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ASTM F3047M-15

(Guide)

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242 Part 1 or Part 3) stipulate only one load wave form 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 can be written that defines what a representative high demand wear test should include. 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.
SCOPE
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 of what high demand test features may need to be added to an overall high demand wear test regime. Device articulating components manufactured from other metallic alloys, ceramics or with coated or elementally modified surfaces could possibly be evaluated with this guide. However such materials may include risks and failure mechanisms which are not adressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal, ceramic-on-ceramic, 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
14-Mar-2015
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 F3047M-15 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard ArticulationsASTM F3047M-15 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
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ASTM F3047M-15 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
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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: F3047M − 15
Standard Guide for
High Demand Hip Simulator Wear Testing of Hard-on-hard
1
Articulations
This standard is issued under the fixed designation F3047M; 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 1.5 The values stated in SI units are to be regarded as the
standard.
1.1 The objective of this guide is to advise researchers on
1.6 This standard does not purport to address all of the
the possible high demand wear test features that should be
safety concerns, if any, associated with its use. It is the
included in evaluation of hard on hard articulations. This guide
responsibility of the user of this standard to establish appro-
makes suggestions of what high demand test features may need
priate safety and health practices and determine the applica-
to be added to an overall high demand wear test regime. Device
bility of regulatory limitations prior to use.
articulating components manufactured from other metallic
alloys, ceramics or with coated or elementally modified sur-
2. Referenced Documents
faces could possibly be evaluated with this guide. However
3
2.1 ASTM Standards:
such materials may include risks and failure mechanisms
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
which are not adressed in this guide.
Alloy Castings and Casting Alloy for Surgical Implants
1.2 Hard-on-hard hip bearing systems include metal-on-
(UNS R30075)
metal, ceramic-on-ceramic, ceramic-on-metal, or any other
F86 Practice for Surface Preparation and Marking of Metal-
bearing systems where both the head and cup components have
lic Surgical Implants
high surface hardness. An argument has been made that the
F799 Specification for Cobalt-28Chromium-6Molybdenum
hard-on-hard THR articulation may be better for younger more
Alloy Forgings for Surgical Implants (UNS R31537,
active patients. These younger patients may be more physically
R31538, R31539)
fit and expect to be able to perform more energetic activities.
F1537 Specification for Wrought Cobalt-28Chromium-
Consequently, new designs of hard-on-hard THR articulations
6Molybdenum Alloys for Surgical Implants (UNS
may have some implantations subjected to more demanding
R31537, UNS R31538, and UNS R31539)
and longer wear performance requirements.
F1814 Guide for Evaluating Modular Hip and Knee Joint
1.3 Total Hip Replacement (THR) with metal-on-metal Components
articulations have been used clinically for more than 50 years F1820 Test Method for Determining the Forces for Disas-
2
(1, 2). Early designs had mixed clinical results. Eventually sembly of Modular Acetabular Devices
they were eclipsed by THR systems using metal on polyeth- F1877 Practice for Characterization of Particles
ylene articulations. In the 1990s the metal-on-metal articula- F2033 Specification for Total Hip Joint Prosthesis and Hip
tion again became popular with more modern designs (3), Endoprosthesis Bearing Surfaces Made of Metallic,
including surface replacement. Ceramic, and Polymeric Materials
4
2.2 ISO Standards:
1.4 In the 1970s the first ceramic-on-ceramic THR articu-
ISO 5832-4 Implants for Surgery—Metallic Materials—Part
lations were used. In general, the early results were not
4: Cobalt-Chromium-Molybdenum Casting Alloy
satisfactory (4, 5). Improvement in alumina, and new designs
ISO 5832-12 Implants for Surgery—Metallic Materials—
in the 1990s improved the results for ceramic-on-ceramic
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
articulations (6).
ISO 7206-2 Implants for Surgery—Partial and Total Hip
Joint Prostheses—Part 2: Articulating Surfaces Made of
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.22 on Arthroplasty. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved March 15, 2015. Published May 2015. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3047M-15. the ASTM website.
2 4
The boldface numbers in parentheses refer to the list of references at the end of Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
this standard. 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 ----------------------
F3047M − 15
Metallic, Ceramic and Plastics Materials 3.1.3 acetabular liner/shell angle—the an
...

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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.  
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Standard Guide for Total Knee Replacement Loading Profiles

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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
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.
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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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
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.
SCOPE
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.  
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.

  • Guide
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    English language
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  • Guide
    8 pages
    English language
    sale 15% off