ASTM F1855-2000(2005) 医用聚甲醛(乙缩醛)标准规范
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【英文标准名称】:StandardSpecificationforPolyoxymethylene(Acetal)forMedicalApplications
【原文标准名称】:医用聚甲醛(乙缩醛)标准规范
【标准号】:ASTMF1855-2000(2005)
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:acetal;copolymer;homopolymer;polyoxymethylene;thermoplasticresin
【摘要】:1.1Thisspecificationcoverspolyoxymethylene(acetal)resinformedicalapplications.Thisspecificationprovidesrequirementsandassociatedtestmethodsforaformofthisthermoplasticwhichisintendedforuseinmanufacturingmedicaldevices,instrumentationorcomponentsthereof.1.2Aswillanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques(suchasmolding,extrusion,machining,sterilization,etc.)requiredforaspecificapplication.Thereforepropertiesoffabricatedformsofthisresinshouldbeevaluatedusingappropriatetestmethodstoassuresafetyandefficacy.1.3AlthoughthisresinhasbeenusedandforspecificimplantapplicationsintheUnitedStates,theuseofthisresininmedicaldevicesshouldberestrictedtonon-implantapplicationsuntilbiocompatibilityevaluationsappropriatefortheintendedapplicationsaresuccessfullycompleted.1.4Thebiocompatibilityofplasticcompoundsmadeupofpolyoxymethylene(acetal)resincontainingcolorants,fillers,processingaids,orotheradditivesaswellaspolymerblendswhichcontainpolyacetalshouldnotbeassumedonthebasisofresinbiocompatibilityalone.Theirbiocompatibilitymustbeestablishedbytestingthefinal(end-use)compositionsusingevaluationmethodsappropriatefortheintendedapplications.Itshouldbenotedthatthetypes,testlevelsandbiologicaleffectsofextractivesyieldedbytheadditivescontainedinacompoundorblendmayalsohavetobeevaluatedforsomeend-useapplications.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:11_040_30;83_080_20
【页数】:2P.;A4
【正文语种】:
【原文标准名称】:医用聚甲醛(乙缩醛)标准规范
【标准号】:ASTMF1855-2000(2005)
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:acetal;copolymer;homopolymer;polyoxymethylene;thermoplasticresin
【摘要】:1.1Thisspecificationcoverspolyoxymethylene(acetal)resinformedicalapplications.Thisspecificationprovidesrequirementsandassociatedtestmethodsforaformofthisthermoplasticwhichisintendedforuseinmanufacturingmedicaldevices,instrumentationorcomponentsthereof.1.2Aswillanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques(suchasmolding,extrusion,machining,sterilization,etc.)requiredforaspecificapplication.Thereforepropertiesoffabricatedformsofthisresinshouldbeevaluatedusingappropriatetestmethodstoassuresafetyandefficacy.1.3AlthoughthisresinhasbeenusedandforspecificimplantapplicationsintheUnitedStates,theuseofthisresininmedicaldevicesshouldberestrictedtonon-implantapplicationsuntilbiocompatibilityevaluationsappropriatefortheintendedapplicationsaresuccessfullycompleted.1.4Thebiocompatibilityofplasticcompoundsmadeupofpolyoxymethylene(acetal)resincontainingcolorants,fillers,processingaids,orotheradditivesaswellaspolymerblendswhichcontainpolyacetalshouldnotbeassumedonthebasisofresinbiocompatibilityalone.Theirbiocompatibilitymustbeestablishedbytestingthefinal(end-use)compositionsusingevaluationmethodsappropriatefortheintendedapplications.Itshouldbenotedthatthetypes,testlevelsandbiologicaleffectsofextractivesyieldedbytheadditivescontainedinacompoundorblendmayalsohavetobeevaluatedforsomeend-useapplications.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:11_040_30;83_080_20
【页数】:2P.;A4
【正文语种】:
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