no obvious reason. Thus the fracture incidence in this laboratory test. The 2 kN static force is arbitrary.
appeared to be 1 in 600 cases or 0.16 % in this series. Although impact forces are usually used clinically to mount the
X1.3.3 There were additional problems with an early Euro- head, such forces vary widely based on surgeon preference and
pean design that involved epoxy fixation of a 32 mm alumina surgical site. In addition, providing repeatable impact forces in
modular femoral head to the femoral stem. Boutin (1) used this a laboratory is difficult and may be beyond the capability of
concept from April 1970 onwards and reported 28 heads out of many laboratories. The 2 kN force represents a lower boundary
his initial 123 clinical cases separated from the stems due to of the mounting forces that could be encountered clinically.
degradation of the epoxy. X1.7 The hard bearing utilized in the axial test method may
X1.3.4 There are very few reports of fractures of zirconia create a surface stress state in the head that deviates from the
heads. Hummer et al. (5) reported two cases of 28 mm zirconia state created with a polymeric bearing surface. Finite-Element-
head fractures of a total of 189 ceramic heads (1.05 % fracture Analysis (FEA) studies have confirmed this but indicate that
rate), without a clearly established origin, although in one case stresses in the critical areas, where fractures initiate, are
the patient fell. unaffected. Use of the hard bearing is necessary to accommo-
X1.3.5 A series of ten ruptures of zirconia heads were date the high forces attainable in axial tests. It is a compromise
reported by Arnaud et al. (6), all from the same 22 mm head between the desire to imitate representative loading conditions
design. This series of ruptures seems to be due to the and the limits of available engineering materials. The hard
inappropriate fit between the head and taper. The angle of the bearing method has been used by manufacturers and is
head bore was smaller than the angle of the metallic taper. generally accepted as a reasonable method to evaluate the
strength of ceramic femoral heads.
X1.3.6 A detailed survey for one zirconia head source was
published by Cales (7) concerning 280 000 implanted heads X1.8 Often static tests to fracture are performed after
between 1985 and 1994. Most of the observed fractures were fatigue testing. Users of these test methods should be aware
related to abnormal conditions of use, mainly trauma and that samples that have survived axial tests have been known to
implantation of zirconia heads on non-revised tapers. The total fracture catastrophically after removal from the test machine.
failure rate, based on the reported cases, is 0.01 %. Although rare, such fractures can occur at any time post-test.
Therefore, for safety reasons, it is recommended that post-
X1.4 A load axis angle “L” of 10 to 45° with a hip force in
fatigue test samples be handled carefully with shielding be-
the 2 to 3 kN range is generally considered physiological. At an
tween the end of the fatigue testing and the static test to
orientation of L = 0°, modular femoral heads may take up to 40
fracture. If the sample fractures during this transition, it should
to 250 kN force before failure occurs. Clearly forces of this
be reported. If the samples are not static tested to destruction,
magnitude are not possible at anatomic orientations, because
they should be disassembled or stored in closed containers.
the neck of the femoral stem will either bend or break.
However, the non-symmetrical loading of the modular head X1.9 Occasionally, during a static axial test, the fragments
can change the stress states in the modular head, which could of the head may be trapped within the fixturing and continue to
change the response of the modular head. Consequently, it may bear forces without significant indication of the moment of
be desirable to evaluate the fatigue strengths of some modular fracture. Careful monitoring of the test may be necessary to
head designs at anatomic forces in an off-axis orientation. identify such occurrences and correctly identify the static
X1.4.1 The 30° angle specified for “L” may not be intuitive strength.
for all users familiar with other standard “anatomic” test
orientations. 30° was preferred for this test as it is well within X1.10 The test frequency limit of 30 Hz is arbitrary and
the applicable physiological range of orientation and it permits based on the general experience of one laboratory. It was found
higher applied test forces without compromise of the implant that at frequencies higher than 30 Hz, it was more difficult to
neck. maintain a smooth, stable load waveform. In addition, some
older mechanical rotating eccentric test machines that might be
X1.5 These test methods are intended to evaluate the suitable for this test operate at a fixed 30 Hz frequency.
mechanical strength of the combination of material and design
in a modular ceramic head under single loads to fracture and X1.11 For new material containing zirconia, there have
fatigue loads in physiological solution. They are not intended been cases of changes in the long-term stability of the
to evaluate the sensitivity of the ceramic materials to a tetragonal phase that leads to a decrease in the mechanical
simulated physiological environment. If the material does not properties. It has been shown that two types of pretreatment
have a long-established clinical history, other methods will be followed by the fatigue test can demonstrate if this is a problem
required to evaluate such sensitivity. (8, 9). The first method is to steam autoclave for 5 h at 134 °C
and two bars of pressure. The second method is exposure to
X1.6 For repeatability and reproducibility, a 2 kN static boiling water for 15 h. Either of these is purported to represent
installation force is used to seat the balls on their tapered seat approximately ten years of in-vivo exposure.

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 F2345 − 21

X2. METHOD FOR CLEANING OF SPECIMENS

X2.1 Rinse with tap water to remove bulk contaminants. X2.4 Rinse in an ultrasonic cleaner in distilled water for 5
min.
X2.2 Wash in an ultrasonic cleaner in a solution of 1 %
detergent for 15 min. X2.5 Rinse in a stream of distilled water.
X2.3 Rinse in a stream of distilled water. X2.6 Allow to air dry.

REFERENCES

(1) Boutin, P., “L’Alumine et Son Utilitsation en Chirurgie de la Hanche Failure of Modular Zirconia-Ceramic Femoral Head Components
(Elude Experimentale),” La Presse Medicale, Vol 79, No. 14, 1971, After Total Hip Arthroplasty,” J. Arthoplasty, Vol 10, 1995, pp.
pp. 539–641. 848–850.
(2) Plitz, W., and Griss, P., “Clinical, Histo-morphological and Material (6) Arnaud, J. M., Charissoux, J. L., Setton, D., Pecout, C., Mechin, J. F.,
Related Observations on Removed Alumina Ceramic Hip Joint Dunoyer, J., “Utilisation de la zircone pour les têtes 22,2 de PTH. A
Components,” Implant Retrieval: Material and Biological Analysis, propos de 10 fractures de tête,” Presented at 30th meeting of Société
edited by A. Weinstein, D. Gibbons, S. Brown, and W. Ruff, Orthopédique de l’Quest, Pont-l’ Abbé, France, June 1997.
Transactions, Proceedings of a Conference Held at the National (7) Cales, B., “Fracture Ratio of Zirconia Hip Joint Heads Compared to
Bureau of Standards, Gaithersburg, May 1–3, 1981, pp. 132–156. Other Ceramic Bearing Systems,” SICOT 99, Sidney, 1999, p. 599.
(3) Oonishi, H., and Takayama, Y., “Comparison of Wear of U.H.M.W.
(8) Wise, D. L., Cambridge Scientific, Inc., Belmont, Massachusetts,
Polyethylene Sliding Against Metal and Alumina in Total Hip
“Biomaterials and Bioengineering Handbook,” Marcel Dekker, Inc.,
Prostheses—Wear Test and Clinical Results,” Transactions, The Third
2000.
World Biomaterials Congress, Kyoto, Japan, April 21–25, 1988, p.
337. (9) Chevalier, J., Drouin, J. M., Cales, B., Norton Desmarquest Fine
(4) Cameron, H., Letter to the Editor, J. Arthroplasty, Vol 6, 1991, pp. Ceramics, Evreux Cedex, France, “Low Temperature Aging Behavior
185–188. of Zirconia Hip Joint Heads,” 10th International Symposium on
(5) Hummer, C. D., Rothmann, R. H., Hozack, W. J., “Catactrophic Ceramics in Medicine, Paris, France, October 1997.

BIBLIOGRAPHY

(1) Paul, J. P., and McGrouther, D. A., “Forces Transmitted at the Hip (6) Hinterberger , J., and Ungethum, M., “Investigations on Tribology
and Knee Joint of Normal and Disabled Persons During a Range of and Strength of Aluminum-Oxide-Ceramic-Hip Endoprostheses,” Z.
Activities,” Acta Orthopaedica, Vol 41, No. 1, Belgica, Tome, 1975, Orthop., Vol 116, 1978, pp. 294–303.
pp. 78–88. (7) Piconi, C., Labanti, M., Magnani, G., et al., “Analysis of Failed
(2) Dorre, E., and Hubner, H., “Medical Applications,” Alumina Pro- Alumina THR Ball Head,” Biomaterials, Vol 20, 1999, pp.
cessing Properties and Applications, Springer-Verlag, New York, 1637–1646.
1984, pp. 265–275. (8) Piconi, C., and Maccauro, G., “Zirconia as a Ceramic Biomaterial,”
(3) Wordsworth, R. A., and Weightman, B., “Laboratory Development Biomaterials, Vol 20, 1999, pp. 1–25.
of a Method of Attaching Ceramic Femoral Heads to Metal Stems,” (9) Heros, R. J., Willmann, G., “Ceramics in Total Hip Arthroplasty:
Biomaterials, Vol 7, 1986, pp. 83–88.
History, Mechanical Properties, Clinical Results, and Current Manu-
(4) Clarke, I. C., Jung, H., Chung, S., and Serbousek, J., “Mechanical
facturing State of the Art,” Seminars in Arthroplasty, Vol 9, 1998, p.
Evaluation of 28 mm Ceramic THR Balls,“Bioceramics Vol. 1,
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edited by H. Oonishi, H. Aoki, and K. Sawai, Ishiyaku EuroAmerica,
Inc., St. Louis, 1989, pp. 241–246. (10) FDA Guidance Document for the Preparation of Premarket Notifi-
(5) Crowninshield, R. D., Johnston, R. C., Andrews, J. G., and Brand, R. cations for Ceramic Ball Hip Systems (draft January 10, 1995),
A., “A Biomechanical Investigation of the Human Hip,” Journal Online, Available: www.fda.gov, 10 March 2020.
Biomechanics, Vol 11, 1978, pp. 75–85.

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 F2345 − 21
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