ASTM F2979-14

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 guide specifies a method to measure the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (e.g., 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 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 ASTM 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Jan-2014
• 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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F2979 − 14
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 1.6 This guide is intended as an extension toASTM F561 as
a Stage II nondestructive test.
1.1 This guide specifies a method to measure the in-vivo
1.7 This standard may involve hazardous materials, opera-
wear of explanted Metal-on-Metal (MoM) and other “hard”
tions and equipment. As a precautionary measure, explanted
(e.g., ceramic) hip components. The guide covers the measure-
devices should be sterilized or disinfected by an appropriate
mentofacetabularcupsandfemoralheadsusingadimensional
means that does not adversely affect the implant or the
change method and is applicable to all prosthetic hip types,
associated tissue that may be the subject of subsequent
including stemmed (modular) and resurfacing hip systems.
analysis. A detailed discussion of precautions to be used in
1.2 The methods specified in this guide are not applicable
handling human tissues can be found in ISO 12891-1. This
for measuring the in-vivo wear from non-articulating surfaces,
standard does not purport to address all of the safety concerns,
for example modular connections (at the stem/neck, neck/head
if any, associated with its use. It is the responsibility of the user
or cup liner/shell interface) or at acetabular cup rim.
of this standard to establish appropriate safety and health
1.3 The parameters (wear depth and volumetric wear)
practices and determine the applicability of regulatory limita-
evaluated and reported in this guide are estimated from the tions prior to use.
assumed as-manufactured shape of the components. The wear
volume is calculated using a numerical integration method and
2. Referenced Documents
the wear depth is the difference between the assumed as- 2
2.1 ASTM Standards:
manufactured shape and the measured surface.
F561 Practice for Retrieval and Analysis of Medical
1.4 This guide covers the measurement of the depth of wear Devices, and Associated Tissues and Fluids
and the volumetric wear using a Coordinate Measuring Ma- F2033 Specification for Total Hip Joint Prosthesis and Hip
chine (CMM) and the depth of wear using an Roundness Endoprosthesis Bearing Surfaces Made of Metallic,
Machine. Other metrology measurement equipment may be Ceramic, and Polymeric Materials
used to measure the wear depth or volume if the resolution and 3
2.2 ISO Standard:
accuracy of the measurements are comparable with the instru-
ISO 12181-1-2003 Part 1 – Geometrical product specifica-
ments detailed in this standard. The measurement and analysis
tions roundness, vocabulary and parameters of roundness
protocols should be based on those described in this standard.
3. Terminology
1.5 This guide is applicable to hip joints which are nomi-
nally spherical at the time of manufacture. Form deviations
3.1 Definitions:
resulting from manufacturing or deformation may occur and
3.1.1 For the purposes of this standard the following defi-
may necessitate the use of a non-spherical surface to represent
nitions shall apply.
the unworn surface of the component. Hip joints designed with
3.1.2 cup rim—the circle formed by the intersection of the
asymmetry are considered beyond the scope of this guide,
articulating surface and the plane normal to the revolution axis
althoughtheprinciplesandtechniquesmaybeapplicabletothe
thatliescoincidentwiththeextremepointoftheopencupface.
characterization of wear from the articulating surfaces.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.22 on Arthroplasty. the ASTM website.
3
Current edition approved Feb. 1, 2014. Published April 2014. DOI: 10.1520/ Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
F2979-14. 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
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F2979 − 14
FIG. 1 Schematic Diagram Terminology for Head and Cup Geometry
3.1.3 edge wear—the pattern of wear observed in acetabular c
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