ASTM F1875-98(2022)
(Practice)Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
SIGNIFICANCE AND USE
5.1 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.
5.2 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.
5.3 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.
5.4 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.
5.5 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).2 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 is also assessed by characterization of the damage to the bore and cone surfaces (4, 5).
1.1.2 Method 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 permits simultaneous evaluation of the fatigue strength of a femoral ...
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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: F1875 − 98 (Reapproved 2022)
Standard Practice for
Fretting Corrosion Testing of Modular Implant Interfaces:
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 portion of the coupon identical in design, manufacturing, and
materials to the taper of the final hip implant (4, 5).
1.1 This practice describes the testing, analytical, and char-
acterization methods for evaluating the mechanical stability of 1.4 Method I of this practice permits simultaneous evalua-
the bore and cone interface of the head and stem junction of tionofthefatiguestrengthofafemoralhipstem(inaccordance
modular hip implants subjected to cyclic loading by measure- with Practice F1440) and the mechanical stability and debris
ments of fretting corrosion (1-5). Two test methods described generated by fretting and fretting corrosion of the modular
are as follows: interface.
1.1.1 Method I—The primary purpose of this method is to
1.5 The general concepts and methodologies described in
provide a uniform set of guidelines for long-term testing to
this practice could be applied to the study of other modular
determine the amount of damage by measurement of the
interfaces in total joint prostheses.
production of corrosion products and particulate debris from
1.6 The values stated in SI units are to be regarded as
fretting and fretting corrosion. Damage is also assessed by
standard. No other units of measurement are included in this
characterization of the damage to the bore and cone surfaces
standard.
(4, 5).
1.7 This standard does not purport to address all of the
1.1.2 Method II—This method provides for short-term elec-
trochemical evaluation of the fretting corrosion of the modular safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
interface. It is not the intent of this method to produce damage
nor particulate debris but rather to provide a rapid method for priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
qualitative assessment of design changes which do not include
material changes (1-4). 1.8 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.2 This practice does not provide for judgment or predic-
ization established in the Decision on Principles for the
tion of in-vivo implant performance, but rather provides for a
Development of International Standards, Guides and Recom-
uniform set of guidelines for evaluating relative differences in
mendations issued by the World Trade Organization Technical
performance between differing implant designs, constructs, or
Barriers to Trade (TBT) Committee.
materials with performance defined in the context of the
amount of fretting and fretting corrosion. Also, this practice
2. Referenced Documents
should permit direct comparison of fretting corrosion data
2.1 ASTM Standards:
between independent research groups, and thus provide for
E4 Practices for Force Calibration and Verification of Test-
building of a data base on modular implant performance.
ing Machines
1.3 This practice provides for comparative testing of manu-
E466 Practice for Conducting Force Controlled Constant
factured hip femoral heads and stems and for coupon-type
Amplitude Axial Fatigue Tests of Metallic Materials
specimen testing where the male taper portion of the modular
E467 Practice for Verification of Constant Amplitude Dy-
junction does not include the entire hip implant, with the taper
namic Forces in an Axial Fatigue Testing System
F561 Practice for Retrieval and Analysis of Medical
Devices, and Associated Tissues and Fluids
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
F746 Test Method for Pitting or Crevice Corrosion of
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved Oct. 1, 2022. Published October 2022. Originally
approved in 1998. Last previous edition approved in 2014 as F1875 – 98 (2014). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F1875-98R22. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
The bold face numbers in parentheses refers to the list of references at the end Standards volume information, refer to the standard’s Document Summary page on
of this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1875 − 98 (2022)
Metallic Surgical Implant Materials 3.1.9 total elemental level, n—the total weight of particulate
F897 Test Method for Measuring Fretting Corrosion of matter and corrosion ions generated by fretting wear and
Osteosynthesis Plates and Screws fretting corrosion. Most analytical techniques are unable to
F1440 Practice for Cyclic Fatigue Testing of Metallic accurately differentiate between ions and particulates, and
Stemmed HipArthroplasty Femoral Components Without therefore, total elemental level refers to all matter and corro-
Torsion (Withdrawn 2012) sion products released by fretting wear and corrosion.
F1636 SpecificationforBoresandConesforModularFemo-
3.1.10 wear, n—damage to a solid surface, generally involv-
ral Heads (Withdrawn 2001)
ingprogressivelossofmaterial,duetorelativemotionbetween
G3 Practice for Conventions Applicable to Electrochemical
that surface and a contacting substance or substances.
Measurements in Corrosion Testing
G5 Reference Test Method for Making Potentiodynamic
4. Summary of Test Method
Anodic Polarization Measurements
4.1 Method I—The femoral stem and head components, or
G15 Terminology Relating to Corrosion and CorrosionTest-
coupons to simulate head-taper-neck geometry, are loaded
ing (Withdrawn 2010)
cyclically in a manner similar to that described in Practice
G40 Terminology Relating to Wear and Erosion
F1440. The head neck junction is exposed to a saline or
G61 Test Method for Conducting Cyclic Potentiodynamic
proteinaceous solution, either by immersion of the entire
Polarization Measurements for Localized Corrosion Sus-
device, or with a fluid-containing envelope. The cyclic load is
ceptibility of Iron-, Nickel-, or Cobalt-Based Alloys
applied for a minimum of 10 million cycles.At the conclusion
G102 Practice for Calculation of Corrosion Rates and Re-
of testing, the isolated fluid is withdrawn for chemical analysis
lated Information from Electrochemical Measurements
for total elemental level, and characterization of particulate
2.2 ISO Standards:
debris. The taper interface is subsequently disengaged and the
ISO 7206-7 Endurance Performance of Stemmed Femoral
surfaces inspected for fretting wear and corrosion using optical
Components Without Application of Torsion
microscopy and scanning electron microscopy. The output of
3. Terminology thesemethodsisaquantitativemeasureoftotalelementallevel
andaqualitativeevaluationofdamageofthemodularinterface
3.1 Definitions:
caused by fretting wear and corrosion.
3.1.1 corrosive wear, n—wear in which chemical or electro-
chemical reaction with the environment is significant.
4.2 Method II—A coupon similar to that used in Method I,
or an entire femoral stem and head construct, may be mounted
3.1.2 coverage, n—the length, parallel to the taper surface,
in an inverted position in a test chamber. The chamber is filled
that the bore and cone interfaces are in contact.
withanelectrolytesolutiontoalevelsufficienttosubmergethe
3.1.3 crevice corrosion, n—localized corrosion of a metal
bore and cone interface and a small portion of the exposed
surface at, or immediately adjacent to, an area that is shielded
neck. The area of contact and articulation between the ball and
from full exposure to the environment because of close
the test apparatus is isolated from the electrolyte, either by
proximity between the metal and the surface of another
being above the fill level, or with an elastomeric seal used to
material.
isolate the bottom of the test chamber.
3.1.4 external circuit, n—the wires, connectors, measuring
4.2.1 Procedure A—A saturated calomel electrode with a
devices, current sources, and so forth that are used to bring
luggin probe is used as a reference electrode to measure
about or measure the desired electrical conditions within the
changes in the corrosion potential with an electrometer. A
test cell.
counter electrode also may be employed and the polarization
3.1.5 femoral head neck extension, n—a distance parallel to
characteristics measured with a potentiostat.
the taper axis, from the nominal neck offset length (k)as
4.2.2 Procedure B—Alargesurfaceareacounterelectrodeis
defined in Specification F1636, and the center of the head.
immersed in the solution to simulate the area of the stem. A
Such variants from the nominal length are used to adjust for
zero-resistance ammeter is connected between the test device
resection level, leg length, and so forth. A positive neck
and the counter electrode. The difference in current, thus
extension equates to the center of the head being located
measured prior to and during cyclic loading, represents the
further away from the stem.
fretting corrosion current flowing between the modular inter-
face (anode) and the metal sheet (cathode).
3.1.6 fretting, n—small amplitude oscillatory motion, usu-
ally tangential, between two solid surfaces in contact.
5. Significance and Use
3.1.7 fretting corrosion, n—the deterioration at the interface
between contacting surfaces as the result of corrosion and
5.1 The modular interfaces of total joint prostheses are
slight oscillatory slip between the two surfaces.
subjected to micromotion that could result in fretting and
corrosion. The release of corrosion products and particulate
3.1.8 fretting wear, n—wear arising as a result of fretting.
debris could stimulate adverse biological reactions, as well as
lead to accelerated wear at the articulation interface. Methods
The last approved version of this historical standard is referenced on
to assess the stability and corrosion resistance of the modular
www.astm.org.
interfaces, therefore, are an essential component of device
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036. testing.
F1875 − 98 (2022)
5.2 Long-term in-vitro testing is essential to produce dam-
age and debris from fretting of a modular interface (4, 5). The
useofproteinaceoussolutionsisrecommendedtobestsimulate
the in-vivo environment.
5.3 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 mechani-
cal and electrochemical processes to the total corrosion and
particulate release phenomena, however, have not been estab-
lished; therefore, these tests should not be utilized to compare
the effects of changes in material combinations, but rather be
NOTE 1—For Method I, the fluid is contained within the sleeve. For
utilized to evaluate design changes of bore (head) and cone
Method II, the device should be submerged in an electrolyte while the
(stem) components.
contact area between the top of the head and the loading apparatus is not
exposed to the fluid. A counter electrode is placed in the same bath.
5.4 These tests are recommended for evaluating the fretting
wear and corrosion of modular interfaces of hip femoral head
FIG. 1 Sketch of a Coupon Style of Test Specimen
andstemcomponents.Similarmethodsmaybeappliedtoother
modular interfaces where fretting corrosion is of concern.
5.5 These methods are recommended for comparative
evaluation of the fretting wear and corrosion of new materials,
coatings, or designs, or a combination thereof, under consid-
eration 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.
6. Apparatus
6.1 Testing Machines—The action of the machine should be
analyzedthereaftertoensurethatthedesiredformandperiodic
force amplitude is maintained for the duration of the test (see
Practice E467). The test machine should have a load monitor-
ing system, such as the transducer mounted in line with the
specimen. The loads should be monitored continuously in the
early stages of the test and periodically thereafter to ensure the
NOTE 1—The cathode sheet surrounds but does not make contact with
desired load cycle is maintained. The varying load as deter-
the device being tested. For Procedure A, the counter electrode is not
minedbysuitabledynamicverificationshouldbemaintainedat
utilized, and is substituted with a luggin probe and calomel electrode.
all times to within 62 % of the maximum force being used in
accordance with Practices E4 and E466.
FIG. 2 Suggested Setup for Method II Procedure B, Measure-
ments of Fretting Corrosion Currents of a Complete THR
6.2 Specimen Mounting Devices, Method I—Modular hip
and stem components shall be set up as described in Practice
F1440. Coupon samples shall be set up as shown in Fig. 1.The
setup must provide for identical loading geometry as that in
and capable of retaining the fluid environment (that is, prevent
Practice F1440.
leakage) throughout the course of testing. The volume of the
6.3 Specimen Mounting Devices, Method II—Modular hip
chamber shall be between 5 and 100 mL.
and stem components shall be set up in an inverted position, as
NOTE 1—The use of small fluid volumes with the sleeve containment
shown in Fig. 2. Coupon samples may be set up as shown in
method may not produce as much fretting corrosion as full prosthesis
Fig. 1, or in an inverted orientation.
exposure, due to the reduced surface area of the cathodic metal exposed.
6.4 Environmental Containment, Method I—The prosthesis 6.5 Environmental Chamber, Method II—The chamber shall
may be placed in an environmental chamber, which is filled be filled with electrolyte so as to submerge the modular
with the appropriate fluid. Care sho
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