ASTM F3495-23
(Test Method)Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
SIGNIFICANCE AND USE
5.1 These test methods are intended to determine the ultimate failure load of a ceramic femoral knee component. This information can be used for evaluation of different ceramic component designs or different ceramic materials, or for series production control.
5.2 Although the test methodology described attempts to identify physiologically relevant intraoperative and in vivo loading conditions, the interpretation of results is limited to an in vitro comparison between ceramic femoral component designs and materials regarding their static ultimate failure load under the stated test conditions.
SCOPE
1.1 The test methods included in this standard cover two procedures for static burst testing of a ceramic femoral component used in total knee replacement (TKR). The two procedures are used to determine the static ultimate failure load of a ceramic femoral knee component. Both procedures are simulating in vivo loading conditions. One of the procedures additionally simulates intraoperative loading conditions. The standard applies to cruciate retaining (CR) femoral components which cover both the medial and lateral condyles and the patellar surface of the femur. These test methods may require modifications to accommodate other femoral component designs.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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.
1.4 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
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: F3495 − 23
Standard Test Methods for
Determining the Static Failure Load of Ceramic Knee
1
Femoral Components
This standard is issued under the fixed designation F3495; 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 F3161 Test Method for Finite Element Analysis (FEA) of
Metallic Orthopaedic Total Knee Femoral Components
1.1 The test methods included in this standard cover two
under Closing Conditions
procedures for static burst testing of a ceramic femoral
F3210 Test Method for Fatigue Testing of Total Knee
component used in total knee replacement (TKR). The two
Femoral Components Under Closing Conditions
procedures are used to determine the static ultimate failure load
2.2 Other Standards:
of a ceramic femoral knee component. Both procedures are
ISO 14704 Fine ceramics (advanced ceramics, advanced
simulating in vivo loading conditions. One of the procedures
technical ceramics)—Test method for flexural strength of
additionally simulates intraoperative loading conditions. The
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monolithic ceramics at room temperature
standard applies to cruciate retaining (CR) femoral components
which cover both the medial and lateral condyles and the
3. Terminology
patellar surface of the femur. These test methods may require
3.1 Definitions—The definitions and terms of Specification
modifications to accommodate other femoral component de-
F2083 apply.
signs.
3.2 Definitions of Terms Specific to This Standard:
1.2 The values stated in SI units are to be regarded as
3.2.1 component size—size of femoral component as given
standard. No other units of measurement are included in this
by the manufacturer.
standard.
3.2.2 compression force—used for the compression load test
1.3 This standard does not purport to address all of the
and is referred to as F.
safety concerns, if any, associated with its use. It is the
3.2.3 corner—angular design feature of the inner contour of
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter- a femoral component; to be seen in the sagittal view; see Fig.
mine the applicability of regulatory limitations prior to use. 1 for details.
1.4 This international standard was developed in accor-
3.2.4 counter force—used for the tension load test, is acting
dance with internationally recognized principles on standard-
along the force axis and is referred to as F .
2
ization established in the Decision on Principles for the
3.2.5 distal face—the distal face is part of the inner contour
Development of International Standards, Guides and Recom-
of the component. The distal face is touching the femoral bone
mendations issued by the World Trade Organization Technical
at the transverse resection plane. Typically the pegs are part of
Barriers to Trade (TBT) Committee.
the distal face; see Fig. 2 for details.
3.2.6 force axis—line of action of the tensile force F and
2. Referenced Documents
1
2 the counter force F applied to the femoral component.
2
2.1 ASTM Standards:
3.2.7 lower unit—bearing frame attached to the test machine
C1161 Test Method for Flexural Strength of Advanced
to apply the counter force.
Ceramics at Ambient Temperature
F2083 Specification for Knee Replacement Prosthesis
3.2.8 stroke rate—the rate of the stroke displacement of the
force applicator.
1 3.2.9 tensile force—used for the tension load test, is acting
These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and are the direct responsibility of
along the force axis and is referred to as F .
1
Subcommittee F04.22 on Arthroplasty.
3.2.10 upper unit—bearing frame attached to test machine
Current edition approved July 15, 2023. Published August 2023. DOI: 10.1520/
F3495-23. to apply the tensile force.
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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
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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.
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F3495 − 23
4.3 The compression load test method provides a means to
measure the ultimate failure
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