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【英文标准名称】:StandardSpecificationforImplantableEpoxyElectronicEncapsulants
【原文标准名称】:可植入的环氧树脂电子胶囊密封材料标准规范
【标准号】:ASTMF641-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:encapsulants;evaluationofbiocompatibility;implantablemedicaldevices;Electronicmaterials/applications--specifications;Epoxy(EP)plastics--specifications;Implantablesurgicalmaterials/applications--specifications;Pacemakers;Pulsegenerators;
【摘要】:1.1ThisspecificationcoversthermosetplasticsbasedondiglycidylethersofbisphenolAandaminofunctionalcuringagentsoraminecatalysts.1.2Theepoxyencapsulantscoveredbythisspecificationareintendedtoprovideatissue-compatibleprotectivecoveringforimplantablemedicaldevicessuchaspulsegenerators,telemetrydevicesandRFreceivers.Thebiocompatibilityofepoxyplasticshasnotbeenestablished.Epoxyplasticisagenerictermrelatingtotheclassofpolymersformedfromepoxyresins,certaincuringagentsorcatalystsandvariousadditives.Sincemanycompositionsandformulationsfallunderthiscategory,itisessentialthatthefabricatorassuresafetyofimplantabilityofthespecificcompositionorformulationfortheintendedusebycurrentstate-of-the-arttestmethods.Thisspecificationcanbeusedasabasisforstandardizedevaluationofbiocompatibilityforsuchimplantableencapsulants.1.3Theencapsulantscoveredbythisspecificationareforuseindevicesintendedaslong-termimplants.1.4Limitations8212;Thisspecificationcoversonlytheinitialqualificationofepoxyencapsulantsforimplantableelectroniccircuitry.Someoftherequirementsarenotapplicabletoroutinelot-to-lotqualitycontrol.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语