ASTM_F_997_-_10.pdf

Designation:F99710Standard Specification forPolycarbonate Resin for Medical Applications1This standard is issued under the fixed designation F997;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 polycarbonate resin and pro-vides requirements and associated test methods for this ther-moplastic when it is to be used in the manufacture of medicaldevices or components of medical devices.1.2 As with any material,some characteristics may bealtered by the processing techniques(such as molding,extrusion,machining,assembly,sterilization,and so forth)required for the production of a specific part or device.Therefore,properties of fabricated forms of this resin should beevaluated using those test methods that are appropriate toassure safety and efficacy.1.3 The properties included in this specification are thoseapplicable for polycarbonate only.The biocompatibility ofplastic compounds made up of polycarbonate resin containingcolorants,fillers,processing aids,or other additives,as well aspolymer blends which contain polycarbonate,should not beassumed.The biocompatibility of these modified polycarbon-ates must be established by testing the final(end-use)compo-sitions using the appropriate methods of evaluation.Inaddition,the biocompatibility of the material depends to a largedegree on the nature of the end-use application.It is,therefore,necessary to specify a set of biocompatibility test methods foreach new and distinct application.1.4 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:2D256 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 PositionD790 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 DisplacementD883 Terminology Relating to PlasticsD955 Test Method of Measuring Shrinkage from MoldDimensions of ThermoplasticsD1003 Test Method for Haze and Luminous Transmittanceof Transparent PlasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1600 Terminology forAbbreviated Terms Relating to Plas-ticsD1898 Practice for Sampling of Plastics(Withdrawn 1998)3D3892 Practice for Packaging/Packing of PlasticsD3935 Specification for Polycarbonate(PC)Unfilled andReinforced MaterialF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 Underwriters Laboratories Document:UL Standard 94 Tests and Flammability of Plastic Materialsfor Parts in Devices and Appliances42.3 Code of Federal Regulations:Title 21 CFR Subpart 177.158052.4 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices63.Significance and Use3.1 This specification is designed to recommend physical,chemical,and biological test methods to establish a reasonable1This 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 Jan.1,2010.Published January 2010.Originallyapproved in 1986.Last previous edition approved in 2003 as F997 98a(2003).DOI:10.1520/F0997-10.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from Underwriters Laboratories(UL),333 Pfingsten Rd.,Northbrook,IL 60062-2096,http:/.5Available from Standardization Documents Order Desk,Bldg.4 Section D,700Robbins Ave.,Philadelphia,PA 191115094,Attn:NPODS.6Available 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 level of confidence concerning the performance of unfilledpolycarbonate resins for use in medical devices.The propertieslisted should be considered in selecting material according tothe specific end-use requirements.4.Classification4.1 Types of polycarbonate plastics,molding,and extrusiongrades are described in Specification D3935.5.General Re