ASTM_F_1579_-_02e1.pdf

Designation:F 1579 02e1Standard Specification forPolyaryletherketone(PAEK)Polymers for Surgical ImplantApplications1This standard is issued under the fixed designation F 1579;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.e1NOTEEditorial changes were made throughout in June 2003.1.Scope1.1 This specification covers polyaryletherketone(PAEK)polymers in virgin forms as supplied by a vendor(pellets,powder,and so forth).It provides requirements and associatedtest methods for these thermoplastics when they are to be usedin the manufacture of intracorporeal devices such as surgicalimplants or components of surgical or dental devices.1.2 As with any material,some characteristics may bealtered by the processing techniques(molding,extrusion,machining,assembly,sterilization,and so forth)required forthe production of a specific part or device.Therefore,proper-ties of fabricated forms of these polymers should be evaluatedusing test methods that are appropriate to ensure safety andefficacy as agreed upon by the vendor,purchaser,and regulat-ing bodies.1.3 The properties included in this specification are thoseapplicable for PAEK polymers only.Fabricated forms,materialor forms containing colorants,fillers,processing aids,or otheradditives,as well as polymer blends that contain PAEK,are notcovered 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 unfilledPAEK polymers for use in medical devices.The propertieslisted should be considered in selecting material according tothe specific end-use requirements.1.5 When evaluating material to this specification hazardousmaterials,operations,and equipment may be involved.Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.Referenced Documents2.1 ASTM Standards:D 149 Test Methods for Dielectric Breakdown Voltage andDielectric Strength of Electrical Insulating Materials atCommercial Power Frequencies2D 256 Test Methods for Determining the Izod PendulumImpact Resistance of Plastics3D 570 Test Method for Water Absorption of Plastics3D 621 Test Methods for Deformation of Plastics UnderLoad4D 638 Test Method for Tensile Properties of Plastics3D 648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load3D 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 Specific Gravity(Relative Density)and Density of Plastics by Displacement3D 955 Test Method for Measuring Shrinkage from MoldDimensions of Thermoplastics3D 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 Plastics5D 3417 Test Method for Heats of Fusion and Crystallizationof Polymers by Differential Scanning Calorimeter(DSC)6D 3418 Test Methods for Transition Temperatures of Poly-mers by Differential Scanning Calorimeter(DSC)61This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is under the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Apr.10,2002.Published June 2002.Originallypublished as F 1579 95.Last previous edition F 1579 98.2Annual Book of ASTM Standards,Vol 10.01.3Annual Book of ASTM Standards,Vol 08.01.4Discontinued;see 1993 Annual Book of ASTM Standards,Vol 08.01.5Discontinued;see 1997 Annual Book of ASTM Standards,Vol 08.02.6Annual Book of ASTM Standards,Vol 08.03.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.D 4000 Classification System for Specifying Plastic Mate-rials6F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices7F 1876 Specification for Polyetherketoneetherketoneketone(PEKEKK)Resins for Surgical Implant Applications7F 2026 Specification for Polyetheretherketone(PEEK)Polymers for Surgical Implant Applications72.2ISO Documents:ISO 1133 PlasticsDetermination of the Melt Mass-FlowRate(MFR)and the Melt Volume-Flow Rate(MVR)ofThermoplastics8ISO 1628/1 Plastics,Guidelines for the Standardization ofMethods for Determination of Viscosity Number andLimiting Viscosity Number of Polymers in DiluteSolut