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ASTM F3044-14

(Test Method)

Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

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

General Information

Status
Historical
Publication Date
14-Jan-2014
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Referred By
ASTM G215-17 - Standard Guide for Electrode Potential Measurement
Effective Date
15-Jan-2014
Referred By
ASTM F3306-19 - Standard Test Method for Ion Release Evaluation of Medical Implants
Effective Date
15-Jan-2014

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ASTM F3044-14 - Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical ImplantsASTM F3044-14 - Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
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ASTM F3044-14 - Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3044 − 14
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.
NOTE 1—Additional information on galvanic corrosion testing and
1. Scope
examples of the conduct and evaluation of galvanic corrosion tests in
2
1.1 This test method covers conducting galvanic corrosion
electrolytes are given in Ref. (1).
tests to characterize the behavior of two dissimilar metals in
1.6 This international standard was developed in accor-
electrical contact that are to be used in the human body as
dance with internationally recognized principles on standard-
medical implants or as component parts to medical implants.
ization established in the Decision on Principles for the
Examples of the types of devices that might be assessed
Development of International Standards, Guides and Recom-
include overlapping stents of different alloys, stent and stent
mendations issued by the World Trade Organization Technical
marker combinations, orthopedic plates and screws where one
Barriers to Trade (TBT) Committee.
ormoreofthescrewsareofadifferentalloythantherestofthe
device, and multi-part constructs where two or more alloys are
2. Referenced Documents
used for the various component parts. Devices which are to be
3
2.1 ASTM Standards:
partially implanted, but in long-term contact within the body
D1193 Specification for Reagent Water
(such as external fixation devices) may also be evaluated using
F2129 Test Method for Conducting Cyclic Potentiodynamic
this method.
Polarization Measurements to Determine the Corrosion
1.2 This test method covers the selection of specimens,
Susceptibility of Small Implant Devices
specimen preparation, test environment, method of exposure,
G1 Practice for Preparing, Cleaning, and Evaluating Corro-
and method for evaluating the results to characterize the
sion Test Specimens
behavior of galvanic couples in an electrolyte.
G3 Practice for Conventions Applicable to Electrochemical
1.3 Devices and device components are intended to be Measurements in Corrosion Testing
tested in their finished condition, as would be implanted (that
G5 Reference Test Method for Making Potentiodynamic
is,themetallurgicalandsurfaceconditionofthesampleshould
Anodic Polarization Measurements
be in or as close as possible to the same condition as in the
G15 Terminology Relating to Corrosion and Corrosion Test-
4
finished device).
ing (Withdrawn 2010)
G16 Guide for Applying Statistics to Analysis of Corrosion
1.4 This test method does not address other types of
Data
corrosion and degradation damage that may occur in a device
G31 Guide for Laboratory Immersion Corrosion Testing of
such as fretting, crevices, or the effect of any galvanically
Metals
induced potentials on stress corrosion and corrosion fatigue.
G46 Guide for Examination and Evaluation of Pitting Cor-
Surface modifications, such as from scratches (possibly intro-
rosion
duced during implantation) or effects of welding (during
G59 Test Method for Conducting Potentiodynamic Polariza-
manufacture), are also not addressed. These mechanisms are
tion Resistance Measurements
outside of the scope of this test method.
G71 Guide for Conducting and Evaluating Galvanic Corro-
1.5 This standard does not purport to address all of the
sion Tests in Electrolytes
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
2
The boldface number in parentheses refers to the reference provided at the end
bility of regulatory limitations prior to use.
of the document.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.15 on Material Test Methods. the ASTM website.
4
Current edition approved Jan. 15, 2014. Published May 2014. DOI: 10.1520/ The last approved version of this historical standard is referenced on
F3044-14. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3044 − 14
G82 Guide for Development and Use of a Galvanic Series used (for example
...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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Standard Specification and Test Methods for Metallic Medical Bone Screws

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A1.1 Significance and Use
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1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off