ASTM_F_702_-_10.pdf

Designation:F70210Standard Specification forPolysulfone Resin for Medical Applications1This standard is issued under the fixed designation F702;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.1.Scope1.1 This specification covers polysulfone resin(poly(oxy-1,4-phenylenesulfonyl-1,4phenylene(dimethylmethylene)-1,4phenylene)as defined in ISO 251371,supplied by avendor in virgin form(pellets,powder,fabricated forms and soforth)for medical applications.This specification providesrequirements and associated test methods for this thermoplasticwhen it is intended for use in manufacturing medical devices orcomponents of medical devices.1.2 As with any material,some characteristics may bealtered by the processing techniques(such as molding,extrusion,machining,sterilization,and so forth)required forthe production of a specific part or device.Therefore,proper-ties of fabricated forms of this resin should be evaluated usingtest methods which are appropriate to ensure safety andefficacy as agreed upon by the vendor,purchaser,and regulat-ing bodies.1.3 The standard allows for designation of polysulfone resinfor all medical applications.The actual extent of performanceand suitability for a specific application must be evaluated bythe vendor,purchaser,and regulating bodies.1.4 The properties included in this specification are thoseapplicable for unfilled polysulfone(PSU)polymers with theaddition of colorants and processing aids.Indicated propertiesare for injection molded forms.Forms containing fillers orother additives,as well as polymer blends which contain PSU,or reclaimed materials,are not covered by this specification.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 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 PositionD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD6394 Specification for Sulfone Plastics(SP)F748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standards:3ISO 10993 Biological Evaluation of Medical DevicesISO 17025 General Requirements for the Competence ofTesting and Calibration LaboratoriesISO 251371 PlasticsSulfone Polymer Moulding and Ex-trusion MaterialsPart I:Designation System and Basisfor Specifications3.Significance and Use3.1 This specification is designed to recommend test meth-ods to establish a reasonable level of confidence concerning theperformance of unfilled polysulfone resins for use in medicaldevices.The properties listed should be considered in selectingmaterial according to specific end-use requirements.3.2 Polysulfones may be evaluated in implantable medicaldevices as well as in non-implant medical applications.Poly-sulfone resins intended for use in implant applications aremanufactured with more rigorous use of manufacturing and/ortesting controls,to assure consistency of properties,cleanlinessand biocompatibility.This is further elaborated in 4.1.1This 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 Sept.1,2010.Published October 2010.Originallyapproved in 1981.Last previous edition approved in 2003 as F702 98a(2003).DOI:10.1520/F0702-10.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Classification4.1 Polysulfone resin may be designated for either implantor non-implant medical applications.Designation of resins forimplant applications implies that the resins are manufactured incompliance with relevant aspects of GMP(Good Manufactur-ing Practices),use of process validation,enhanced controls,testing in a laborato