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ASTM F732-00(2011)

(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
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.
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.
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.
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, etc.). 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.

General Information

Status
Historical
Publication Date
31-May-2011
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F732-00(2006) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
01-Jun-2011
Replaced By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
01-Sep-2017
Referred By
ASTM G132-96(2018) - Standard Test Method for Pin Abrasion Testing
Effective Date
01-Jun-2011
Referred By
ASTM F3446-20 - Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
Effective Date
01-Jun-2011
Referred By
ASTM F1877-16 - Standard Practice for Characterization of Particles
Effective Date
01-Jun-2011
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Jun-2011
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
01-Jun-2011
Referred By
ASTM G115-10(2018) - Standard Guide for Measuring and Reporting Friction Coefficients
Effective Date
01-Jun-2011
Referred By
ASTM F2025-06(2018) - Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
Effective Date
01-Jun-2011
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Jun-2011
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Jun-2011
Referred By
ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
Effective Date
01-Jun-2011
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Jun-2011
Referred By
ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
Effective Date
01-Jun-2011

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ASTM F732-00(2011) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesASTM F732-00(2011) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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ASTM F732-00(2011) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F732 − 00 (Reapproved 2011)
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 2. Referenced Documents
2
1.1 This test method describes a laboratory method for
2.1 ASTM Standards:
evaluating the wear properties of combinations of materials
D883Terminology Relating to Plastics
that are being considered for use as bearing surfaces of human
F75Specification for Cobalt-28 Chromium-6 Molybdenum
total joint prostheses. The body of this test method contains
Alloy Castings and Casting Alloy for Surgical Implants
general methods which apply to all types of prosthesis wear
(UNS R30075)
applications while individual annexes describe specific wear
F86Practice for Surface Preparation and Marking of Metal-
test methods and clinical validation criteria tailored to each
lic Surgical Implants
distinct wear application (for example, linear reciprocating
F648Specification for Ultra-High-Molecular-Weight Poly-
motion,ball-cup(“hip-type”)wear,delaminationwear,etc.).It
ethylene Powder and Fabricated Form for Surgical Im-
is the intent of this test method to rank materials, within each
plants
wear application, for polymer wear rates under simulated
F799Specification for Cobalt-28Chromium-6Molybdenum
physiological conditions. It must be recognized, however, that
Alloy Forgings for Surgical Implants (UNS R31537,
contactgeometriesandwearmotionsaresimplifiedusingsuch
R31538, R31539)
methods.This test method, therefore, represents only an initial
F1537 Specification for Wrought Cobalt-28Chromium-
stage in the full wear characterization of a candidate material.
6Molybdenum Alloys for Surgical Implants (UNS
R31537, UNS R31538, and UNS R31539)
1.2 All candidate materials should be tested in an appropri-
F2025Practice for Gravimetric Measurement of Polymeric
ate joint simulator apparatus using prototype prostheses before
Components for Wear Assessment
being used in clinical trials in patients. The tests described in
G40Terminology Relating to Wear and Erosion
thistestmethodareusedtoquicklyandreliablyscreenmaterial
combinations for wear performance in different orthopaedic
3. Terminology
wear applications prior to committing them to more expensive
and time-consuming joint simulator testing. In addition, these
3.1 Definitions of Terms Specific to This Standard:
simplifiedtestscanbeusedtorelatematerial,surfacefinish,or
3.1.1 wear—forthepurposeofthistestmethod,theprogres-
other parameters to wear behavior on a more practical basis
sive loss of material from the polymer specimen as a result of
than is possible in joint simulator tests.
theoscillatingmotionagainstthecounterfaceunderload.Wear
1.3 The values stated in either SI units or inch-pound units
may be generated by several mechanisms including adhesion,
are to be regarded separately as standard. The values stated in
twoorthreebodyabrasion,surfacefatigue,orotherprocesses.
each system may not be exact equivalents; therefore, each
3.1.2 wear rate—thevolumeofmateriallostduetowearper
system shall be used independently of the other. Combining
unit of sliding distance (or per million wear cycles if complex
values from the two systems may result in non-conformance
motion patterns result in a non-uniform sliding distance across
with the standard.
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
CurrenteditionapprovedJune1,2011.PublishedJuly2011.Originallyapproved contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
in 1982. Last previous edition approved in 2006 as F732–00 (2006). DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0732-00R11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F732 − 00 (2011)
4. Significance and Use be filtered to remove hard, abrasive, particulate contaminants
that might otherwise affect the wear properties of the speci-
4.1 This test method is intended to be performed in con-
mens being tested.
junction with pin-on-flat wear machines or similar machines
5.2.3 Maintain the volume, concentration, and temperature
that are designed to evaluate simplified specimen geometries.
of the lubricant nearly constant throughout the te
...

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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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