ASTM F981-2004(2010) 外科植入用生物材料与肌肉及骨骼材料效应相容性的评定

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【英文标准名称】:StandardPracticeforAssessmentofCompatibilityofBiomaterialsforSurgicalImplantswithRespecttoEffectofMaterialsonMuscleandBone
【原文标准名称】:外科植入用生物材料与肌肉及骨骼材料效应相容性的评定
【标准号】:ASTMF981-2004(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2004
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;boneimplantmaterials;cellularreaction;histology/histopathology;implantsmuscle;NewZealandrabbits;orthopaedicmedicaldevicesbone;plasticsurgicaldevices/applications;polyethylene(PE)surgica
【摘要】:Thispracticecoversatestprotocolforcomparingthelocaltissueresponseevokedbybiomaterials,fromwhichmedicalimplantabledevicesmightultimatelybefabricated,withthelocaltissueresponseelicitedbycontrolmaterialscurrentlyacceptedforthefabricationofsurgicaldevices.Thematerialsmayincludemetals(andmetalalloys),densealuminumoxide,andpolyethylenethatarestandardizedonthebasisofacceptablelong-termwell-characterizedlong-termresponse.Thecontrolsconsistentlyproducecellularreactionandwoundhealingtoadegreethathasbeenfoundtobeacceptabletothehost.1.1Thispracticeprovidesaseriesofexperimentalprotocolsforbiologicalassaysoftissuereactiontononabsorbablebiomaterialsforsurgicalimplants.Itassessestheeffectsofthematerialonanimaltissueinwhichitisimplanted.Theexperimentalprotocolisnotdesignedtoprovideacomprehensiveassessmentofthesystemictoxicity,immuneresponse,carcinogenicity,teratogenicity,ormutagenicityofthematerialsinceotherstandardsdealwiththeseissues.Itappliesonlytomaterialswithprojectedapplicationsinhumanswherethematerialswillresideinboneorsofttissueinexcessof30daysandwillremainunabsorbed.Itisrecommendedthatshort-termassays,accordingtoPracticeF763,firstbeperformed.Applicationsinotherorgansystemsortissuesmaybeinappropriateandarethereforeexcluded.ControlmaterialswillconsistofanyoneofthemetalalloysinSpecificationsF67,F75,F90,F136,F138,orF562,highpuritydensealuminumoxideasdescribedinSpecificationF603,ultrahighmolecularweightpolyethyleneasstatedinSpecificationF648orUSPpolyethylenenegativecontrol.1.2ThispracticeisacombinationofPracticeandPractice.Thepurpose,basicprocedure,andmethodofevaluationofeachtypeofmaterialaresimilar;therefore,theyhavebeencombined.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语