ASTM_F_2820_-_12.pdf

Designation:F282012Standard Specification forPolyetherketoneketone(PEKK)Polymers for SurgicalImplant Applications1This standard is issued under the fixed designation F2820;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 virgin polyetherketoneketone(PEKK)polymer resin as supplied by a vendor(for example,inpellets,powder,and fabricated forms).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 As with any material,some characteristics may bealtered by the processing techniques(for example,molding,extrusion,machining,assembly,and sterilization)required forthe production of a specific part or device.Therefore,proper-ties of fabricated forms of these polymers should be evaluatedusing test methods which are appropriate to ensure safety andefficacy as agreed upon by the vendor,purchaser,and regulat-ing bodies.With reduced crystallinity,certain polymers havebeen shown to be more susceptible to environmental stresscracking.Depending upon the implant application,the end usershould characterize the material for environmental stress crack-ing resistance.1.3 The properties included in this specification are thoseapplicable for PEKK polymers only.Indicated properties arefor fabricated forms.Fabricated forms and materials containingcolorants,fillers,processing aids,or other additives,as well aspolymer blends which contain PEKK,or reclaimed materialsare not covered by this specification.1.4 This specification is designed to recommend physical,chemical,and biological test methods to establish a reasonablelevel of confidence concerning the performance of virginPEKK polymers for use in medical implant devices.Theproperties listed should be considered in selecting material(s)in accordance with the specific end-use requirements.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD570 Test Method for Water Absorption 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 RigidPlasticsD696 Test Method for Coefficient of Linear Thermal Expan-sion of Plastics Between 30C and 30C with a VitreousSilica DilatometerD790 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 DisplacementD955 Test Method of Measuring Shrinkage from MoldDimensions of ThermoplasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1898 Practice for Sampling of Plastics(Withdrawn 1998)31This 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 April 15,2012.Published May 2012.DOI:10.1520/F282012.2For 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 D3417 Test Method for Enthalpies of Fusion and Crystalli-zation of Polymers by Differential Scanning Calorimetry(DSC)(Withdrawn 2004)3D3418 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:4