ASTM_F_624_-_09_2015e1.pdf

Designation:F62409(Reapproved 2015)1Standard Guide forEvaluation of Thermoplastic Polyurethane Solids andSolutions for Biomedical Applications1This standard is issued under the fixed designation F624;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1NOTESection 1.2 was editorially corrected in May 2015.1.Scope1.1 This guide covers the evaluation of thermoplastic poly-urethanes in both solid and solution form for biomedicalapplications.The polymers have been reacted to completionand require no further chemical processing.1.2 The tests and methods listed in this guide may bereferenced in specifications containing minimum requiredvalues and tolerances for specific end-use products.1.3 Standard tests for biocompatibility are included to aid inthe assessment of safe utilization in biomedical applications.Compliance with these criteria shall not be construed as anendorsement of implantability.Since many compositions,formulations,and forms of thermoplastic polyurethanes insolid and solution forms are within this material class,theformulator or fabricator must evaluate the biocompatibility ofthe specific composition or form in the intended use and aftercompletion of all manufacturing processes including steriliza-tion.1.4 Purchase specifications may be prepared by agreementbetween the buyer and seller by selection of appropriate testsand methods from those listed applicable to the specificbiomedical end use.1.5 This standard 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 and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD150 Test Methods for AC Loss Characteristics and Permit-tivity(Dielectric Constant)of Solid Electrical InsulationD257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD395 Test Methods for Rubber PropertyCompression SetD412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD570 Test Method for Water Absorption of PlasticsD575 Test Methods for Rubber Properties in CompressionD671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force(Withdrawn 2002)3D790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1242 Test Methods for Resistance of Plastic Materials toAbrasion(Withdrawn 2003)3D1434 Test Method for Determining Gas Permeability Char-acteristics of Plastic Film and SheetingD1544 Test Method for Color of Transparent Liquids(Gard-ner Color Scale)D1638 Methods of Testing Urethane Foam Isocyanate RawMaterials(Withdrawn 1989)3D2124 Test Method for Analysis of Components in Poly(Vi-nyl Chloride)Compounds Using an Infrared Spectropho-tometric TechniqueD2240 Test Method for Rubber PropertyDurometer Hard-nessD2857 Practice for Dilute Solution Viscosity of PolymersD2990 Test Methods for Tensile,Compressive,and FlexuralCreep and Creep-Rupture of Plastics1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved March 1,2015.Published May 2015.Originallyapproved in 1981.Last previous edition approved in 2009 as F624 09.DOI:10.1520/F0624-09R15E01.2For 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 page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 D3137 Test Method for Rubber PropertyHydrolytic Sta-bilityD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryE96/E96M Test Methods for Water Vapor Transmission ofMaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices43.Terminology3.1 Definitions:3.1.1 chain extender(1)an active hydrogen containing acompound such as a diol or diamine used to increase themolecular weight of an isocyanate-terminated prepolymer bychemical reaction;(2)a di