ASTM F2025-06(2018)
(Practice)Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
SIGNIFICANCE AND USE
3.1 This practice uses a weight-loss method of wear determination for the polymeric components or materials used in human joint prostheses, using serum or demonstrated equivalent fluid for lubrication, and running under a load profile representative of the appropriate human joint application (1,2) .4 The basis for this weight-loss method for wear measurement was originally developed (3) for pin-on-disk wear studies (Practice F732) and has been extended to total hip replacements (4, 5, ISO 14242–2, and Guide F1714), and to femoro-tibial knee prostheses (6 and ISO 14243–2), and to femoro-patellar knee prostheses (6,7).
3.2 While wear results in a change in the physical dimensions of the specimen, it is distinct from dimensional changes due to creep or plastic deformation, in that wear results in the removal of material in the form of polymeric debris particles, causing a loss in weight of the specimen.
3.3 This practice for measuring wear of the polymeric component is suitable for various simulator devices. These techniques can be used with metal, ceramic, carbon, polymeric, and composite counter faces bearing against a polymeric material (for example, polyethylene, polyacetal, and so forth). Thus, this weight-loss method has universal application for wear studies of human joint replacements which feature polymeric bearings. This weight-loss method has not been validated for non-polymeric material bearing systems, such as metal-metal, carbon-carbon, or ceramic-ceramic. Progressive wear of such rigid bearing combinations has generally been monitored using linear, variable-displacement transducers, or by other profilometric techniques.
SCOPE
1.1 This practice describes a laboratory method using a weight-loss (that is, mass-loss; see X1.4) technique for evaluating the wear properties of polymeric materials or devices which are being considered for use as bearing surfaces of human joint replacement prostheses. The test specimens are evaluated in a device intended to simulate the tribological conditions encountered in the human joint; for example, use of a fluid such as bovine serum, or equivalent pseudosynovial fluid shown to simulate similar wear mechanisms and debris generation found in vivo.
1.2 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.
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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: F2025 − 06 (Reapproved 2018)
Standard Practice for
Gravimetric Measurement of Polymeric Components for
1
Wear Assessment
This standard is issued under the fixed designation F2025; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ISO14243–2Implants for Surgery—Wear of Total Knee-
Joint Prostheses—Part 2: Methods of Measurement
1.1 This practice describes a laboratory method using a
weight-loss (that is, mass-loss; see X1.4) technique for evalu-
3. Significance and Use
ating the wear properties of polymeric materials or devices
3.1 This practice uses a weight-loss method of wear deter-
which are being considered for use as bearing surfaces of
mination for the polymeric components or materials used in
human joint replacement prostheses. The test specimens are
human joint prostheses, using serum or demonstrated equiva-
evaluated in a device intended to simulate the tribological
lent fluid for lubrication, and running under a load profile
conditionsencounteredinthehumanjoint;forexample,useof
representative of the appropriate human joint application
a fluid such as bovine serum, or equivalent pseudosynovial
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(1,2). The basis for this weight-loss method for wear mea-
fluid shown to simulate similar wear mechanisms and debris
surement was originally developed (3) for pin-on-disk wear
generation found in vivo.
studies (Practice F732) and has been extended to total hip
1.2 This international standard was developed in accor-
replacements (4, 5, ISO14242–2, and Guide F1714), and to
dance with internationally recognized principles on standard-
femoro-tibial knee prostheses (6 and ISO14243–2), and to
ization established in the Decision on Principles for the
femoro-patellar knee prostheses (6,7).
Development of International Standards, Guides and Recom-
3.2 While wear results in a change in the physical dimen-
mendations issued by the World Trade Organization Technical
sions of the specimen, it is distinct from dimensional changes
Barriers to Trade (TBT) Committee.
due to creep or plastic deformation, in that wear results in the
2. Referenced Documents removal of material in the form of polymeric debris particles,
2
causing a loss in weight of the specimen.
2.1 ASTM Standards:
D792Test Methods for Density and Specific Gravity (Rela- 3.3 This practice for measuring wear of the polymeric
tive Density) of Plastics by Displacement component is suitable for various simulator devices. These
D1505Test Method for Density of Plastics by the Density- techniquescanbeusedwithmetal,ceramic,carbon,polymeric,
Gradient Technique and composite counter faces bearing against a polymeric
F732Test Method for Wear Testing of Polymeric Materials material (for example, polyethylene, polyacetal, and so forth).
Used in Total Joint Prostheses Thus, this weight-loss method has universal application for
F1714GuideforGravimetricWearAssessmentofProsthetic wear studies of human joint replacements which feature
Hip Designs in Simulator Devices polymeric bearings. This weight-loss method has not been
3
2.2 Other Standards: validated for non-polymeric material bearing systems, such as
metal-metal, carbon-carbon, or ceramic-ceramic. Progressive
ISO14242–2ImplantsforSurgery—WearofTotalHip-Joint
Prostheses—Part 2: Methods of Measurement wear of such rigid bearing combinations has generally been
monitored using linear, variable-displacement transducers, or
by other profilometric techniques.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
4. Components and Materials
F04.22 on Arthroplasty.
Current edition approved April 1, 2018. Published May 2018. Originally
4.1 Hip Prosthesis Components—The hip joint prosthesis
approved in 2000. Last previous edition approved in 2012 as F2025–06 (2012).
comprises a ball-and-socket configuration in which materials
DOI: 10.1520/F2025-06R18.
2 such as polymers, composites, metal alloys, ceramics, and
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 carbon have been used in various combinations and designs.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
4th Floor, New
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