ASTM F2979-20

Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses

SCOPE
1.1 This standard guide provides options and a compendium of information for measuring the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (for example, ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads using a dimensional change method and is applicable to all prosthetic hip types, including stemmed (modular) and resurfacing hip systems.  
1.2 The methods specified in this guide are not applicable for measuring the in-vivo wear from non-articulating surfaces, for example modular connections (at the stem/neck, neck/head, or cup liner/shell interface) or at the acetabular cup rim.  
1.3 The parameters (wear depth and volumetric wear) evaluated and reported in this guide are estimated from the assumed as-manufactured shape of the components. The wear volume is calculated using a numerical integration method and the wear depth is the difference between the assumed as-manufactured shape and the measured surface.  
1.4 This guide covers the measurement of the depth of wear and the volumetric wear using a Coordinate Measuring Machine (CMM) and the depth of wear using an Roundness Machine. Other metrology measurement equipment may be used to measure the wear depth or volume if the resolution and accuracy of the measurements are comparable with the instruments detailed in this standard. The measurement and analysis protocols should be based on those described in this standard.  
1.5 This guide is applicable to hip joints which are nominally spherical at the time of manufacture. Form deviations resulting from manufacturing or deformation may occur and may necessitate the use of a non-spherical surface to represent the unworn surface of the component. Hip joints designed with asymmetry are considered beyond the scope of this guide, although the principles and techniques may be applicable to the characterization of wear from the articulating surfaces.  
1.6 This guide is intended as an extension to Practice F561 as a Stage II nondestructive test.  
1.7 This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices should be sterilized or disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. 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.  
1.8 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: 14-Dec-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

Standards Content (Sample)

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: F2979 − 20
Standard Guide for
Characterization of Wear from the Articulating Surfaces in
Retrieved Metal-on-Metal and other Hard-on-Hard Hip
1
Prostheses
This standard is issued under the fixed designation F2979; 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 althoughtheprinciplesandtechniquesmaybeapplicabletothe
characterization of wear from the articulating surfaces.
1.1 Thisstandardguideprovidesoptionsandacompendium
of information for measuring the bearing surface and estimat-
1.6 This guide is intended as an extension to Practice F561
ing the in-vivo wear of explanted Metal-on-Metal (MoM) and
as a Stage II nondestructive test.
other “hard” (for example, ceramic) hip components. The
1.7 This standard may involve hazardous materials,
guide covers the measurement of acetabular cups and femoral
operations, and equipment. As a precautionary measure, ex-
heads using a dimensional change method and is applicable to
planted devices should be sterilized or disinfected by an
all prosthetic hip types, including stemmed (modular) and
appropriate means that does not adversely affect the implant or
resurfacing hip systems.
the associated tissue that may be the subject of subsequent
1.2 The methods specified in this guide are not applicable
analysis. A detailed discussion of precautions to be used in
for measuring the in-vivo wear from non-articulating surfaces,
handling human tissues can be found in ISO 12891-1. This
forexamplemodularconnections(atthestem/neck,neck/head,
standard does not purport to address all of the safety concerns,
or cup liner/shell interface) or at the acetabular cup rim.
if any, associated with its use. It is the responsibility of the user
1.3 The parameters (wear depth and volumetric wear) of this standard to establish appropriate safety, health, and
evaluated and reported in this guide are estimated from the environmental practices and determine the applicability of
assumed as-manufactured shape of the components. The wear regulatory limitations prior to use.
volume is calculated using a numerical integration method and
1.8 This international standard was developed in accor-
the wear depth is the difference between the assumed as-
dance with internationally recognized principles on standard-
manufactured shape and the measured surface.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.4 This guide covers the measurement of the depth of wear
mendations issued by the World Trade Organization Technical
and the volumetric wear using a Coordinate Measuring Ma-
Barriers to Trade (TBT) Committee.
chine (CMM) and the depth of wear using an Roundness
Machine. Other metrology measurement equipment may be
2. Referenced Documents
used to measure the wear depth or volume if the resolution and
accuracy of the measurements are comparable with the instru-
2
2.1 ASTM Standards:
ments detailed in this standard. The measurement and analysis
E177 Practice for Use of the Terms Precision and Bias in
protocols should be based on those described in this standard.
ASTM Test Methods
1.5 This guide is applicable to hip joints which are nomi- E691 Practice for Conducting an Interlaboratory Study to
nally spherical at the time of manufacture. Form deviations
Determine the Precision of a Test Method
resulting from manufacturing or deformation may occur and F561 Practice for Retrieval and Analysis of Medical
may necessitate the use of a non-spherical surface to represent
Devices, and Associated Tissues and Fluids
the unworn surface of the component. Hip joints designed with F2033 Specification for Total Hip Joint Prosthesis and Hip
asymmetry are considered beyond the scope of this guide,
Endoprosthesis Bearing Surfaces Made of Metallic,
Ceramic, and Polymeric Materials
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
2
F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 15, 2020. Published January 2021. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2014. Last previous edition approved in 2014 as F2979 – 14. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2979-20. the ASTM website.
Copyright © ASTM In
...

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: F2979 − 14 F2979 − 20
Standard Guide for
Characterization of Wear from the Articulating Surfaces in
Retrieved Metal-on-Metal and other Hard-on-Hard Hip
1
Prostheses
This standard is issued under the fixed designation F2979; 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 This guide specifies a method to measure the standard guide provides options and a compendium of information for measuring
the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (e.g., (for example,
ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads using a dimensional change
method and is applicable to all prosthetic hip types, including stemmed (modular) and resurfacing hip systems.
1.2 The methods specified in this guide are not applicable for measuring the in-vivo wear from non-articulating surfaces, for
example modular connections (at the stem/neck, neck/headneck/head, or cup liner/shell interface) or at the acetabular cup rim.
1.3 The parameters (wear depth and volumetric wear) evaluated and reported in this guide are estimated from the assumed
as-manufactured shape of the components. The wear volume is calculated using a numerical integration method and the wear depth
is the difference between the assumed as-manufactured shape and the measured surface.
1.4 This guide covers the measurement of the depth of wear and the volumetric wear using a Coordinate Measuring Machine
(CMM) and the depth of wear using an Roundness Machine. Other metrology measurement equipment may be used to measure
the wear depth or volume if the resolution and accuracy of the measurements are comparable with the instruments detailed in this
standard. The measurement and analysis protocols should be based on those described in this standard.
1.5 This guide is applicable to hip joints which are nominally spherical at the time of manufacture. Form deviations resulting from
manufacturing or deformation may occur and may necessitate the use of a non-spherical surface to represent the unworn surface
of the component. Hip joints designed with asymmetry are considered beyond the scope of this guide, although the principles and
techniques may be applicable to the characterization of wear from the articulating surfaces.
1.6 This guide is intended as an extension to ASTMPractice F561 as a Stage II nondestructive test.
1.7 This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices
should be sterilized or disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that
may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found
in ISO 12891-1. 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 safety, health, and healthenvironmental practices and
determine the applicability of regulatory limitations prior to use.
1
This test method 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 Feb. 1, 2014Dec. 15, 2020. Published April 2014January 2021. Originally approved in 2014. Last previous edition approved in 2014 as
F2979 – 14. DOI: 10.1520/F2979-14.10.1520/F2979-20.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2979 − 20
1.8 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F561 Practice for Retrieval and Analysis of Medical
...