ASTM F3047M-23
(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 14242-1 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.
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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: F3047M − 23
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 satisfactory (4, 5). Improvement in alumina, and new designs
in the 1990s improved the results for ceramic-on-ceramic
1.1 The objective of this guide is to advise researchers on
articulations (6).
the possible high demand wear test features that should be
included in evaluation of hard-on-hard articulations. This guide 1.5 The values stated in SI units are to be regarded as the
makes suggestions for high demand test features that may need standard.
to be added to an overall wear test regime. Device articulating
1.6 This standard does not purport to address all of the
components manufactured from other metallic alloys,
safety concerns, if any, associated with its use. It is the
ceramics, or with coated or elementally modified surfaces
responsibility of the user of this standard to establish appro-
without significant clinical use could possibly be evaluated
priate safety, health, and environmental practices and deter-
with this guide. However, such materials may include risks and
mine the applicability of regulatory limitations prior to use.
failure mechanisms that are not addressed in this guide.
1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.2 Hard-on-hard hip bearing systems include metal-on-
ization established in the Decision on Principles for the
metal (for example, Specifications F75, F799, and F1537; ISO
Development of International Standards, Guides and Recom-
5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO
mendations issued by the World Trade Organization Technical
6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any
Barriers to Trade (TBT) Committee.
other bearing systems where both the head and cup compo-
nents have high surface hardness. An argument has been made
2. Referenced Documents
that the hard-on-hard THR articulation may be better for
3
younger, more active patients. These younger patients may be
2.1 ASTM Standards:
more physically fit and expect to be able to perform more
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
energetic activities. Consequently, new designs of hard-on-
Alloy Castings and Casting Alloy for Surgical Implants
hard THR articulations may have some implantations subjected
(UNS R30075)
to more demanding and longer wear performance require-
F86 Practice for Surface Preparation and Marking of Metal-
ments.
lic Surgical Implants
F561 Practice for Retrieval and Analysis of Medical
1.3 Total Hip Replacement (THR) with metal-on-metal
Devices, and Associated Tissues and Fluids
articulations have been used clinically for more than 50 years
2
F799 Specification for Cobalt-28 Chromium-6 Molybdenum
(1, 2). Early designs had mixed clinical results. Eventually
Alloy Forgings for Surgical Implants (UNS R31537,
they were eclipsed by THR systems using metal-on-
R31538, R31539)
polyethylene articulations. In the 1990s the metal-on-metal
F1537 Specification for Wrought Cobalt-28Chromium-
articulation again became popular with more modern designs
6Molybdenum Alloys for Surgical Implants (UNS
(3), including surface replacement.
R31537, UNS R31538, and UNS R31539)
1.4 In the 1970s the first ceramic-on-ceramic THR articu-
F1877 Practice for Characterization of Particles
lations were used. In general, the early results were not
F2033 Specification for Total Hip Joint Prosthesis and Hip
Endoprosthesis Bearing Surfaces Made of Metallic,
Ceramic, and Polymeric Materials
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
F3018 Guide for Assessment of Hard-on-Hard Articulation
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved June 1, 2023. Published June 2023. Originally
3
approved in 2015. Last previous edition approved in 2015 as F3047M – 15. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/F3047M-23. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © AST
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3047M − 15 F3047M − 23
Standard Guide for
High Demand Hip Simulator Wear Testing of Hard-on-
1
hardHard-on-Hard 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
1.1 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 hard-on-hard articulations. This guide makes suggestions of what for high demand test features that 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 without significant clinical use could possibly be evaluated with
this guide. However, such materials may include risks and failure mechanisms whichthat are not adressedaddressed in this guide.
1.2 Hard-on-hard hip bearing systems include metal-on-metal, ceramic-on-ceramic, 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.
2
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2). Early
designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal on polyethylene 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 healthsafety, 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.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.22
on Arthroplasty.
Current edition approved March 15, 2015June 1, 2023. Published May 2015June 2023. Originally approved in 2015. Last previous edition approved in 2015 as
F3047M – 15. DOI: 10.1520/F3047M-15.10.1520/F3047M-23.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F3047M − 23
2. Referenced Documents
3
2.1 ASTM Standards:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F799 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F1814 Guide for Evaluating Modul
...
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