ASTM F2026-2007a 外科植入物用聚醚醚酮(PEEK)聚合物的标准规范
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【英文标准名称】:StandardSpecificationforPolyetheretherketone(PEEK)PolymersforSurgicalImplantApplications
【原文标准名称】:外科植入物用聚醚醚酮(PEEK)聚合物的标准规范
【标准号】:ASTMF2026-2007a
【标准状态】:现行
【国别】:
【发布日期】:2007
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:牙齿植入物;聚合物;外科植入物;热塑性聚合物
【英文主题词】:PEEK;polyetheretherketone;
【摘要】:1.1Thisspecificationcoverspolyetheretherketone(PEEK)polymerinvirginformsassuppliedbyavendor(pellets,powder,andsoforth).Itprovidesrequirementsandassociatedtestmethodsforthesethermoplasticswhentheyaretobeusedinthemanufactureofintracorporealdevicessuchassurgicalimplantsorcomponentsofsurgicalordentaldevices.1.2Aswithanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques(molding,extrusion,machining,assembly,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthesepolymersshouldbeevaluatedusingtestmethodswhichareappropriatetoensuresafetyandefficacyasagreeduponbythevendor,purchaser,andregulatingbodies.1.3ThepropertiesincludedinthisspecificationarethoseapplicableforPEEKpolymersonly.Indicatedpropertiesareforinjectionmoldedforms.Fabricatedforms,materialorformscontainingcolorants,fillers,processingaids,orotheradditives,aswellaspolymerblendswhichcontainPEEK,orreclaimedmaterials,arenotcoveredbythisspecification.1.4Thisspecificationisdesignedtorecommendphysical,chemical,andbiologicaltestmethodstoestablishareasonablelevelofconfidenceconcerningtheperformanceofvirginPEEKpolymersforuseinmedicalimplantdevices.Thepropertieslistedshouldbeconsideredinselectingmaterial(s)inaccordancewiththespecificend-userequirements.1.5Whenevaluatingmaterialinaccordancewiththisspecification,hazardousmaterials,operations,andequipmentmaybeinvolved.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_30;11_040_30
【页数】:4P.;A4
【正文语种】:
【原文标准名称】:外科植入物用聚醚醚酮(PEEK)聚合物的标准规范
【标准号】:ASTMF2026-2007a
【标准状态】:现行
【国别】:
【发布日期】:2007
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:牙齿植入物;聚合物;外科植入物;热塑性聚合物
【英文主题词】:PEEK;polyetheretherketone;
【摘要】:1.1Thisspecificationcoverspolyetheretherketone(PEEK)polymerinvirginformsassuppliedbyavendor(pellets,powder,andsoforth).Itprovidesrequirementsandassociatedtestmethodsforthesethermoplasticswhentheyaretobeusedinthemanufactureofintracorporealdevicessuchassurgicalimplantsorcomponentsofsurgicalordentaldevices.1.2Aswithanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques(molding,extrusion,machining,assembly,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthesepolymersshouldbeevaluatedusingtestmethodswhichareappropriatetoensuresafetyandefficacyasagreeduponbythevendor,purchaser,andregulatingbodies.1.3ThepropertiesincludedinthisspecificationarethoseapplicableforPEEKpolymersonly.Indicatedpropertiesareforinjectionmoldedforms.Fabricatedforms,materialorformscontainingcolorants,fillers,processingaids,orotheradditives,aswellaspolymerblendswhichcontainPEEK,orreclaimedmaterials,arenotcoveredbythisspecification.1.4Thisspecificationisdesignedtorecommendphysical,chemical,andbiologicaltestmethodstoestablishareasonablelevelofconfidenceconcerningtheperformanceofvirginPEEKpolymersforuseinmedicalimplantdevices.Thepropertieslistedshouldbeconsideredinselectingmaterial(s)inaccordancewiththespecificend-userequirements.1.5Whenevaluatingmaterialinaccordancewiththisspecification,hazardousmaterials,operations,andequipmentmaybeinvolved.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_30;11_040_30
【页数】:4P.;A4
【正文语种】:
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