【英文标准名称】:StandardCriteriaforImplantableThermosetEpoxyPlastics
【原文标准名称】:可植入的热固性环氧塑料标准
【标准号】:ASTMF602-1998a(2003)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:(Guide)
【标准水平】:()
【中文主题词】:准则;医疗设备;医学科学;塑料;环氧衍生物
【英文主题词】:epoxy(EP)plastics-surgicalimplants;plastics(thermosetting);plasticsurgicaldevices/applications;polymers-surgicalapplications;resins-epoxy
【摘要】:1.1ThesecriteriacoverthermosetplasticsbasedondiglycidylethersofbisphenolA(DGEBPA)andappropriatecuringagentsorcatalystsasopposedtothermoplasticsbasedonepoxystructures.1.2Thesecriteriaaregenericandareintendedtoprovidedefinitionsandastandarddescriptionofepoxyplasticsusedinimplantabledevices.Itisalsointendedtoserveasastandardguideforthepreparationofmorespecificdocumentswithvaluesandlimitscoveringspecificenduses.1.3Compliancewiththesecriteriashallnotbeconstruedasanendorsementofimplantability.Thebiocompatibilityofepoxyplasticsasaclasshasnotbeenestablished.Epoxyplasticisagenerictermrelatingtotheclassofpolymersformedfromepoxyresins,certaincuringagentsorcatalysts,andvariousadditives.Sincemanycompositionsandformulationsfallunderthisclass,itisessentialthattheformulatororfabricatorensurebiocompatibilityofthespecificcompositionorformulationinitsintendedenduse.Sincethesecriteriaprovideguidanceforthepreparationofmorespecificdocumentscoveringspecificenduses,thesedocumentswillprovidebasesforstandardizedevaluationofbiocompatibilityappropriateforaspecificenduse.1.4Eachofthepropertieslistedshallbeconsideredinselectingmaterialsforspecificenduses.Alistofselectedpropertieswithlimitingvaluesassignedissuggestedforseparateproductspecifications.1.5Allofthepropertiesandtestmethodslistedmaynotbepertinentinanyspecificsituation,normayallofthetestsoutlinedberequired.1.6Thesecriteriaarelimitedtofunctionallyorfullycuredepoxyplastics.Uncuredorincompletelycuredformulationsarespecificallyexcluded.1.7Theepoxyplasticscoveredbythisstandardarethosetobeevaluatedforuseinimplantablebiomedicaldevices.Thetermimplantableishereinconsideredtoincludedevicesusedinvivofortimeperiodsinexcessof30days.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】: