ASTM F3268-18a
(Guide)Standard Guide for in vitro Degradation Testing of Absorbable Metals
Standard Guide for <emph type="bdit">in vitro</emph> Degradation Testing of Absorbable Metals
SIGNIFICANCE AND USE
5.1 This standard provides an itemization of potential in vitro test methods to evaluate the degradation of absorbable metals. The provided approach defers to the user of this standard to pick most appropriate method(s) based on the specific requirements of the intended application. However, a minimum of at least two different corrosion evaluation methods is considered necessary for basic profiling of the material or device, with additional methods potentially needed for an adequate characterization. However, in some instances there may be only one method that correlates to in vivo degradation results.
5.2 It is recognized that not all test methods will be meaningful for every situation. In addition, some methods carry different potential than others regarding their relative approximation to the in vivo conditions within which actual use is to occur. As a result, some discussion and ranking of the relevance of the described methods is provided by this guidance.
5.3 It should be noted that degradation of absorbable metals is not linear. Thus, precautions should be taken that evaluations of the degradation profile of a metal or metal device are appropriately adapted to reflect the varying stages and rates of degradation. Relevant factors can include the amount or percentage (%) of tissue coverage of the implanted device and the metabolic rate of surrounding tissue, which is not necessarily accompanied by a high perfusion rate.
5.4 It is recognized that in vivo environments will impart specialized considerations that can directly affect the corrosion rate, even when compared with other in vivo locations. Thus, a basic understanding of the biochemistry and physiology of the specific targeted implant location (e.g. hard tissue; soft tissue; high, low or zero perfusion areas/tissue; high, low or zero loading environments) is needed to optimize in vitro and in vivo evaluations.
5.5 Within the evaluation of absorbable metals, rate uniformity is considered to be ...
SCOPE
1.1 The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy.
1.2 The described experimental approaches are intended to control the corrosion test environment through standardization of conditions and utilization of physiologically relevant electrolyte fluids. Evaluation of a standardized degradation control material is also incorporated to facilitate comparison and normalization of results across laboratories.
1.3 The obtained test results may be used to screen materials and/or constructs prior to evaluation of a more refined fabricated device. The described tests may also be utilized to define a device’s performance threshold prior to more extensive in vitro performance evaluations (e.g. fatigue testing) or in vivo evaluations.
1.4 This standard is considered to be applicable to all absorbable metals, including magnesium, iron, and zinc-based metals and alloys.
1.5 The described tests are not considered to be representative of in vivo conditions and could potentially provide a more rapid or slower degradation rate than an absorbable metal’s actual in vivo corrosion rate. The herein described test methods are to be used for material comparison purposes only and are not to act as either a predictor or substitute for evaluation of the in vivo degradation properties of a device.
1.6 This standard only provides guidance regarding the in vitro degradation of absorbable metals and does not address any aspect regarding either in vivo or biocompatibility evaluations.
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 determine the applicability of regulatory limit...
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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: F3268 − 18a
Standard Guide for
1
in vitro Degradation Testing of Absorbable Metals
This standard is issued under the fixed designation F3268; 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 1.8 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 The purpose of this standard is to outline appropriate
ization established in the Decision on Principles for the
experimentalapproachesforconductinganinitialevaluationof
Development of International Standards, Guides and Recom-
the in vitro degradation properties of a device or test sample
mendations issued by the World Trade Organization Technical
fabricated from an absorbable metal or alloy.
Barriers to Trade (TBT) Committee.
1.2 The described experimental approaches are intended to
control the corrosion test environment through standardization
2. Referenced Documents
of conditions and utilization of physiologically relevant elec-
2
2.1 ASTM Standards:
trolyte fluids. Evaluation of a standardized degradation control
B943 Specification for Zinc and Tin Alloy Wire Used in
material is also incorporated to facilitate comparison and
Thermal Spraying for Electronic Applications
normalization of results across laboratories.
B954 Test Method for Analysis of Magnesium and Magne-
1.3 Theobtainedtestresultsmaybeusedtoscreenmaterials
sium Alloys by Atomic Emission Spectrometry
and/or constructs prior to evaluation of a more refined fabri-
E2375 Practice for Ultrasonic Testing of Wrought Products
cated device. The described tests may also be utilized to define
F1854 Test Method for Stereological Evaluation of Porous
a device’s performance threshold prior to more extensive in
Coatings on Medical Implants
vitro performance evaluations (e.g. fatigue testing) or in vivo
F2129 Test Method for Conducting Cyclic Potentiodynamic
evaluations.
Polarization Measurements to Determine the Corrosion
Susceptibility of Small Implant Devices
1.4 This standard is considered to be applicable to all
F2739 Guide for Quantifying Cell Viability and Related
absorbable metals, including magnesium, iron, and zinc-based
Attributes within Biomaterial Scaffolds
metals and alloys.
F3160 Guide for Metallurgical Characterization of Absorb-
1.5 The described tests are not considered to be representa-
able Metallic Materials for Medical Implants
tive of in vivo conditions and could potentially provide a more
G1 Practice for Preparing, Cleaning, and Evaluating Corro-
rapid or slower degradation rate than an absorbable metal’s
sion Test Specimens
actual in vivo corrosion rate.The herein described test methods
G3 Practice for Conventions Applicable to Electrochemical
are to be used for material comparison purposes only and are
Measurements in Corrosion Testing
nottoactaseitherapredictororsubstituteforevaluationofthe
G4 Guide for Conducting Corrosion Tests in Field Applica-
in vivo degradation properties of a device.
tions
1.6 This standard only provides guidance regarding the in
G16 Guide for Applying Statistics to Analysis of Corrosion
vitro degradation of absorbable metals and does not address
Data
any aspect regarding either in vivo or biocompatibility evalu-
G31 Guide for Laboratory Immersion Corrosion Testing of
ations.
Metals
G46 Guide for Examination and Evaluation of Pitting Cor-
1.7 This standard does not purport to address all of the
rosion
safety concerns, if any, associated with its use. It is the
G59 Test Method for Conducting Potentiodynamic Polariza-
responsibility of the user of this standard to establish appro-
tion Resistance Measurements
priate safety, health, and environmental practices and deter-
G102 Practice for Calculation of Corrosion Rates and Re-
mine the applicability of regulatory limitations prior to use.
lated Information from Electrochemical Measurements
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2018. Published November 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2018. Last previous edition approved in 2018 as F3268–18. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3268-18A. the AST
...
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: F3268 − 18 F3268 − 18a
Standard Guide for
1
in vitro Degradation Testing of Absorbable Metals
This standard is issued under the fixed designation F3268; 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 The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the
in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy.
1.2 The described experimental approaches are intended to control the corrosion test environment through standardization of
conditions and utilization of physiologically relevant electrolyte fluids. Evaluation of a standardized degradation control material
is also incorporated to facilitate comparison and normalization of results across laboratories.
1.3 The obtained test results may be used to screen materials and/or constructs prior to evaluation of a more refined fabricated
device. The described tests may also be utilized to define a device’s performance threshold prior to more extensive in vitro
performance evaluations (e.g. fatigue testing) or in vivo evaluations.
1.4 This standard is considered to be applicable to all absorbable metals, including magnesium, iron, and zinc-based metals and
alloys.
1.5 The described tests are not considered to be representative of in vivo conditions and could potentially provide a more rapid
or slower degradation rate than an absorbable metal’s actual in vivo corrosion rate. The herein described test methods are to be
used for material comparison purposes only and are not to act as either a predictor or substitute for evaluation of the in vivo
degradation properties of a device.
1.6 This standard only provides guidance regarding the in vitro degradation of absorbable metals and does not address any
aspect regarding either in vivo or biocompatibility evaluations.
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 determine the applicability of
regulatory limitations prior to use.
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
2
2.1 ASTM Standards:
B943 Specification for Zinc and Tin Alloy Wire Used in Thermal Spraying for Electronic Applications
B954 Test Method for Analysis of Magnesium and Magnesium Alloys by Atomic Emission Spectrometry
E2375 Practice for Ultrasonic Testing of Wrought Products
F1854 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F2129 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Suscepti-
bility of Small Implant Devices
F2739 Guide for Quantifying Cell Viability within Biomaterial Scaffolds
F3160 Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
G1 Practice for Preparing, Cleaning, and Evaluating Corrosion Test Specimens
G3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
1
This guide 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 April 1, 2018Oct. 1, 2018. Published May 2018November 2018. Originally approved in 2018. Last previous edition approved in 2018 as
F3268–18. DOI: 10.1520/F3268-18.vb h10.1520/F3268-18A.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F3268 − 18a
G4 Guide for Conducting Corrosion Tests in Field Applications
G16 Guide for Applying Statist
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