ASTM F3044-20
(Test Method)Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
SIGNIFICANCE AND USE
3.1 Implantable medical devices can be made of dissimilar metals or come into electrical contact with dissimilar metals leading to the potential for galvanic corrosion, which may result in the release of corrosion products with harmful biological consequences or a compromise of structural integrity of the device. Therefore, it is important to determine the susceptibility of these types of devices to galvanic corrosion.
3.2 Use of this test method is intended to provide information on the possible galvanic component of corrosion of two dissimilar metals in contact with one another. The dissimilar metals in contact may be on the same implantable medical device or as component parts of individual medical implant devices.
3.3 This test method has been designed to accommodate a wide variety of device shapes and sizes encountered by allowing the use of a variety of holding devices.
3.4 This standard is presented as a test method for conducting galvanic corrosion tests in a simulated physiological environment. Adherence to this test method should aid in avoiding some of the inherent difficulties in such testing. Other standards such as Guide G71 are general and, while they provide valuable background information, do not provide the necessary details or specificity for testing medical device implants.
SCOPE
1.1 This test method covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the types of devices that might be assessed include overlapping stents of different alloys, stent and stent marker combinations, orthopedic plates and screws where one or more of the screws are of a different alloy than the rest of the device, and multi-part constructs where two or more alloys are used for the various component parts. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method.
1.2 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize the behavior of galvanic couples in an electrolyte.
1.3 Devices and device components are intended to be tested in their finished condition, as would be implanted (that is, the metallurgical and surface condition of the sample should be in or as close as possible to the same condition as in the finished device).
1.4 This test method does not address other types of corrosion and degradation damage that may occur in a device such as fretting, crevices, or the effect of any galvanically induced potentials on stress corrosion and corrosion fatigue. Surface modifications, such as from scratches (possibly introduced during implantation) or effects of welding (during manufacture), are also not addressed. These mechanisms are outside of the scope of this test method.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location.
1.7 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, health, and environmental practices and dete...
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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: F3044 − 20
Standard Test Method for
Evaluating the Potential for Galvanic Corrosion for Medical
1
Implants
This standard is issued under the fixed designation F3044; 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 Warning—Mercury has been designated by many regu-
latory agencies as a hazardous substance that can cause serious
1.1 This test method covers conducting galvanic corrosion
medicalissues.Mercury,oritsvapor,hasbeendemonstratedto
tests to characterize the behavior of two dissimilar metals in
be hazardous to health and corrosive to materials. Use caution
electrical contact that are to be used in the human body as
when handling mercury and mercury-containing products. See
medical implants or as component parts to medical implants.
the applicable product Safety Data Sheet (SDS) for additional
Examples of the types of devices that might be assessed
information. The potential exists that selling mercury or
include overlapping stents of different alloys, stent and stent
mercury-containing products, or both, is prohibited by local or
marker combinations, orthopedic plates and screws where one
national law. Users must determine legality of sales in their
ormoreofthescrewsareofadifferentalloythantherestofthe
location.
device, and multi-part constructs where two or more alloys are
1.7 This standard does not purport to address all of the
used for the various component parts. Devices which are to be
safety concerns, if any, associated with its use. It is the
partially implanted, but in long-term contact within the body
responsibility of the user of this standard to establish appro-
(such as external fixation devices) may also be evaluated using
priate safety, health, and environmental practices and deter-
this method.
mine the applicability of regulatory limitations prior to use.
1.2 This test method covers the selection of specimens,
specimen preparation, test environment, method of exposure, NOTE 1—Additional information on galvanic corrosion testing and
examples of the conduct and evaluation of galvanic corrosion tests in
and method for evaluating the results to characterize the
2
electrolytes are given.
behavior of galvanic couples in an electrolyte.
1.8 This international standard was developed in accor-
1.3 Devices and device components are intended to be
dance with internationally recognized principles on standard-
tested in their finished condition, as would be implanted (that
ization established in the Decision on Principles for the
is,themetallurgicalandsurfaceconditionofthesampleshould
Development of International Standards, Guides and Recom-
be in or as close as possible to the same condition as in the
mendations issued by the World Trade Organization Technical
finished device).
Barriers to Trade (TBT) Committee.
1.4 This test method does not address other types of
corrosion and degradation damage that may occur in a device
2. Referenced Documents
such as fretting, crevices, or the effect of any galvanically
3
2.1 ASTM Standards:
induced potentials on stress corrosion and corrosion fatigue.
D1193 Specification for Reagent Water
Surface modifications, such as from scratches (possibly intro-
F2129 Test Method for Conducting Cyclic Potentiodynamic
duced during implantation) or effects of welding (during
Polarization Measurements to Determine the Corrosion
manufacture), are also not addressed. These mechanisms are
Susceptibility of Small Implant Devices
outside of the scope of this test method.
G1 Practice for Preparing, Cleaning, and Evaluating Corro-
1.5 The values stated in SI units are to be regarded as
sion Test Specimens
standard. No other units of measurement are included in this
G3 Practice for Conventions Applicable to Electrochemical
standard.
Measurements in Corrosion Testing
1 2
This test method is under the jurisdiction ofASTM Committee F04 on Medical Marek, M., “Corrosion Testing of Implantable Medical Devices,” Handbook of
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Materials for Medical Devices, Vol 23, ASM International, 2012.
3
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Aug. 15, 2020. Published August 2020. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2014. Last previous edition approved in 2014 as F3044 – 14. DOI: Standards v
...
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: F3044 − 14 F3044 − 20
Standard Test Method for
Evaluating the Potential for Galvanic Corrosion for Medical
1
Implants
This standard is issued under the fixed designation F3044; 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 covers conducting galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical
contact that are to be used in the human body as medical implants or as component parts to medical implants. Examples of the
types of devices that might be assessed include overlapping stents of different alloys, stent and stent marker combinations,
orthopedic plates and screws where one or more of the screws are of a different alloy than the rest of the device, and multi-part
constructs where two or more alloys are used for the various component parts. Devices which are to be partially implanted, but
in long-term contact within the body (such as external fixation devices) may also be evaluated using this method.
1.2 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method
for evaluating the results to characterize the behavior of galvanic couples in an electrolyte.
1.3 Devices and device components are intended to be tested in their finished condition, as would be implanted (that is, the
metallurgical and surface condition of the sample should be in or as close as possible to the same condition as in the finished
device).
1.4 This test method does not address other types of corrosion and degradation damage that may occur in a device such as fretting,
crevices, or the effect of any galvanically induced potentials on stress corrosion and corrosion fatigue. Surface modifications, such
as from scratches (possibly introduced during implantation) or effects of welding (during manufacture), are also not addressed.
These mechanisms are outside of the scope of this test method.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical
issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when
handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional
information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national
law. Users must determine legality of sales in their location.
1.7 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
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 Jan. 15, 2014Aug. 15, 2020. Published May 2014August 2020. Originally approved in 2014. Last previous edition approved in 2014 as
F3044 – 14. DOI: 10.1520/F3044-14.10.1520/F3044-20.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F3044 − 20
NOTE 1—Additional information on galvanic corrosion testing and examples of the conduct and evaluation of galvanic corrosion tests in electrolytes are
2
given in Ref. given.(1).
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:
D1193 Specification for Reagent Water
F2129 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Suscepti-
bility of Small Implant Devices
G1 Practice for Preparing, Cleaning, and Eva
...
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