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【英文标准名称】:StandardClassificationforVinylChloridePlasticsUsedinBiomedicalApplication
【原文标准名称】:生物医学用氯乙烯塑料的标准分类
【标准号】:ASTMF665-1998(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】:(Classification)
【标准水平】:()
【中文主题词】:分类系统;医学科学;氯乙烯;塑料;使用;医疗设备
【英文主题词】:plasticsurgicaldevices/application;vinylchlorideplastics
【摘要】:Thisclassificationwasdevelopedtopermittheadditionofdescriptivesymbolsandvaluesforfurthernewformulationswithimprovedpropertieswithoutcompletereorganizationofthestandardandtofacilitatetheincorporationoffuturenewtestmethodstokeeppacewithchangingindustryrequirements.1.1Thisclassificationprovidesguidancetoengineersandusersintheselectionofpracticalvinylchlorideplasticsformedicalapplicationsandfurtherprovidesamethodforspecifyingthesematerialsbyuseofasimplelinecall-outdesignation.Thisclassificationexcludesvinylchlorideplasticsusedinlong-termimplants.1.2Useismadeofaclassificationschemebasedonthepremisethatthecompositionofvinylchlorideplastics,copolymers,fillers,plasticizers,stabilizers,andotheradditivesinthesesystemscanbearrangedintocharacteristicmaterialdesignations.1.3Inallcaseswheretheprovisionsofthisclassificationsystemwouldconflictwiththoseofthedetailedspecificationforaparticulardevice,thelattershalltakeprecedence.Note18212;Forcasesinwhichthevinylchlorideplasticmaybeusedforpurposeswheretherequirementsaretoospecifictobecompletelydescribedbythisclassificationsystem,itisadvisableforthepurchasertoconsultthesuppliertosecureadjustmentofthepropertiestosuittheactualconditionstowhichthedeviceistobesubjected.1.4Thebiocompatibilityofvinylchlorideplasticsasaclassofmaterialshasnotbeenestablished.Sincemanycompositionsandformulationsfallunderthisclass,itisessentialthatthefabricators/devicemanufacturersassurethesafetyandefficacyofthespecificcompositionorformulation,initsintendedapplication,usingstate-of-the-arttestmethods.1.5Thisclassificationistoassisttheinterfacebetweenthematerialsupplierandthedevicemanufacturer(fabricator)whopurchasesaformulatedvinylchlorideplasticforacomponent.Forthosedevicemanufacturers(fabricators)whodotheirownformulating,compounding,extrusion,molding,andsoforth,thisclassificationdoesnotapply.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:07_100_10;11_040_40
【页数】:4P.;A4
【正文语种】: