ASTM F3129-16

Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses

SCOPE
1.1 This guide specifies a method to measure the surface and estimate the in-vivo material loss from the conical taper junctions, such as the femoral head/stem junction or adapter sleeve from explanted modular hip prosthesis, modular knee or shoulder joints. This guide is applicable to any articulating bearing material, stem material and conical taper size. The principles in this guide may be applied to other designs of taper junction, such as the modular stem/neck junction found in some hip joints.  
1.2 This guide covers the measurement of the surface and estimation of depth of material loss and volume of material loss and taper geometry using a Roundness Machine (1-4), Coordinate Measuring Machine (CMM) (5) and Optical Coordinate Measuring Machine (6, 7).2 Other measurement equipment may be used to measure the surface 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.
Note 1: The maximum depth of material loss is sensitive to the number and spacing of data points.  
1.3 The measurement techniques in this standard guide use measurements taken on the surface of the taper using stylus instruments. The material loss/corrosion mechanisms in the taper junction may lead to oxide layers or corrosion products deposited on the surface of the taper. These layers may lead to an underestimation of the volume of material loss.  
1.4 The explants may have debris or biological deposits on the surfaces of the taper junctions. These deposits will prevent the measurement of the actual surface of the taper junction and their effect on the measurement must be considered when deciding the cleaning protocol. Normally, the taper surfaces will be cleaned before measurements are taken.  
1.5 This standard may involve hazardous materials, operations and equipment. As a precautionary measure, explanted devices should be sterilized or minimally 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: Published
• Publication Date: 14-Apr-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Referred By: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 15-Apr-2016

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: F3129 − 16
Standard Guide for
Characterization of Material Loss from Conical Taper
1
Junctions in Total Joint Prostheses
This standard is issued under the fixed designation F3129; 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 This standard may involve hazardous materials, opera-
tions and equipment. As a precautionary measure, explanted
1.1 This guide specifies a method to measure the surface
devices should be sterilized or minimally disinfected by an
and estimate the in-vivo material loss from the conical taper
appropriate means that does not adversely affect the implant or
junctions, such as the femoral head/stem junction or adapter
the associated tissue that may be the subject of subsequent
sleeve from explanted modular hip prosthesis, modular knee or
analysis. A detailed discussion of precautions to be used in
shoulder joints. This guide is applicable to any articulating
handling human tissues can be found in ISO 12891-1. This
bearing material, stem material and conical taper size. The
standard does not purport to address all of the safety concerns,
principlesinthisguidemaybeappliedtootherdesignsoftaper
if any, associated with its use. It is the responsibility of the user
junction, such as the modular stem/neck junction found in
of this standard to establish appropriate safety and health
some hip joints.
practices and determine the applicability of regulatory limita-
1.2 This guide covers the measurement of the surface and tions prior to use.
estimationofdepthofmateriallossandvolumeofmaterialloss
and taper geometry using a Roundness Machine (1-4), Coor- 2. Referenced Documents
dinate Measuring Machine (CMM) (5) and Optical Coordinate 3
2.1 ASTM Standards:
2
Measuring Machine (6, 7). Other measurement equipment
F561 Practice for Retrieval and Analysis of Medical
may be used to measure the surface if the resolution and
Devices, and Associated Tissues and Fluids
accuracy of the measurements are comparable with the instru-
4
2.2 ISO Standards:
ments detailed in this standard. The measurement and analysis
ISO 12181-1-2003 Geometrical Product Specifications
protocols should be based on those described in this standard.
(GPS)—Roundness Part 1: Vocabulary and Parameters of
NOTE 1—The maximum depth of material loss is sensitive to the
Roundness
number and spacing of data points.
ISO 12181-2-2003 Geometrical Product Specifications
1.3 The measurement techniques in this standard guide use
(GPS)—Roundness Part 2: Specification Operators
measurements taken on the surface of the taper using stylus
ISO 4287:1997 Geometrical Product Specifications (GPS)—
instruments. The material loss/corrosion mechanisms in the
Surface Texture: Profile Method—Terms, Definitions and
taper junction may lead to oxide layers or corrosion products
Surface Texture Parameters
deposited on the surface of the taper. These layers may lead to
ISO 4287:1997/Cor 1:1998 Geometrical Product Specifica-
an underestimation of the volume of material loss.
tions (GPS)—Surface Texture: Profile Method—Surface
and its Parameters
1.4 The explants may have debris or biological deposits on
ISO 4287:1997/Cor 2:2005 Geometrical Product Specifica-
the surfaces of the taper junctions. These deposits will prevent
tions (GPS)—Surface Texture: Profile Method—
the measurement of the actual surface of the taper junction and
Measurement of Surface Roughness Parameters
their effect on the measurement must be considered when
ISO 25178-2 Geometric Product Specifications (GPS)—
deciding the cleaning protocol. Normally, the taper surfaces
Surface Texture: Areal—Part 2: Terms, Definitions and
will be cleaned before measurements are taken.
Surface Texture Parameters
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 [e-mail]. For Annual Book of ASTM
Current edition approved April 15, 2016. Published May 2016. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3129–16. 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.
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