ASTM F732-17
(Test Method)Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
SIGNIFICANCE AND USE
4.1 This test method is intended to be performed in conjunction with pin-on-flat wear machines or similar machines that are designed to evaluate simplified specimen geometries.
Note 1: See Haider & Baykal (1)3 for useful considerations and potential pitfalls in conducting pin on disk testing, interpreting test results and the complex and sometimes conflicting effects of lower stress and higher contact area on wear.
4.2 This test method is designed to evaluate combinations of materials with respect to the amount of polymer wear, where quantifiable wear occurs primarily on the polymeric component. With some combinations of materials, significant wear of the counterface may occur, with subsequent embedding of counterface debris particles in the polymer. Such an occurrence will render the weight loss of the polymer specimen unreliable as an indicator of the polymer wear.
4.3 Wear is reported as volume loss of the polymeric specimen as a function of sliding distance; however, if the sliding distance is not constant across the polymeric specimen surface due to complex motion patterns, wear may be reported as volume loss of the polymeric specimen as a function of wear cycles (in which case a “wear cycle” shall be defined). Volume loss of the polymer specimen is determined by dividing the experimental weight loss by the density of the polymer. For ease of interpretation, wear should be reported as a function of both the number of wear cycles and the sliding distance, when possible.
4.4 The reference for the comparative evaluation of candidate materials shall be the wear rate of ultra-high-molecular-weight polyethylene (UHMWPE) conforming to Specification F648 bearing against counterfaces of cobalt-chromium-molybdenum alloy (in accordance with Specifications F75, F799, or F1537), having prosthetic-quality surface finish and lubricated with bovine blood serum (see 5.2).
SCOPE
1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup (“hip-type”) wear, delamination wear, and so forth). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material.
1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests.
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Developmen...
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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: F732 − 17
Standard Test Method for
Wear Testing of Polymeric Materials Used in Total Joint
1
Prostheses
ThisstandardisissuedunderthefixeddesignationF732;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This test method describes a laboratory method for
mendations issued by the World Trade Organization Technical
evaluating the wear properties of combinations of materials
Barriers to Trade (TBT) Committee.
that are being considered for use as bearing surfaces of human
total joint prostheses. The body of this test method contains
2. Referenced Documents
general methods which apply to all types of prosthesis wear
2
2.1 ASTM Standards:
applications while individual annexes describe specific wear
D883Terminology Relating to Plastics
test methods and clinical validation criteria tailored to each
F75Specification for Cobalt-28 Chromium-6 Molybdenum
distinct wear application (for example, linear reciprocating
Alloy Castings and Casting Alloy for Surgical Implants
motion, ball-cup (“hip-type”) wear, delamination wear, and so
(UNS R30075)
forth). It is the intent of this test method to rank materials,
F86Practice for Surface Preparation and Marking of Metal-
within each wear application, for polymer wear rates under
lic Surgical Implants
simulated physiological conditions. It must be recognized,
F648Specification for Ultra-High-Molecular-Weight Poly-
however, that contact geometries and wear motions are sim-
ethylene Powder and Fabricated Form for Surgical Im-
plified using such methods. This test method, therefore, repre-
plants
sents only an initial stage in the full wear characterization of a
F799Specification for Cobalt-28Chromium-6Molybdenum
candidate material.
Alloy Forgings for Surgical Implants (UNS R31537,
1.2 All candidate materials should be tested in an appropri-
R31538, R31539)
ate joint simulator apparatus using prototype prostheses before
F1537 Specification for Wrought Cobalt-28Chromium-
being used in clinical trials in patients. The tests described in
6Molybdenum Alloys for Surgical Implants (UNS
thistestmethodareusedtoquicklyandreliablyscreenmaterial
R31537, UNS R31538, and UNS R31539)
combinations for wear performance in different orthopaedic
F2025Practice for Gravimetric Measurement of Polymeric
wear applications prior to committing them to more expensive
Components for Wear Assessment
and time-consuming joint simulator testing. In addition, these
G40Terminology Relating to Wear and Erosion
simplifiedtestscanbeusedtorelatematerial,surfacefinish,or
other parameters to wear behavior on a more practical basis
3. Terminology
than is possible in joint simulator tests.
3.1 Definitions of Terms Specific to This Standard:
1.3 The values stated in either SI units or inch-pound units
3.1.1 wear—forthepurposeofthistestmethod,theprogres-
are to be regarded separately as standard. The values stated in
sive loss of material from the polymer specimen as a result of
each system may not be exact equivalents; therefore, each
theoscillatingmotionagainstthecounterfaceunderload.Wear
system shall be used independently of the other. Combining
may be generated by several mechanisms including adhesion,
values from the two systems may result in non-conformance
twoorthreebodyabrasion,surfacefatigue,orotherprocesses.
with the standard.
3.1.2 wearrate—thevolumeofmateriallostduetowearper
1.4 This international standard was developed in accor-
unit of sliding distance (or per million wear cycles if complex
dance with internationally recognized principles on standard-
motion patterns result in a non-uniform sliding distance across
the specimen; see 4.3).
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
2
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2017. Published October 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1982. Last previous edition approved in 2011 as F732–00 (2011). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F0732-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
-----------------
...
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: F732 − 00 (Reapproved 2011) F732 − 17
Standard Test Method for
Wear Testing of Polymeric Materials Used in Total Joint
1
Prostheses
This standard is issued under the fixed designation F732; 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 describes a laboratory method for evaluating the wear properties of combinations of materials that are
being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods
which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical
validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup (“hip-type”) wear,
delamination wear, etc.). and so forth). It is the intent of this test method to rank materials, within each wear application, for
polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear
motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear
characterization of a candidate material.
1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being
used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material
combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and
time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other
parameters to wear behavior on a more practical basis than is possible in joint simulator tests.
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D883 Terminology Relating to Plastics
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F2025 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
G40 Terminology Relating to Wear and Erosion
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved June 1, 2011Sept. 1, 2017. Published July 2011October 2017. Originally approved in 1982. Last previous edition approved in 20062011 as
F732 – 00 (2006).(2011). DOI: 10.1520/F0732-00R11.10.1520/F0732-17.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F732 − 17
3.1.1 wear—for the purpose of this test method, the progressive loss of material from the polymer specimen as a result of the
oscillating motion against the c
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