ASTM_F_641_-_09_2014.pdf

Designation:F64109(Reapproved 2014)Standard Specification forImplantable Epoxy Electronic Encapsulants1This standard is issued under the fixed designation F641;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 thermoset plastics based ondiglycidyl ethers of bisphenol A and amino functional curingagents or amine catalysts.1.2 The epoxy encapsulants covered by this specificationare intended to provide a tissue-compatible protective coveringfor implantable medical devices such as pulse generators,telemetry devices and RF receivers.The biocompatibility ofepoxy plastics has not been established.Epoxy plastic is ageneric term relating to the class of polymers formed fromepoxy resins,certain curing agents or catalysts and variousadditives.Since many compositions and formulations fallunder this category,it is essential that the fabricator assuresafety of implantability of the specific composition or formu-lation for the intended use by current state-of-the-art testmethods.This specification can be used as a basis for stan-dardized evaluation of biocompatibility for such implantableencapsulants.1.3 The encapsulants covered by this specification are foruse in devices intended as long-term implants.1.4 LimitationsThis specification covers only the initialqualification of epoxy encapsulants for implantable electroniccircuitry.Some of the requirements are not applicable toroutine lot-to-lot quality control.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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 PlasticsD638 Test Method for Tensile Properties of PlasticsD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and MoistureD1239 Test Method for Resistance of Plastic Films toExtraction by ChemicalsD1434 Test Method for Determining Gas Permeability Char-acteristics of Plastic Film and SheetingD2240 Test Method for Rubber PropertyDurometer Hard-nessD2471 Practice for Gel Time and Peak Exothermic Tempera-ture of Reacting Thermosetting Resins(Withdrawn 2008)3D2562 Practice for Classifying Visual Defects in PartsMolded from Reinforced Thermosetting PlasticsD2566 Test Method for Linear Shrinkage of Cured Thermo-setting Casting Resins During Cure(Withdrawn 1993)3D2734 Test Methods for Void Content of Reinforced PlasticsD3137 Test Method for Rubber PropertyHydrolytic Sta-bility(Withdrawn 0)3F74 Practice for Determining Hydrolytic Stability of PlasticEncapsulants for Electronic Devices(Withdrawn 1994)31This 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 Nov.1,2014.Published November 2014.Originallyapproved in 1979.Last previous edition approved in 2009 as F641 09.DOI:10.1520/F0641-09R14.2For 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 F135 Test Method for Embedment Stress Caused by CastingCompounds on Glass-Encased Electronic(Withdrawn1997)3F602 Criteria for Implantable Thermoset Epoxy PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 AAMI Standard:EOS-D E-O Sterilization Standard42.3 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices53.Classification3.1 Encapsulants shall be classified as follows:3.1.1 T