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【英文标准名称】:StandardSpecificationforPolycarbonateResinforMedicalApplications
【原文标准名称】:医疗设备用聚碳酸酯树脂标准规范
【标准号】:ASTMF997-1998a(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】:(Specification)
【标准水平】:()
【中文主题词】:医学科学;聚碳酸酯;树脂;人造树脂;使用
【英文主题词】:plastics(thermoplastic);plasticsurgicaldevices/applications;polycarbonate(PC)plastics;polymers-surgicalapplications;resins-polycarbonate;seals
【摘要】:1.1Thisspecificationcoverspolycarbonateresinandprovidesrequirementsandassociatedtestmethodsforthisthermoplasticwhenitistobeusedinthemanufactureofmedicaldevicesorcomponentsofmedicaldevices.1.2Aswithanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthisresinshouldbeevaluatedusingthosetestmethodsthatareappropriatetoassuresafetyandefficacy.1.3Thepropertiesincludedinthisspecificationarethoseapplicableforpolycarbonateonly.Thebiocompatibilityofplasticcompoundsmadeupofpolycarbonateresincontainingcolorants,fillers,processingaids,orotheradditives,aswellaspolymerblendswhichcontainpolycarbonate,shouldnotbeassumed.Thebiocompatibilityofthesemodifiedpolycarbonatesmustbeestablishedbytestingthefinal(end-use)compositionsusingtheappropriatemethodsofevaluation.Inaddition,thebiocompatibilityofthematerialdependstoalargedegreeonthenatureoftheend-useapplication.Itis,therefore,necessarytospecifyasetofbiocompatibilitytestmethodsforeachnewanddistinctapplication.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G32
【国际标准分类号】:11_120_01;83_080_20
【页数】:3P.;A4
【正文语种】: