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ASTM F 3044 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
Available format(s)

Hardcopy , PDF

Superseded date

03-09-2020

Language(s)

English

Published date

15-01-2014

CONTAINED IN VOL. 13.02, 2017 Defines 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.

1.1This 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.

1.2This 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.

1.3Devices 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).

1.4This 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.

1.5This 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.

Note 1Additional information on galvanic corrosion testing and examples of the conduct and evaluation of galvanic corrosion tests in electrolytes are given in Ref. (1).2

Committee
F 04
DocumentType
Test Method
Pages
7
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM G 215 : 2017 : REDLINE Standard Guide for Electrode Potential Measurement
ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ASTM G 215 : 2017 Standard Guide for Electrode Potential Measurement
ASTM F 3306 : 2019 Standard Test Method for Ion Release Evaluation of Medical Implants
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

ASTM F 2129 : 2008 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F 2129 : 2003 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM G 59 : 1997 Standard Test Method for Conducting Potentiodynamic Polarization Resistance Measurements
ASTM F 2129 : 2004 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM D 1193 : 1977 : R1983 : EDT 1 Standard Specification for Reagent Water
ASTM F 2129 : 2015 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F 2129 : 2006 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM D 1193 : 2006 : R2011 Standard Specification for Reagent Water
ASTM F 2129 : 2017 : REV B Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F 2129 : 2001 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F 2129 : 2019 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F 2129 : 2017 : REV A Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM D 1193 : 1991 Standard Specification for Reagent Water
ASTM F 2129 : 2019 : REV A Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM G 46 : 1994 : R2018 Standard Guide for Examination and Evaluation of Pitting Corrosion
ASTM F 2129 : 2017 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM D 1193 : 1970 Standard Specification For Reagent Water
ASTM D 1193 : 2006 Standard Specification for Reagent Water
ASTM D 1193 : 1999 Standard Specification for Reagent Water
ASTM G 3 : 2014 Standard Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
ASTM D 1193 : 2006 : R2018 Standard Specification for Reagent Water

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