ASTM F3268-2018 Standard Guide for in vitro Degradation Testing of Absorbable Metals.pdf
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1、Designation: F3268 18Standard Guide forin vitro Degradation Testing of Absorbable Metals1This standard is issued under the fixed designation F3268; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number
2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 The purpose of this standard is to outline appropriateexperimental approaches for conducting an initial evaluation ofthe in vitro degradation
3、 properties of a device or test samplefabricated from an absorbable metal or alloy.1.2 The described experimental approaches are intended tocontrol the corrosion test environment through standardizationof conditions and utilization of physiologically relevant elec-trolyte fluids. Evaluation of a sta
4、ndardized degradation controlmaterial is also incorporated to facilitate comparison andnormalization of results across laboratories.1.3 The obtained test results may be used to screen materialsand/or constructs prior to evaluation of a more refined fabri-cated device. The described tests may also be
5、 utilized to definea devices performance threshold prior to more extensive invitro performance evaluations (e.g. fatigue testing) or in vivoevaluations.1.4 This standard is considered to be applicable to allabsorbable metals, including magnesium, iron, and zinc-basedmetals and alloys.1.5 The describ
6、ed tests are not considered to be representa-tive of in vivo conditions and could potentially provide a morerapid or slower degradation rate than an absorbable metalsactual in vivo corrosion rate. The herein described test methodsare to be used for material comparison purposes only and arenot to act
7、 as either a predictor or substitute for evaluation of thein vivo degradation properties of a device.1.6 This standard only provides guidance regarding the invitro degradation of absorbable metals and does not addressany aspect regarding either in vivo or biocompatibility evalu-ations.1.7 This stand
8、ard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.8 This inte
9、rnational standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT)
10、Committee.2. Referenced Documents2.1 ASTM Standards:2B943 Specification for Zinc and Tin Alloy Wire Used inThermal Spraying for Electronic ApplicationsB954 Test Method for Analysis of Magnesium and Magne-sium Alloys by Atomic Emission SpectrometryE2375 Practice for Ultrasonic Testing of Wrought Prod
11、uctsF1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF2129 Test Method for Conducting Cyclic PotentiodynamicPolarization Measurements to Determine the CorrosionSusceptibility of Small Implant DevicesF2739 Guide for Quantifying Cell Viability within Bioma-terial Sca
12、ffoldsF3160 Guide for Metallurgical Characterization of Absorb-able Metallic Materials for Medical ImplantsG1 Practice for Preparing, Cleaning, and Evaluating Corro-sion Test SpecimensG3 Practice for Conventions Applicable to ElectrochemicalMeasurements in Corrosion TestingG4 Guide for Conducting Co
13、rrosion Tests in Field Applica-tionsG16 Guide for Applying Statistics to Analysis of CorrosionDataG31 Guide for Laboratory Immersion Corrosion Testing ofMetalsG46 Guide for Examination and Evaluation of Pitting Cor-rosionG59 Test Method for Conducting Potentiodynamic Polariza-tion Resistance Measure
14、mentsG102 Practice for Calculation of Corrosion Rates and Re-lated Information from Electrochemical Measurements1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Cur
15、rent edition approved April 1, 2018. Published May 2018. DOI: 10.1520/F3268-18.vb h2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary pa
16、ge onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for t
17、heDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1G106 Practice for Verification of Algorithm and Equipmentfor Electrochemical Impedance Measurements2.2 DIN Standards:3DIN 50918 Elektrochemische Ko
18、rrosionsuntersuchungen.Deutsche Normen. Berlin: Beuth Verlag; 1978. p. 1-62.3 ISO Standards:4ISO 10993-15 Biological evaluation of medical devices Part15: Identification and quantification of degradation prod-ucts from metals and alloysISO 13485 Medical devices Quality management systems Requirement
19、s for regulatory purposes3. Terminology3.1 Definitions:3.1.1 absorbable, adjin the body, referring to an initiallydistinct foreign material or substance that either directly orthrough intended degradation can be excreted, metabolized orassimilated by cells and/or tissue.3.1.2 surface roughness, RA,n
20、the arithmetic average de-viation of the surface profile from the centerline, normallyreported in micrometers.3.2 Definitions of Terms Specific to This Standard:3.2.1 degradation, nthe breakdown of a metallic testmaterial or metallic device principally due to corrosion in anelectrolyte solution rele
21、vant to physiologic conditions.3.2.2 degradation control material, nmultiple batches of adefined metallic compositon with sufficiently uniform corro-sion properties to verify an experimental setup and to comparerelative intra-laboratory and/or inter-laboratory corrosion rates.4. Summary of Guide4.1
22、Guidance is given on in vitro evaluation of thecorrosion/degradation properties of absorbable metal materialsand devices fabricated from absorbable metals. Considerationsspecific to the application of corrosion testing methods toabsorbable metal materials are outlined for both immersion andelectroch
23、emical methods.4.1.1 Electrolyte composition is a critical factor in corrosionexperiments. Several electrolytes are commonly used to mimicin vivo conditions. Electrolyte selection may also take intoconsideration the alloy being tested.4.1.2 Control of the experimental conditions (i.e.,temperature, p
24、H and fluid movement around the test piece(s)can markedly affect the corrosion rates and experimentaloutcomes. Controlling and documenting these factors areimportant with regard to generating consistent, reproducibleresults. Experimental conditions may be altered, depending onthe intent of the exper
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