ASTM F2129-19a
(Test Method)Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
SIGNIFICANCE AND USE
5.1 Corrosion of implantable medical devices can have deleterious effects on the device performance or may result in the release of corrosion products with harmful biological consequences; therefore it is important to determine the general corrosion behavior as well as the susceptibility of the devices to localized corrosion.
5.2 The forming and finishing steps used to create an implantable device may have significant effects on the corrosion resistance of the material out of which the device is fabricated. During the selection process of a material for use as an implantable device, testing the corrosion resistance of the material is an essential step; however, it does not necessarily provide critical data regarding device performance.
5.3 To accommodate the wide variety of device shapes and sizes encountered, a variety of holding devices can be used.
5.4 Note that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown and deterioration of the medical devices and that these conditions may not necessarily be encountered in vivo. The results of this corrosion test conducted in artificial physiological electrolytes can provide useful data for comparison of different device materials, designs, or manufacturing processes. However, note that this test method does not take into account the effects of cells, proteins, and so forth, on the corrosion behavior in vivo.
SCOPE
1.1 This test method assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents (Specification F1828), filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.
1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus (see Section 6). It is assumed that test methods, such as Reference Test Method G5 and Test Method G61 have been used for material screening.
1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations.
1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion.
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 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 determine the applicability of regulatory limitations prior to use.
1.7 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.
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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: F2129 − 19a
Standard Test Method for
Conducting Cyclic Potentiodynamic Polarization
Measurements to Determine the Corrosion Susceptibility of
1
Small Implant Devices
This standard is issued under the fixed designation F2129; 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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This test method assesses the corrosion susceptibility of
Barriers to Trade (TBT) Committee.
small, metallic, implant medical devices, or components
thereof, using cyclic (forward and reverse) potentiodynamic
2. Referenced Documents
polarization. Examples of device types that may be evaluated
2
by this test method include, but are not limited to, vascular 2.1 ASTM Standards:
D1193 Specification for Reagent Water
stents, ureteral stents (Specification F1828), filters, support
E177 Practice for Use of the Terms Precision and Bias in
segments of endovascular grafts, cardiac occluders, aneurysm
ASTM Test Methods
or ligation clips, staples, and so forth.
E691 Practice for Conducting an Interlaboratory Study to
1.2 This test method is used to assess a device in its final
Determine the Precision of a Test Method
form and finish, as it would be implanted. These small devices
F1828 Specification for Ureteral Stents
shouldbetestedintheirentirety.Theupperlimitondevicesize
G3 Practice for Conventions Applicable to Electrochemical
is dictated by the electrical current delivery capability of the
Measurements in Corrosion Testing
test apparatus (see Section 6). It is assumed that test methods,
G5 Reference Test Method for Making Potentiodynamic
such as Reference Test Method G5 and Test Method G61 have
Anodic Polarization Measurements
been used for material screening.
G15 Terminology Relating to Corrosion and Corrosion Test-
3
1.3 Because of the variety of configurations and sizes of
ing (Withdrawn 2010)
implants, this test method provides a variety of specimen
G61 Test Method for Conducting Cyclic Potentiodynamic
holder configurations.
Polarization Measurements for Localized Corrosion Sus-
ceptibility of Iron-, Nickel-, or Cobalt-Based Alloys
1.4 This test method is intended for use on implantable
G215 Guide for Electrode Potential Measurement
devices made from metals with a relatively high resistance to
corrosion.
3. Terminology
1.5 The values stated in SI units are to be regarded as
3.1 Definitions:
standard. No other units of measurement are included in this
3.1.1 potentiodynamic cyclic polarization (forward and re-
standard.
verse polarization), n—a technique in which the potential of
1.6 This standard does not purport to address all of the
the test specimen is controlled and the corrosion current
safety concerns, if any, associated with its use. It is the
measured by a potentiostat. The potential is scanned in the
responsibility of the user of this standard to establish appro-
positive or noble (forward) direction as defined in Practice G3.
priate safety, health, and environmental practices and deter-
The potential scan is continued until a predetermined potential
mine the applicability of regulatory limitations prior to use.
or current density is reached.Typically, the scan is run until the
1.7 This international standard was developed in accor-
transpassive region is reached, and the specimen no longer
dance with internationally recognized principles on standard-
demonstratespassivity,asdefinedinPracticeG3.Thepotential
ization established in the Decision on Principles for the
1 2
This test method is under the jurisdiction ofASTM Committee F04 on Medical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
and Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 15, 2019. Published March 2019. Originally the ASTM website.
3
approved in 2001. Last previous edition approved in 2019 as F2129–19. DOI: The last approved version of this historical standard is referenced on
10.1520/F2129–19A. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2129 − 19a
scan directio
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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: F2129 − 19 F2129 − 19a
Standard Test Method for
Conducting Cyclic Potentiodynamic Polarization
Measurements to Determine the Corrosion Susceptibility of
1
Small Implant Devices
This standard is issued under the fixed designation F2129; 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 assesses the corrosion susceptibility of small, metallic, implant medical devices, or components thereof,
using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test
method include, but are not limited to, vascular stents, ureteral stents (Specification F1828), filters, support segments of
endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.
1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should
be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus
(see Section 6). It is assumed that test methods, such as Reference Test Method G5 and Test Method G61 have been used for
material screening.
1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder
configurations.
1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion.
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 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 determine the applicability of
regulatory limitations prior to use.
1.7 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
2
2.1 ASTM Standards:
D1193 Specification for Reagent Water
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F1828 Specification for Ureteral Stents
G3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
G5 Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
3
G15 Terminology Relating to Corrosion and Corrosion Testing (Withdrawn 2010)
G61 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility of
Iron-, Nickel-, or Cobalt-Based Alloys
G215 Guide for Electrode Potential Measurement
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. 1, 2019Jan. 15, 2019. Published March 2019. Originally approved in 2001. Last previous edition approved in 20172019 as F2129–17b.–19.
DOI: 10.1520/F2129–19.10.1520/F2129–19A.
2
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 on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2129 − 19a
3. Terminology
3.1 Definitions:
3.1.1 potentiodynamic cyclic polarization (forward and reverse polarization), n—a technique in which the potential of the test
specimen is controlled and the corrosion current measured by a potentiostat. The potential is scanned in the positive or noble
(forward) direction as defined in Practice G3. The potential scan is continued until a predetermined potential or current density is
reache
...
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