ASTM_F_602_-_09_2015.pdf

Designation:F60209(Reapproved 2015)Standard Criteria forImplantable Thermoset Epoxy Plastics1This standard is issued under the fixed designation F602;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 These criteria cover thermoset plastics based on digly-cidyl ethers of bisphenol A(DGEBPA)and appropriate curingagents or catalysts as opposed to thermoplastics based onepoxy structures.1.2 These criteria are generic and are intended to providedefinitions and a standard description of epoxy plastics used inimplantable devices.It is also intended to serve as a standardguide for the preparation of more specific documents withvalues and limits covering specific end uses.1.3 Compliance with these criteria shall not be construed asan endorsement of implantability.The biocompatibility ofepoxy plastics as a class has not been established.Epoxyplastic is a generic term relating to the class of polymersformed from epoxy resins,certain curing agents or catalysts,and various additives.Since many compositions and formula-tions fall under this class,it is essential that the formulator orfabricator ensure biocompatibility of the specific compositionor formulation in its intended end use.Since these criteriaprovide guidance for the preparation of more specific docu-ments covering specific end uses,these documents will providebases for standardized evaluation of biocompatibility appropri-ate for a specific end use.1.4 Each of the properties listed shall be considered inselecting materials for specific end uses.A list of selectedproperties with limiting values assigned is suggested forseparate product specifications.1.5 All of the properties and test methods listed may not bepertinent in any specific situation,nor may all of the testsoutlined be required.1.6 These criteria are limited to functionally or fully curedepoxy plastics.Uncured or incompletely cured formulationsare specifically excluded.1.7 The epoxy plastics covered by this standard are those tobe evaluated for use in implantable biomedical devices.Theterm implantable is herein considered to include devices usedin vivo for time periods in excess of 30 days.1.8 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:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD150 Test Methods for AC Loss Characteristics and Permit-tivity(Dielectric Constant)of Solid Electrical InsulationD257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD570 Test Method for Water Absorption of PlasticsD621 Test Methods for Deformation of Plastics Under Load(Withdrawn 1994)3D638 Test Method for Tensile Properties of PlasticsD785 Test Method for Rockwell Hardness of Plastics andElectrical Insulating MaterialsD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD952 Test Method for Bond or Cohesive Strength of SheetPlastics and Electrical Insulating MaterialsD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and MoistureD1434 Test Method for Determining Gas Permeability Char-acteristics of Plastic Film and SheetingD1763 Specification for Epoxy ResinsD2393 Test Method for Viscosity of Epoxy Resins andRelated Components(Withdrawn 1992)3D2471 Practice for Gel Time and Peak Exothermic Tempera-ture of Reacting Thermosetting Resins(Withdrawn 2008)3D2562 Practice for Classifying Visual Defects in Parts1These criteria are under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devicesand are the direct responsibility of Subcommit-tee F04.11 on Polymeric Materials.Current edition approved March 1,2015.Published May 2015.Originallyapproved in 1978.Last previous edition approved in 2014 as F602 09(2014).DOI:10.1520/F0602-09R15.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Molded from Reinforced Thermosetting PlasticsD2734 Test Methods for Void Content of Reinforced PlasticsD3137 Test Method for Rubber PropertyHydrolytic Sta-bilityE96/E96M Test Methods for Water Vapor Transmission ofMaterialsF74 Practice for Dete