ASTM_F_2026_-_14.pdf

Designation:F202614Standard Specification forPolyetheretherketone(PEEK)Polymers for Surgical ImplantApplications1This standard is issued under the fixed designation F2026;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers polyetheretherketone(PEEK)polymer in virgin forms as supplied by a vendor(pellets,powder,fabricated forms,and so forth).It provides require-ments and associated test methods for these thermoplasticswhen they are to be used in the manufacture of intracorporealdevices such as surgical implants or components of surgical ordental devices.1.2 The properties included in this specification are thoseapplicable for PEEK polymers only.Indicated properties arefor fabricated forms.Materials or forms containing colorants,fillers,processing aids,or other additives,as well as polymerblends which contain PEEK,or reclaimed materials,are notcovered by this specification.1.3 This specification is designed to recommend physical,chemical,and biological test methods to establish a reasonablelevel of confidence concerning the performance of virginPEEK polymers for use in medical implant devices.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 When evaluating material in accordance with thisspecification,hazardous materials,operations,and equipmentmay be involved.This standard does not purport to address allof the safety 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:2D256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise PositionD695 Test Method for Compressive Properties of RigidPlasticsD790 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 DisplacementD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD4000 Classification System for Specifying Plastic Materi-alsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standards:3ISO 178 PlasticsDetermination of Flexural PropertiesISO 180 PlasticsDetermination of Izod Impact StrengthISO 527 PlasticsDetermination of Tensile PropertiesPart 1:General PrinciplesISO 1183 PlasticsMethods for Determining the Density ofNon-cellular PlasticsPart 2:Density Gradient ColumnMethodISO 10993 Biological Evaluation of Medical Devices,Parts1-12ISO13485 MedicalDevicesQualityManagementSystemsRequirements for Regulatory Purposes2.3 Other Documents:United States Pharmacopeia,Vol.XXI,or latest edition43.Terminology3.1 Definitions of Terms Specific to This Standard:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved March 1,2014.Published May 2014.Originallyapproved in 2000.Last previous edition approved in 2012 as F2026 12.DOI:10.1520/F2026-14.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 fabricated forms,nthose items into which the virginforms may be converted.These include shapes and formsproduced by means of machining,extruding,and compressionmolding virgin forms into a subsequent entity(for example,fibers,tubes,rods,slabs,sheets,film,or complex shaped partsand devices).3.1.2 formulated compound,nmaterials,parts,or devicesfabricated from virgin forms in such a way as to containintentional or unintentional adjuvant substances.3.1.3 virgin forms,nthe initially delivered form of thepolymer as synthesized from its monomers prior to anyprocessing or fabrication into a medical device.The providedresin is typically in the form of pellets,granules,or p