ASTM_F_997_-_18.pdf

Designation:F99718Standard 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.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-ticsD3892 Practice for Packaging/Packing of PlasticsD3935 Classification System and Basis for Specification forPolycarbonate(PC)Unfilled and Reinforced MaterialF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 Underwriters Laboratories Document:UL Standard 94 Tests for Flammability of Plastic Materialsfor Parts in Devices and Appliances31This 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 Dec.1,2018.Published February 2019.Originallyapproved in 1986.Last previous edition approved in 2010 as F997 10.DOI:10.1520/F0997-18.2For 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 Underwriters Laboratories(UL),333 Pfingsten Rd.,Northbrook,IL 60062-2096,http:/.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 2.3 Code of Federal Regulations:Title 21 CFR Subpart 177.1580 Polycarbonate Resins42.4 ISO Standard:ISO 10993-1 Biological Evaluation of Medical DevicesPart 1:Evaluation and testing within a risk managementprocess53.Significance and Use3.1 This specification is designed to recommend test meth-ods to establish a reasonabl