ASTM F2580-13
(Practice)Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
SIGNIFICANCE AND USE
4.1 This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic femoral hip prostheses subject to cyclic loading for large numbers of cycles.
4.2 The loading of femoral hip designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic femoral hip designs, when tested under similar conditions.
4.3 In order for fatigue data on femoral hip prostheses to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem.
1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F2580 − 13
Standard Practice for
Evaluation of Modular Connection of Proximally Fixed
1
Femoral Hip Prosthesis
This standard is issued under the fixed designation F2580; 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 E1150 Definitions of Terms Relating to Fatigue (Withdrawn
3
1996)
1.1 This practice covers a procedure for the fatigue testing
4
2.2 ISO Standards:
of metallic femoral hip prostheses used in hip joint replace-
ISO 7206–4 Determination of Endurance Properties of
ments.This practice covers the procedures for the performance
Stemmed Femoral Components with Application of Tor-
of fatigue tests on metallic femoral hip stems using a cyclic,
sion
constant-amplitude force. It applies to hip prostheses that
utilize proximal metaphyseal fixation and are of a modular
3. Terminology
construct,anditisintendedtoevaluatethefatigueperformance
of the modular connections in the metaphyseal filling (that is, 3.1 Definitions:
3.1.1 R value, n—The R value is the ratio of the minimum
proximal body) region of the stem.
load to the maximum load.
1.2 This practice is intended to provide useful, consistent,
minimum load
and reproducible information about the fatigue performance of
R 5
maximum load
metallic hip prostheses while held in a proximally fixated
manner, with the distal end not held by a potting medium. 3.2 Definitions of Terms Specific to This Standard:
3.2.1 extraction—removal of the femoral hip implant from
1.3 The values stated in SI units are to be regarded as
the femur during surgery.
standard. No other units of measurement are included in this
3.2.2 extractor hole—a hole in the proximal body of the
standard.
stem in which an apparatus is placed to remove the implant
1.4 This standard does not purport to address all of the
from the femur.
safety concerns, if any, associated with its use. It is the
3.2.3 femoral head—convex spherical bearing member for
responsibility of the user of this standard to establish appro-
articulation with the natural acetabulum or prosthetic acetabu-
priate safety and health practices and determine the applica-
lum.
bility of regulatory limitations prior to use.
3.2.4 femoral head offset—the perpendicular distance from
the centerline of the implant stem to the center of the femoral
2. Referenced Documents
head.
2
2.1 ASTM Standards:
3.2.5 frontal plane—the plane that lies in the medial-lateral
E467 Practice for Verification of Constant Amplitude Dy-
direction of the implant. Adduction occurs in this plane.
namic Forces in an Axial Fatigue Testing System
3.2.6 implant centerline—the axis that runs vertically from
E468 Practice for Presentation of Constant Amplitude Fa-
the proximal body of the implant, down the center of the stem
tigue Test Results for Metallic Materials
to the distal end.
3.2.7 pivot axis—the center of rotation of the pivot fixture
(andprosthesispottedwithinit)withinthetestfixturesetup;its
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
location is determined by the intersection of the neck and stem
Surgical Materials and Devices and is the direct responsibility of Subcommittee
centerlines of the prothesis (Figs. 1 and 2).
F04.22 on Arthroplasty.
Current edition approved Feb. 1, 2013. Published February 2013. Originally
approved in 2007. Last previous edition approved in 2009 as F2580 – 09. DOI:
10.1520/F2580-13.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.astm.org.
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 ----------------------
F2580 − 13
FIG. 1 Free Body Diagram of Test Setup
3.2.8 pivot fixture—the fixture in which the specimen is
potted, and is attached to the main test fixture; characterized by
two pins on the side that serve as the pivot axis.
3.2.9 rotational plane—the plane that lies perpendicular to
the stem axis of the implant.
3.2.10 sagittal plane—the plane that lies perpendicular to
the Frontal plane; flexion occurs in this plane.
4. Significance and Use
4.1 This practice can be used to describe the effects of
materials, manufacturing, and design variables on the fatigue
performance of metallic femoral
...
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: F2580 − 09 F2580 − 13
Standard Test Method Practice for
Evaluation of Modular Connection of Proximally Fixed
1
Femoral Hip Prosthesis
This standard is issued under the fixed designation F2580; 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 This test method covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements.
This test method covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic,
constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and
it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body)
region of the stem.
1.2 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of
metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium.
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E468 Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
3
E1150 Definitions of Terms Relating to Fatigue (Withdrawn 1996)
4
2.2 ISO Standards:
ISO 7206–4 Determination of Endurance Properties of Stemmed Femoral Components with Application of Torsion
3. Terminology
3.1 Definitions:
3.1.1 R value, n—The R value is the ratio of the minimum load to the maximum load.
minimum load
R 5
maximum load
3.2 Definitions of Terms Specific to This Standard:
3.2.1 extraction—removal of the femoral hip implant from the femur during surgery.
3.2.2 extractor hole—a hole in the proximal body of the stem in which an apparatus is placed to remove the implant from the
femur.
3.2.3 femoral head—convex spherical bearing member for articulation with the natural acetabulum or prosthetic acetabulum.
3.2.4 femoral head offset—the perpendicular distance from the centerline of the implant stem to the center of the femoral head.
1
This test method practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
Current edition approved Sept. 15, 2009Feb. 1, 2013. Published September 2009February 2013. Originally approved in 2007. Last previous edition approved in 20072009
as F2580 – 07.F2580 – 09. DOI: 10.1520/F2580-09.10.1520/F2580-13.
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.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from 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 ----------------------
F2580 − 13
3.2.5 frontal plane—the plane that lies in the medial-lateral direction of the implant. Adduction occurs in this plane.
3.2.6 implant centerline—the axis that runs vertically from the proximal body of the implant, down the center of the stem to
the distal end.
3.2.7 pivot axis—the center of rotation of the pivot fixture (and prosthesis potted within it) within the test fixture setup; its
location is determined by the intersection of the neck and stem centerlines of the prothesis (Figs. 1 and 2).
3.2.8 pivot fixture—the fixture in which the specimen is potted, and is attached to the main test fixture; characterized by two pins
on the side that serve as the pivot axis.
3.2.9 ro
...
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