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ASTM F732-00(2006)

(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 F 648 bearing against counterfaces of cobalt-chromium-molybdenum alloy (in accordance with Specifications F 75, F 799, or F 1537), 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.

General Information

Status
Historical
Publication Date
28-Feb-2006
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 - Standard Test Method for Wear Testing of Polymeric Materials for Use in Total Joint Prostheses
Effective Date
01-Mar-2006
Replaced By
ASTM F732-00(2011) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
01-Jun-2011
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Mar-2006
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Mar-2006
Referred By
ASTM G132-96(2018) - Standard Test Method for Pin Abrasion Testing
Effective Date
01-Mar-2006
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
01-Mar-2006
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Mar-2006
Referred By
ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
Effective Date
01-Mar-2006
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Mar-2006
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-Mar-2006
Referred By
ASTM G115-10(2018) - Standard Guide for Measuring and Reporting Friction Coefficients
Effective Date
01-Mar-2006
Referred By
ASTM F1877-16 - Standard Practice for Characterization of Particles
Effective Date
01-Mar-2006
Referred By
ASTM F2025-06(2018) - Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
Effective Date
01-Mar-2006
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-Mar-2006

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ASTM F732-00(2006) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesASTM F732-00(2006) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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ASTM F732-00(2006) - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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Standards Content (Sample)

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 2006)
Standard Test Method for
Wear Testing of Polymeric Materials Used in Total Joint
1
Prostheses
ThisstandardisissuedunderthefixeddesignationF732;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
1.1 This test method describes a laboratory method for
(UNS R30075)
evaluating the wear properties of combinations of materials
F86 Practice for Surface Preparation and Marking of Me-
that are being considered for use as bearing surfaces of human
tallic Surgical Implants
total joint prostheses. The body of this test method contains
F648 Specification for Ultra-High-Molecular-Weight Poly-
general methods which apply to all types of prosthesis wear
ethylene Powder and Fabricated Form for Surgical Im-
applications while individual annexes describe specific wear
plants
test methods and clinical validation criteria tailored to each
F799 Specification for Cobalt-28Chromium-6Molybdenum
distinct wear application (for example, linear reciprocating
Alloy Forgings for Surgical Implants (UNS R31537,
motion, ball-cup (“hip-type”) wear, delamination wear, etc.). It
R31538, R31539)
is the intent of this test method to rank materials, within each
F1537 Specification for Wrought Cobalt-28Chromium-
wear application, for polymer wear rates under simulated
6MolybdenumAlloysforSurgicalImplants(UNSR31537,
physiological conditions. It must be recognized, however, that
UNS R31538, and UNS R31539)
contact geometries and wear motions are simplified using such
F2025 Practice for Gravimetric Measurement of Polymeric
methods. This test method, therefore, represents only an initial
Components for Wear Assessment
stage in the full wear characterization of a candidate material.
G40 Terminology Relating to Wear and Erosion
1.2 All candidate materials should be tested in an appropri-
ate joint simulator apparatus using prototype prostheses before
3. Terminology
being used in clinical trials in patients. The tests described in
3.1 Definitions of Terms Specific to This Standard:
thistestmethodareusedtoquicklyandreliablyscreenmaterial
3.1.1 wear—for the purpose of this test method, the pro-
combinations for wear performance in different orthopaedic
gressive loss of material from the polymer specimen as a result
wear applications prior to committing them to more expensive
of the oscillating motion against the counterface under load.
and time-consuming joint simulator testing. In addition, these
Wear may be generated by several mechanisms including
simplified tests can be used to relate material, surface finish, or
adhesion, two or three body abrasion, surface fatigue, or other
other parameters to wear behavior on a more practical basis
processes.
than is possible in joint simulator tests.
3.1.2 wear rate—the volume of material lost due to wear
2. Referenced Documents per unit of sliding distance (or per million wear cycles if
2
complex motion patterns result in a non-uniform sliding
2.1 ASTM Standards:
distance across the specimen; see 4.3).
D883 Terminology Relating to Plastics
4. Significance and Use
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical 4.1 This test method is intended to be performed in con-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
junction with pin-on-flat wear machines or similar machines
F04.15 on Materials Test Methods.
that are designed to evaluate simplified specimen geometries.
Current edition approved March 1, 2006. Published April 2006. Originally
4.2 Thistestmethodisdesignedtoevaluatecombinationsof
approved in 1982. Last previous edition approved in 2000 as F732 – 00. DOI:
10.1520/F0732-00R06.
materials with respect to the amount of polymer wear, where
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
quantifiable wear occurs primarily on the polymeric compo-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
nent. With some combinations of materials, significant wear of
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. the counterface may occur, with subsequent embedding of
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F732–00 (2006)
counterfacedebrisparticlesinthepolymer.Suchanoccurrence that the serum contains a mass fraction of 0.2 to 0.3 % sodium
will render the weight loss of the polymer specimen unrel
...

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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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1.1 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. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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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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