【英文标准名称】:StandardSpecificationforPolycarbonateResinforMedicalApplications
【原文标准名称】:医用聚碳酸酯树酯的标准规范
【标准号】:ASTMF997-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:plastics(thermoplastic);plasticsurgicaldevices/applications;polycarbonate(PC)plastics;polymers-surgicalapplications;resins-polycarbonate;seals;Plasticsurgicaldevices/applications--specifications;Polycarbonate(PC)--specifications;Polyme
【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】:G45
【国际标准分类号】:11_100_99
【页数】:3P.;A4
【正文语种】:英语