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ASTM F3143-20

(Test Method)

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator

SIGNIFICANCE AND USE
5.1 This test procedure provides a method of evaluating the frictional torque and friction factor of hip replacement bearings.  
5.2 The procedure may be used as a standardized method of measuring friction to investigate the effects of specific test parameters such as hip materials, sizes, designs, radial or diametral clearance, different lubricants, different deformation levels of the acetabular cup, clamping (non-uniform sphericity), damaged/scratched bearings, artificial ageing, misalignments during installation, etc.  
5.3 Friction torque, and in particular the maximum value, is useful to assess the applicable torques that may compromise fixation, or even risk disassociation of modular components in the acetabular cup or liner/shell assemblies through a lever-out or torsion-out mechanism.  
5.4 Friction factor is a useful parameter for comparison of materials and designs, and provides insights into the lubrication regime operating in the implant system. Friction factor measurement may also be able to detect acetabular liner deformation (clamping referred to earlier).  
5.5 The loading and motion of a hip replacement in vivo differ from the loading and the motion defined in this standard. The amount of frictional forces in vivo will, in general, differ from the frictional forces evaluated by this standard test method. The results obtained from this test method cannot be used to directly predict in vivo performance. However, this standard is designed to allow for in-vitro comparisons for different hip designs, when tested under similar conditions.  
5.6 Although this test method can be used to investigate the many variables listed in 1.2 and 5.2, it does not either provide a method to determine beforehand the combination of these variables that will produce the worst-case couple(s) among a range of sizes; the worst-case testing condition(s) for “normal” or “adverse” conditions; or provide specific methods to deform the acetabular cup, simulate Mode 3 wear con...
SCOPE
1.1 This test procedure provides a method of determining the frictional torque and friction factor of artificial hip joint bearings used in total hip replacement (THR) systems under laboratory conditions using a reciprocal friction simulator. This test method specifies the angular movement between the articulating components, the pattern of applied force, and the way data can be measured and analyzed.  
1.2 Many variables can be investigated using this test method including, but not limited to, the effect of head size, different inclination/version angles, different deformation levels of the acetabular cup, bearing clearances, lubrication, scratched heads, and artificial ageing.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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.

General Information

Status
Published
Publication Date
30-Sep-2020
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

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ASTM F3143-20 - Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction SimulatorASTM F3143-20 - Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
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ASTM F3143-20 - Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
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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: F3143 − 20
Standard Test Method for
Determination of Frictional Torque and Friction Factor for
Hip Replacement Bearings under Standard Conditions
1
Using a Reciprocal Friction Simulator
This standard is issued under the fixed designation F3143; 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 E122 Practice for Calculating Sample Size to Estimate,With
Specified Precision, the Average for a Characteristic of a
1.1 This test procedure provides a method of determining
Lot or Process
the frictional torque and friction factor of artificial hip joint
F86 Practice for Surface Preparation and Marking of Metal-
bearings used in total hip replacement (THR) systems under
lic Surgical Implants
laboratoryconditionsusingareciprocalfrictionsimulator.This
3
test method specifies the angular movement between the
2.2 Other Standards:
articulating components, the pattern of applied force, and the
ISO 14242-1 Implants for Surgery—Wear of total hip-joint
way data can be measured and analyzed.
prostheses, Part 1: Loading and displacement parameters
forwear-testingmachinesandcorrespondingenvironmen-
1.2 Many variables can be investigated using this test
tal conditions for test
method including, but not limited to, the effect of head size,
ISO 14242-2 Implants for Surgery—Wear of total hip-joint
different inclination/version angles, different deformation lev-
prostheses, Part 2: Methods of measurement
els of the acetabular cup, bearing clearances, lubrication,
ISO 14242-3 Implants for Surgery—Wear of total hip-joint
scratched heads, and artificial ageing.
prostheses, Part 3: Loading and displacement parameters
1.3 The values stated in SI units are to be regarded as
for orbital bearing type wear testing machines and corre-
standard. No other units of measurement are included in this
sponding environmental conditions for test
standard.
1.4 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 Definitions:
responsibility of the user of this standard to establish appro-
3.1.1 friction, n—the resisting force tangential to the com-
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. mon boundary between two bodies when, under the action of
1.5 This international standard was developed in accor- an external force, one body moves or tends to move relative to
dance with internationally recognized principles on standard- the surface of the other.
ization established in the Decision on Principles for the
3.1.2 friction factor, n—in the spherical portions of articu-
Development of International Standards, Guides and Recom-
lar surfaces, friction factor is defined as an effective (nominal)
mendations issued by the World Trade Organization Technical
frictional coefficient, equal to the overall total tangential
Barriers to Trade (TBT) Committee.
frictional forces on the hip divided by the overall compressive
force on the hip.
2. Referenced Documents
2
3.1.3 frictional torque, n—in the case of spherical portions
2.1 ASTM Standards:
of articular surfaces such as those of a THR, the actual
E4 Practices for Force Verification of Testing Machines
frictionalforceatanyinstantvariesatdifferentlocationsonthe
surfaces.Theoverallfrictioncanbeconvenientlycharacterized
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
as a frictional torque, which represents the overall tangential
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
forces on the bearing surface multiplied by a nominal radius of
F04.22 on Arthroplasty.
the spherical articulating surfaces.
Current edition approved Oct. 1, 2020. Published November 2020. DOI:
10.1520/F3143-20.
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
3
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 ----------------------
F3143 − 20
3.1.4 overall tangential force, n—total of all tangential or “adverse” conditions; or
...

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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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
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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4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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  • Guide
    34 pages
    English language
    sale 15% off