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ASTM F 3047M : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
Hardcopy , PDF
30-06-2023
English
18-05-2015
CONTAINED IN VOL. 13.02, 2015 Pertains to advise researchers on the possible high demand wear test features that should be included in evaluation of hard on hard articulations.
Committee |
F 04
|
DocumentType |
Guide
|
Pages |
8
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy |
1.1The 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.
1.2Hard-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.
1.3Total 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.
1.4In 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).
1.5The values stated in SI units are to be regarded as the standard.
1.6This 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.
EN ISO 21535:2009/A1:2016 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007/AMD 1:2016) |
DIN EN ISO 21535:2017-04 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016) |
BS EN ISO 21535 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
ASTM F 3018 : 2017 | Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
DIN EN ISO 21535:2009-08 | NICHTAKTIVE CHIRURGISCHE IMPLANTATE - IMPLANTATE ZUM GELENKERSATZ - BESONDERE ANFORDERUNGEN AN IMPLANTATE FUER DEN HUEFTGELENKERSATZ (ISO 21535:2007 + AMD 1:2016) |
DIN EN ISO 21535 E : 2017 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016) |
ISO 21535:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
I.S. EN ISO 21535:2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
ASTM F 1877 : 2016 : REDLINE | Standard Practice for Characterization of Particles |
ASTM F 86 : 2013 : REDLINE | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ASTM F 1877 : 2005 | Standard Practice for Characterization of Particles |
ASTM F 2033 : 2000 : REV A | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
ASTM F 1820 : 1997 | Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device |
ISO 14242-1:2014 | Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
ASTM F 75 : 2023 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
ASTM F 1537 : 2011 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ASTM F 1820 : 2022 | Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
ASTM F 75 : 2018 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
ASTM F 86 : 2013 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ISO 14242-3:2009 | Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test |
ASTM F 1820 : 2013 : REDLINE | Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
ASTM F 2033 : 2012 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
ASTM F 1814 : 1997 : REV A | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
ISO 14242-2:2016 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
ASTM F 1537 : 2008 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ASTM F 1820 : 2013 | Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
ASTM F 1537 : 2007 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ISO 17853:2011 | Wear of implant materials Polymer and metal wear particles Isolation and characterization |
ISO 5832-4:2014 | Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy |
ASTM F 1814 : 2015 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
ASTM F 1537 : 2020 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ASTM F 1537 : 2011 : REDLINE | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ASTM F 1877 : 2016 | Standard Practice for Characterization of Particles |
ASTM F 1820 : 1997 : R2003 | Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device |
ASTM F 1814 : 2015 : REDLINE | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
ASTM F 2033 : 2005 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
ASTM F 1820 : 1997 : R2009 | Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device |
ASTM F 1877 : 1998 | Standard Practice for Characterization of Particles |
ASTM F 86 : 2021 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ISO 7206-2:2011 | Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
ASTM F 1814 : 1997 : REV A : R2003 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
ASTM F 1537 : 2000 | Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
ASTM F 1877 : 2005 : R2010 | Standard Practice for Characterization of Particles |
ASTM F 1877 : 2005 : EDT 1 | Standard Practice for Characterization of Particles |
ASTM F 1814 : 1997 : REV A : R2009 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
ASTM F 2033 : 2012 : REDLINE | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
ASTM F 799 : 2011 : REDLINE | SPECIFICATION FOR COBALT-28CHROMIUM-6MOLYBDENUM ALLOY FORGINGS FOR SURGICAL IMPLANTS (UNS R31537, R31538, R31539) |
ISO 5832-12:2007 | Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy |
ASTM F 1814 : 2022 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
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