【英文标准名称】:StandardSpecificationforPolyetherketoneetherketoneketone(PEKEKK)ResinsforSurgicalImplantApplications
【原文标准名称】:外科植入用聚醚酮醚二酮树脂的标准规范
【标准号】:ASTMF1876-1998(2003)e1
【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】:聚醚酮醚二酮;聚醚酮醚二酮
【英文主题词】:PEKEKK;polyetherketoneetherketoneketone
【摘要】:1.1Thisspecificationcoverspolyetherketoneetherketoneketone(PEKEKK)resinsinvirginformsassuppliedbyavendor,suchasflakes,pellets,blocks,etc.Itprovidesrequirementsandassociatedtestmethodsforthesethermoplasticswhentheyaretobeusedinthemanufacturingofintracorporealdevices,suchassurgicalimplantsorcomponentsofsurgicalordentaldevices.1.2Aswithanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques,suchasmolding,extrusion,machining,assembly,sterilization,etc.requiredfortheproductionofaspecificpartordevice;therefore,propertiesoffabricatedformsoftheseresinsshouldbeevaluatedusingtestmethodsthatareappropriatetoassuresafetyandefficacyasagreeduponbythevendor,purchaser,andregulatingbodies.1.3ThepropertiesincludedinthisspecificationarethoseapplicableforPEKEKKresinsonly.Fabricatedforms,materialorformscontainingcolorants,fillers,processingaids,orotheradditives,aswellaspolymerblendsthtcontainPEKEKK,arenotcoveredbythisspecification.1.4Thisspecificationisdesignedtorecommendphysical,chemical,andbiologicaltestmethodstoestablishareasonablelevelofconfidenceconcerningtheperformanceofvirginPEKEKKresinsforuseinmedicaldevices.Thepropertieslistedshouldbeconsideredinselectingmaterialaccordingtothespecificend-userequirement.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】: