ASTM F2345-21

Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

SIGNIFICANCE AND USE
4.1 These test methods can be used to determine the effects of head and cone materials, design variables, manufacturing, and other conditions on the cyclic load-carrying ability of modular femoral heads mounted on the cones of femoral stem prostheses.  
4.2 The loading of modular femoral heads in vivo will, in general, differ from the loading defined in these methods. The results obtained here cannot be used to directly predict in-vivo performance. However, these methods are designed to allow for comparisons between the fatigue performance of different ceramic modular femoral head designs, when tested under similar conditions.  
4.3 These test methods may use actual femoral prostheses or neck-cone models of simplified geometry with the same geometrical and material characteristics as in the implants. In either case, the matching metallic cone region of the test specimen selected shall be of the same material, tolerances, and finish as the final femoral stem prosthesis.  
4.4 In the fatigue test methods, it is recognized that actual loading in vivo is quite varied, and that no one set of experimental conditions can encompass all possible variations. Thus, the test methods included here represent a simplified model for the purposes of comparisons between designs and materials. These test methods are intended to be performed in physiological solution.  
4.5 The test data may yield valuable information about the relative strengths of different head and cone designs.
SCOPE
1.1 These test methods cover the evaluation of the cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.  
1.2 These test methods were primarily developed for evaluation of ceramic (Specification F603, ISO 6474-1, ISO 6474-2, ISO 13356) head designs on metal cones but may have application to other materials.  
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

• Status: Published
• Publication Date: 30-Apr-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Refers: ASTM F603-12(2020) - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• Effective Date: 01-Aug-2020

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: F2345 − 21
Standard Test Methods for
Determination of Cyclic Fatigue Strength of Ceramic
1
Modular Femoral Heads
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 R,R , and
a z
1.1 These test methods cover the evaluation of the cyclic
3
R with Electric Stylus Instruments; Basic Data
max
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 4
1: Ceramic materials based on high purity alumina
arthroplasty.
ISO 6474-2 Implants for surgery—Ceramic materials—Part
2: Composite materials based on a high-purity alumina
1.2 These test methods were primarily developed for evalu-
4
matrix with zirconia reinforcement
ation of ceramic (Specification F603, ISO 6474-1, ISO 6474-2,
ISO 7206-10 Implants for surgery—Partial and total hip-
ISO 13356) head designs on metal cones but may have
joint prostheses—Part 10: Determination of resistance to
application to other materials.
4
static load of modular femoral head
1.3 The values stated in SI units are to be regarded as
ISO 13356 Implants for surgery—Ceramic materials based
4
standard. No other units of measurement are included in this
on yttria-stabilized tetragonal zirconia (Y-TZP)
standard.
3. Terminology
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3.1 Definitions of Terms Specific to This Standard:
3.1.1 bore—conical blind hole in the surface of the modular
responsibility of the user of this standard to establish appro-
femoral head.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3.1.2 bore angle—included angle of the conical surface of
the bore (Fig. 1).
1.5 This international standard was developed in accor-
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
2.1 ASTM Standards:
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
components prior to testing.
Subcommittee F04.22 on Arthroplasty.
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 [e-mail]. 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 fromAmerican 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
1

---------------------- Page: 1 ----------------------
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 ang
...

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: F2345 − 03 (Reapproved 2013) F2345 − 21
Standard Test Methods for
Determination of Static and Cyclic Fatigue Strength of
1
Ceramic Modular Femoral Heads
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
1.1 These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads, mounted
on a cone as used on the femoral stem of the total hip arthroplasty.
1.2 These test methods were primarily developed for evaluation of ceramic (Specifications(Specification F603 and, ISO F1873)
6474-1, ISO 6474-2, ISO 13356) head designs on metal cones but may have application to other materials.
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:
E4 Practices for Force Verification of Testing Machines
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant
3
Applications (Withdrawn 2007)
F1875 Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
2.2 Other Documents:
3
DIN 4768 Determination of Surface Roughness R , R , and R with Electric Stylus Instruments; Basic Data
a z max
4
ISO 6474-1 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina
FDA Guidance DocumentISO 6474-2 for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems
1
ThisThese test method ismethods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and isare the direct responsibility
of Subcommittee F04.22 on Arthroplasty.
Current edition approved March 15, 2013May 1, 2021. Published April 2013June 2021. Originally approved in 2003. Last previous edition approved in 20082013 as
F2345 – 03 (2008).(2013). DOI: 10.1520/F2345-03R13.10.1520/F2345-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from Beuth Verlag GmbH (DIN—DIN Deutsches Institut fur Normung e.V.), Burggrafenstrasse 6, 10787, Berlin, Germany.
4
Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857.American National Standards Institute (ANSI), 25 W. 43rd St., 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
1

---------------------- Page: 1 ----------------------
F2345 − 21
(draftImplants for surgery—Ceramic materials—Part 2: Composite materials based on a high-purity alumina matrix Jan. 10,
4
1995)with zirconia reinforcement
ISO 7206-10 Implants for surgery—Partial and total hip-joint prostheses—Part 10: Determination of resistance to static load of
4
modular femoral head
4
ISO 13356 Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
3. Terminology
3.1 Definitions:Definitions of Terms Specific to This Standard:
3.1.1 bore—conical blind hole in the surface of the modular femoral head.
3.1.2 bore angle—included angle of the conical surface of the bore (Fig. 1).
3.1.3 circularity—deviations of taper cross section from a perfect circle.
3.1.4 cone—the proximal end of the femoral component fabricated as a truncated right cone and metal truncated right-circula
...