ASTM F897-19
(Test Method)Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
SIGNIFICANCE AND USE
4.1 It is well known from examination of implants after use that plates and screws used for osteosynthesis are subjected to metal loss due to corrosion at the plate-screw interfaces. One of the mechanisms of this corrosive attack is fretting corrosion due to relative motion (micromotion) between the screw heads and plate-hole countersinks.
4.2 It is also known that release of corrosion products into the tissues surrounding an implant may have adverse effects on local tissue or have systemic effects. Thus, it is important to minimize the amount of tissue exposure to corrosion products.
4.3 Screws and plates are available in different configurations in accordance with Specifications F543 and F382. This test method may be used to evaluate the effects of different combinations of screw and plate designs. As new materials and device designs are developed for use in the treatment of fractured bones, it is important to determine the effects these developments have on the amount of metal loss due to fretting corrosion.
4.4 This test method provides a standardized screening test for ranking metal plates and screws in terms of resistance to fretting corrosion and for determining the influence of different solutions on fretting corrosion rates.
4.5 This test method may also be used to generate corrosion products either for chemical analysis of the products or for testing for biological reactions to corrosion products using animal or cell culture methods.
4.6 It is well known that fretting corrosion rates depend on normal load or pressure, frequency, sliding amplitude, materials, surface treatments, and environmental factors. (4) Therefore, when determining the effect of changing one of these parameters (for example, material or environment), all others must be kept constant to facilitate interpretation of the results.
SCOPE
1.1 This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The implants are used in the form they would be used clinically. The machine described generates a relative motion between plates and screws which simulates one type of motion pattern that can occur when these devices are used clinically.
1.2 Since the environmental and stress conditions used in this test method may not be identical to those experienced by bone plates in the human body, this test method may produce fretting corrosion rates that are lower or higher than those experienced in practice. The recommended axial load of 400 N was selected as being in a range where the amount of fretting corrosion is not sensitive to small changes in axial load (1).2 The combination of the recommended load and angular displacement are such that a measurable amount of fretting corrosion of surgical alloys occurs in a comparatively short period of time (7 to 14 days). (Refs 1-3)
1.3 The device is designed so as to facilitate sterilization of the test specimens and test chambers to permit testing with proteinaceous solutions that would become contaminated with microbial growth in nonsterile conditions.
1.4 The specimens used can be standard osteosynthesis implants or can be materials fabricated into the appropriate shapes.
1.5 This test method may be used for testing the fretting corrosion of metal plates and screws of similar or different alloy compositions, or it may be used for testing the fretting corrosion of metal-nonmetal combinations. This test method may also be used for wear or degradation studies of nonmetallic materials. This test method may be used as a screening test to rank the corrosivities of saline or proteinaceous solutions, or to rank metal-to-metal couples for resistance to fretting corrosion, or to study other material combinations.
1.6 The values stated in either SI unit...
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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: F897 − 19
Standard Test Method for
Measuring Fretting Corrosion of Osteosynthesis Plates and
1
Screws
ThisstandardisissuedunderthefixeddesignationF897;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope tallic materials. This test method may be used as a screening
test to rank the corrosivities of saline or proteinaceous
1.1 This test method provides a screening test for determin-
solutions, or to rank metal-to-metal couples for resistance to
ing the amount of metal loss from plates and screws used for
fretting corrosion, or to study other material combinations.
osteosynthesis (internal fixation of broken bones) due to
fretting corrosion in the contact area between the screw head 1.6 The values stated in either SI units or inch-pound units
and the plate hole countersink area. The implants are used in are to be regarded separately as standard. The values stated in
the form they would be used clinically. The machine described each system are not necessarily exact equivalents; therefore, to
generates a relative motion between plates and screws which ensure conformance with the standard, each system shall be
simulates one type of motion pattern that can occur when these used independently of the other, and values from the two
devices are used clinically. systems shall not be combined.
1.7 This standard does not purport to address all of the
1.2 Since the environmental and stress conditions used in
safety concerns, if any, associated with its use. It is the
this test method may not be identical to those experienced by
responsibility of the user of this standard to establish appro-
bone plates in the human body, this test method may produce
priate safety, health, and environmental practices and deter-
fretting corrosion rates that are lower or higher than those
mine the applicability of regulatory limitations prior to use.
experienced in practice.The recommended axial load of 400 N
1.8 This international standard was developed in accor-
was selected as being in a range where the amount of fretting
2
dance with internationally recognized principles on standard-
corrosion is not sensitive to small changes in axial load (1).
ization established in the Decision on Principles for the
The combination of the recommended load and angular dis-
Development of International Standards, Guides and Recom-
placement are such that a measurable amount of fretting
mendations issued by the World Trade Organization Technical
corrosion of surgical alloys occurs in a comparatively short
Barriers to Trade (TBT) Committee.
period of time (7 to 14 days). (Refs 1-3)
1.3 The device is designed so as to facilitate sterilization of
2. Referenced Documents
the test specimens and test chambers to permit testing with
3
2.1 ASTM Standards:
proteinaceous solutions that would become contaminated with
D1886 Test Methods for Nickel in Water
microbial growth in nonsterile conditions.
F86 Practice for Surface Preparation and Marking of Metal-
1.4 The specimens used can be standard osteosynthesis
lic Surgical Implants
implants or can be materials fabricated into the appropriate
F382 SpecificationandTestMethodforMetallicBonePlates
shapes.
F543 Specification and Test Methods for Metallic Medical
1.5 This test method may be used for testing the fretting Bone Screws
corrosion of metal plates and screws of similar or different G1 Practice for Preparing, Cleaning, and Evaluating Corro-
alloy compositions, or it may be used for testing the fretting sion Test Specimens
corrosion of metal-nonmetal combinations. This test method
3. Summary of Test Method
may also be used for wear or degradation studies of nonme-
3.1 A two-hole plate is attached to two plastic rods with
bone screws, with flexible spacers between the plate and the
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
rods, placed in a glass beaker, and the beaker sealed with a
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Nov. 1, 2019. Published December 2019. Originally
3
approvedin1984.Lastpreviouseditionapprovedin2013asF897 – 02(2013).DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/F0897-19. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, r
...
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: F897 − 02 (Reapproved 2013) F897 − 19
Standard Test Method for
Measuring Fretting Corrosion of Osteosynthesis Plates and
1
Screws
This standard is issued under the fixed designation F897; 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 test method provides a screening test for determining the amount of metal loss from plates and screws used for
osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate
hole countersink area. The implants are used in the form they would be used clinically. The machine described generates a relative
motion between plates and screws which simulates one type of motion pattern that can occur when these devices are used clinically.
1.2 Since the environmental and stress conditions used in this test method may not be identical to those experienced by bone
plates in the human body, this test method may produce fretting corrosion rates that are lower or higher than those experienced
in practice. The recommended axial load of 400 N was selected as being in a range where the amount of fretting corrosion is not
2
sensitive to small changes in axial load (1). The combination of the recommended load and angular displacement are such that
a measurable amount of fretting corrosion of surgical alloys occurs in a comparatively short period of time (7 to 14 days). (Refs
1-3)
1.3 The device is designed so as to facilitate sterilization of the test specimens and test chambers to permit testing with
proteinaceous solutions that would become contaminated with microbial growth in nonsterile conditions.
1.4 The specimens used can be standard osteosynthesis implants or can be materials fabricated into the appropriate shapes.
1.5 This test method may be used for testing the fretting corrosion of metal plates and screws of similar or different alloy
compositions, or it may be used for testing the fretting corrosion of metal-nonmetal combinations. This test method may also be
used for wear or degradation studies of nonmetallic materials. This test method may be used as a screening test to rank the
corrosivities of saline or proteinaceous solutions, or to rank metal-to-metal couples for resistance to fretting corrosion, or to study
other material combinations.
1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, and values from the two systems shall not be combined.
1.7 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all
of the safety concerns concerns, if any, associated with its use. It is the responsibility of whoever uses the user of this standard
to consult and establish appropriate safety safety, health, and healthenvironmental 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.
2. Referenced Documents
3
2.1 ASTM Standards:
D1886 Test Methods for Nickel in Water
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved March 1, 2013Nov. 1, 2019. Published March 2013December 2019. Originally approved in 1984. Last previous edition approved in 20072013
as F897 – 02(2007).(2013). DOI: 10.1520/F0897-02R13.10.1520/F0897-19.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page o
...
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