ASTM_F_1876_-_98_2003e1.pdf

Designation:F 1876 98(Reapproved 2003)e1Standard Specification forPolyetherketoneetherketoneketone(PEKEKK)Resins forSurgical Implant Applications1This standard is issued under the fixed designation F 1876;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(e)indicates an editorial change since the last revision or reapproval.e1NOTETable 2 was editorially corrected in June 2003.1.Scope1.1 This specification covers polyetherketoneetherketoneke-tone(PEKEKK)resins in virgin forms as supplied by a vendor,such as flakes,pellets,blocks,and so forth.It providesrequirements and associated test methods for these thermoplas-tics when they are to be used in the manufacturing ofintracorporeal devices,such as surgical implants or compo-nents of surgical or dental devices.1.2 As with any material,some characteristics may bealtered by the processing techniques,such as molding,extru-sion,machining,assembly,sterilization,and so forth requiredfor the production of a specific part or device;therefore,properties of fabricated forms of these resins should beevaluated using test methods that are appropriate to assuresafety and efficacy as agreed upon by the vendor,purchaser,and regulating bodies.1.3 The properties included in this specification are thoseapplicable for PEKEKK resins only.Fabricated forms,materialor forms containing colorants,fillers,processing aids,or otheradditives,as well as polymer blends that contain PEKEKK,arenot 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 virginPEKEKK resins for use in medical devices.The propertieslisted should be considered in selecting material according tothe specific end-use requirements.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:D 149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power Frequencies2D 256 Test Methods for Determining the Izod PendulumImpact Resistance of Plastics3D 570 Test Method for Water Absorption of Plastics3D 638 Test Method for Tensile Properties of Plastics3D 648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise Position3D 695 Test Method for Compressive Properties of RigidPlastics3D 696 Test Method for Coefficient of Linear Thermal Ex-pansion of Plastics Between 30C and 30C with aVitreous Silica Dilatometer3D 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-als3D 792 Test Methods for Relative Density,Density of Plas-tics and Specific Gravity by Displacement3D 955 Test Method for Measuring Shrinkage from MoldDimensions of Molded Plastics3D 1238 Test Method for Flow Rates of Thermoplastics byExtrusion Plastometer3D 1505 Test Method for Density of Plastics by the Density-Gradient Technique3D 1898 Practice for Sampling of Plastics4D 3417 Test Method for Enthalpies of Fusion and Crystal-lization of Polymers by Differential Scanning Calorimetry(DSC)5D 3418 Test Methods for Transition Temperatures of Poly-mers by Differential Scanning Calorimetry(DSC)5D 4000 Classification System for Specifying Plastic Mate-rials5F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices61This 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 Apr.10,2003.Published June 2003.Originallyapproved in 1998.Last previous edition approved in 1998 as F 1876 98.2Annual Book of ASTM Standards,Vol 10.01.3Annual Book of ASTM Standards,Vol 08.01.4Discontinued;See 1997 Annual Book of ASTM Standards,Vol 08.01.5Annual Book of ASTM Standards,Vol 08.02.6Annual Book of ASTM Standards,Vol 13.01.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.2.2ISO Standards:ISO 1628/1 PlasticsGuidelines for the Standardization ofMethods for Determination of Viscosity Number andLimiting Viscosity Number of Polymers in Dilute Solu-tionPart 1:General Conditions6ISO 1133 PlasticsDetermination of the Melt Mass-FlowRate(MFR)and the Melt Volume-Flow Rate(MVR)ofThermoplastics6ISO 10993 Biological Evaluation of Medical Devices,Parts11272.3Other Documents:FDA Regulation CFR 177.15808United States Pharmacopeia,Vol XXI,or latest edition93.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 fabricated for