ASTM F2129-08

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2129–06 Designation:F2129–08
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 F 2129; 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 F 1828), 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
betestedintheirentirety.Theupperlimitondevicesizeisdictatedbytheelectricalcurrentdeliverycapabilityofthetestapparatus
(see Section 6). It is assumed that test methods, such as Reference Test Method G 5 and Test Method G 61 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
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1193 Specification for Reagent Water
E 177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E 691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F 1828 Specification for Ureteral Stents
G3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
G5 Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements
G15 Terminology Relating to Corrosion and Corrosion Testing
G61 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility
of Iron-, Nickel-, or Cobalt-Based Alloys
3. Terminology
3.1 Definitions:
3.1.1 potentiostat, n—an instrument for automatically maintaining an electrode in an electrolyte at a constant potential or
controlled potentials with respect to a suitable reference electrode (see Terminology G 15).
3.1.2 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 G 3. The potential scan is continued until a predetermined potential or current density
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 May 15, 2006. Published May 2006. Originally approved in 2001. Last previous edition approved in 2004 as F2129–04.
Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 2001. Last previous edition approved in 2006 as F 2129 – 06.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.ForAnnualBookofASTMStandards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2129–08
is reached. Typically, the scan is run until the transpassive region is reached, and the specimen no longer demonstrates passivity,
as defined in Practice G 3. The potential scan direction then is reversed until
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2129–06 Designation:F2129–08
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 F 2129; 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 F 1828), 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
betestedintheirentirety.Theupperlimitondevicesizeisdictatedbytheelectricalcurrentdeliverycapabilityofthetestapparatus
(see Section 6). It is assumed that test methods, such as Reference Test Method G 5 and Test Method G 61 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
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D 1193 Specification for Reagent Water
E 177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E 691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F 1828 Specification for Ureteral Stents
G 3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
G 5 Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements
G 15 Terminology Relating to Corrosion and Corrosion Testing
G 61 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility
of Iron-, Nickel-, or Cobalt-Based Alloys
3. Terminology
3.1 Definitions:
3.1.1 potentiostat, n—an instrument for automatically maintaining an electrode in an electrolyte at a constant potential or
controlled potentials with respect to a suitable reference electrode (see Terminology G 15).
3.1.2 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 G 3. The potential scan is continued until a predetermined potential or current density
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 May 15, 2006. Published May 2006. Originally approved in 2001. Last previous edition approved in 2004 as F2129–04.
Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 2001. Last previous edition approved in 2006 as F 2129 – 06.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.ForAnnualBookofASTMStandards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2129–08
is reached. Typically, the scan is run until the transpassive region is reached, and the specimen no longer demonstrates passivity,
as defined in Practice G 3. The potential scan direction then is reversed u
...