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【英文标准名称】:StandardGuideforPerformanceofLifetimeBioassayfortheTumorigenicPotentialofImplantMaterials
【原文标准名称】:植入物潜在致瘤性的使用期生物鉴定性能的标准指南
【标准号】:ASTMF1439-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【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】:F04.16
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:寿命(耐久性);试验;医学科学;外科植入物
【英文主题词】:biocompatibility;carcinogenicitytesting;tumorigenicitytesting
【摘要】:Thisguideisnotintendedtospecifytheexactmethodofconductingatestforanyparticularmaterialbutonlytopresentsomeofthecriteriathatshouldbeconsideredinmethoddesignandpossibleproblemsthatcouldleadtomisleadingresults.Inthedevelopmentoftheactualtestprotocol,itisrecommendedthatrecognizedtumorigenesisbioassayproceduresbeconsulted.Therecommendationsgiveninthisguidemaynotbeappropriateforallapplicationsortypesofimplantmaterials.Theserecommendationsshouldbeutilizedbyexperiencedtestingpersonnelinconjunctionwithotherpertinentinformationandtherequirementsofthespecificmaterialapplication.1.1Thisguideisintendedtoassistthebiomaterialstestinglaboratoryintheconductandevaluationoftumorigenicityteststoevaluatethepotentialfornewmaterialstoevokeaneoplasticresponse.Theprocedureisgenerallyreservedonlyforthosematerialswhichhavenotpreviouslybeenusedforhumanimplantationforasignificantperiodoftime.1.2AssessmentoftumorigenicityisoneofseveralproceduresemployedindeterminingthebiologicalresponsetoamaterialasrecommendedinPracticeF748.Itisassumedthattheinvestigatorhasalreadydeterminedthatthistypeoftestingisnecessaryforaparticularmaterialbeforeconsultingthisguide.TherecommendationsofPracticeF748shouldbeconsideredbeforeastudyiscommenced.1.3Wheneverpossible,itisrecommendedthatabatteryofgenotoxicityproceduresbeinitiatedandproposedasanalternativetoanin-vivotumorigenicitybioassay.Genotoxicityassaysmayalsobeconsideredasinitialscreeningproceduresduetothesensitivityoftheassays,thesignificantreductionintimetogainvaluabledata,andthedesiretoreducetheuseofanimalsfortesting.GenotoxicityassaysthatmaybeconsideredareoutlinedinGuidesE1262,E1263,E1280,andE2186,andPracticesE1397andE1398.Additionally,othergenotoxicitytestingwhichmightbeconsidered(butwhichdonotyethaveASTMtestmethods)includeSalmonella/Mammalian-MicrosomalPlateIncorporationMutagenicityAssay,InVivoCytogeneticsBoneMarrowChromosomalDamageAssay,BALB/3T3MorphologicalTransformationofMouseEmbryoCells,andtheMouseMicronucleusAssay.Theinvestigatorisadvisedtoconsidercarefullytheappropriatenessofaparticularmethodforhisapplicationafterareviewofthepublishedliterature.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:
【页数】:6P.;A4
【正文语种】: