ASTM F1875-98(2004)

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface

SIGNIFICANCE AND USE
The modular interfaces of total joint prostheses are subjected to micromotion that could result in fretting and corrosion. The release of corrosion products and particulate debris could stimulate adverse biological reactions, as well as lead to accelerated wear at the articulation interface. Methods to assess the stability and corrosion resistance of the modular interfaces, therefore, are an essential component of device testing.  
Long-term in vitro testing is essential to produce damage and debris from fretting of a modular interface  (4,5). The use of proteinaceous solutions is recommended to best simulate the in vivo environment.
Short-term tests often can be useful in evaluations of differences in design during device development (1-4). The electrochemical methods provide semiquantitative measures of fretting corrosion rates. The relative contributions of mechanical and electrochemical processes to the total corrosion and particulate release phenomena, however, have not been established; therefore, these tests should not be utilized to compare the effects of changes in material combinations, but rather be utilized to evaluate design changes of bore (head) and cone (stem) components.
These tests are recommended for evaluating the fretting wear and corrosion of modular interfaces of hip femoral head and stem components. Similar methods may be applied to other modular interfaces where fretting corrosion is of concern.
These methods are recommended for comparative evaluation of the fretting wear and corrosion of new materials, coatings, or designs, or a combination thereof, under consideration for hip femoral head and neck modular interfaces. Components for testing may be those of a manufactured modular hip device (finished product) or sample coupons, which are designed and manufactured for simulation of the head, taper, and neck region of a modular hip device.
SCOPE
1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion. (1-5) Two test methods described are as follows:
1.1.1 Method I-The primary purpose of this method is to provide a uniform set of guidelines for long-term testing to determine the amount of damage by measurement of the production of corrosion products and particulate debris from fretting and fretting corrosion. Damage also is assessed by characterization of the damage to the bore and cone surfaces. (4,5)
1.1.2 Methods II-This method provides for short-term electrochemical evaluation of the fretting corrosion of the modular interface. It is not the intent of this method to produce damage nor particulate debris but rather to provide a rapid method for qualitative assessment of design changes which do not include material changes. (1-4)
1.2 This practice does not provide for judgment or prediction of in vivo implant performance, but rather, provides for a uniform set of guidelines for evaluating relative differences in performance between differing implant designs, constructs, or materials with performance defined in the context of the amount of fretting and fretting corrosion. Also, this practice should permit direct comparison of fretting corrosion data between independent research groups, and thus, provide for building of a data base on modular implant performance.
1.3 This practice provides for comparative testing of manufactured hip femoral heads and stems and for coupon type specimen testing where the male taper portion of the modular junction does not include the entire hip implant, with the taper portion of the coupon identical in design, manufacturing, and materials to the taper of the final hip implant. (4,5)
1.4 Method I of this practice has been provided in a manner to permit simultaneous evaluation of the fatigue strength of a femor...

General Information

• Status: Historical
• Publication Date: 31-Jul-2004
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F1875-98 - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
• Effective Date: 01-Aug-2004
• Replaced By: ASTM F1875-98(2009) - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
• Effective Date: 01-Dec-2009
• Referred By: ASTM F1814-22 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
• Effective Date: 01-Aug-2004

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information.
Designation:F1875–98 (Reapproved2004)
Standard Practice for
Fretting Corrosion Testing of Modular Implant Interfaces:
1
Hip Femoral Head-Bore and Cone Taper Interface
This standard is issued under the fixed designation F1875; 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 1.4 Method I of this practice has been provided in a manner
to permit simultaneous evaluation of the fatigue strength of a
1.1 This practice describes the testing, analytical, and char-
femoral hip stem (in accordance with Practice F1440) and the
acterization methods for evaluating the mechanical stability of
mechanical stability and debris generated by fretting and
the bore and cone interface of the head and stem junction of
fretting corrosion of the modular interface.
modular hip implants subjected to cyclic loading by measure-
2 1.5 The general concepts and methodologies described in
ments of fretting corrosion (1-5). Two test methods described
this practice could be applied to the study of other modular
are as follows:
interfaces in total joint prostheses.
1.1.1 Method I—The primary purpose of this method is to
1.6 This standard may involve hazardous materials, opera-
provide a uniform set of guidelines for long-term testing to
tions, and equipment. This standard does not purport to
determine the amount of damage by measurement of the
address all of the safety concerns, if any, associated with its
production of corrosion products and particulate debris from
use. It is the responsibility of the user of this standard to
fretting and fretting corrosion. Damage also is assessed by
establish appropriate safety and health practices and deter-
characterization of the damage to the bore and cone surfaces
mine the applicability of regulatory limitations prior to use.
(4, 5).
1.1.2 Methods II—This method provides for short-term
2. Referenced Documents
electrochemical evaluation of the fretting corrosion of the
3
2.1 ASTM Standards:
modular interface. It is not the intent of this method to produce
E4 Practices for Force Verification of Testing Machines
damage nor particulate debris but rather to provide a rapid
E466 Practice for Conducting Force Controlled Constant
method for qualitative assessment of design changes which do
Amplitude Axial Fatigue Tests of Metallic Materials
not include material changes (1-4).
E467 Practice for Verification of Constant Amplitude Dy-
1.2 This practice does not provide for judgment or predic-
namic Forces in an Axial Fatigue Testing System
tion of in vivo implant performance, but rather, provides for a
F561 Practice for Retrieval and Analysis of Medical De-
uniform set of guidelines for evaluating relative differences in
vices, and Associated Tissues and Fluids
performance between differing implant designs, constructs, or
F746 Test Method for Pitting or Crevice Corrosion of
materials with performance defined in the context of the
Metallic Surgical Implant Materials
amount of fretting and fretting corrosion. Also, this practice
F897 Test Method for Measuring Fretting Corrosion of
should permit direct comparison of fretting corrosion data
Osteosynthesis Plates and Screws
between independent research groups, and thus, provide for
F1440 Practice for Cyclic Fatigue Testing of Metallic
building of a data base on modular implant performance.
Stemmed Hip Arthroplasty Femoral Components Without
1.3 This practice provides for comparative testing of manu-
4
Torsion
factured hip femoral heads and stems and for coupon type
F1636 Specification for Bores and Cones for Modular
specimen testing where the male taper portion of the modular
5
Femoral Heads
junction does not include the entire hip implant, with the taper
G3 Practice for ConventionsApplicable to Electrochemical
portion of the coupon identical in design, manufacturing, and
Measurements in Corrosion Testing
materials to the taper of the final hip implant (4,5).
G5 Reference Test Method for Making Potentiostatic and
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.15 on Material Test Methods. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved Aug. 1, 2004. Published August 2004. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 1998. Last previous edition approved in 1998 as F1875 – 98. DOI: the ASTM website.
4
10.1520/F1875-98R04. Withdrawn.
2 5
The bold face numbers in parentheses re
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