Product Code:SAE AS870
Title:Wrenching Configuration, Bi-Hexagonal (12 Point) Drive, Design Standard For
Issuing Committee:E-25 General Standards For Aerospace And Propulsion Systems
Scope:No scope available.【英文标准名称】:StandardPracticeforTestingtheBiologicalResponsestoParticlesinvivo
【原文标准名称】:测试活体中粒子生物反应的标准规范
【标准号】:ASTMF1904-1998(2008)
【标准状态】:现行
【国别】:美国
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;biologicalresponse;invivo;interleukins;particles;Biocompatibility;Degradation--surgicaldevices/applications;Growthfactors;Interleukins;Macrophages;Particleanalysis--medical/surgicalapplications
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisdesignedtotesttheeffectofparticlesfromthematerialsonthehosttissues.Theappropriatenessofthemethodsshouldbecarefullyconsideredbytheusersincenotallmaterialsorapplicationsneedbetestedbythispractice.Thevalidityofthesestudiesinpredictingthehumanresponseisnotknownatthistimeandstudiessuchasdescribedhereareneeded.AbbreviationUsed:LPS8212;Lipopolysaccharide(endotoxin).LAL8212;Limulusamebocytelysate.PCR8212;Polymerasechainreaction.CD8212;Clusterdifferentiation.HLA8212;Humanleukocyteantigens.1.1Thispracticecoverstheproductionofweardebrisanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremotetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponses.Someoftheprocedureslistedheremay,onfurthertesting,notprovetobepredictiveofclinicalresponsestoparticulatedebris.However,onlytheuseofstandardprotocolswillestablishwhichareusefultechniques.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,thisrecommendedpracticeindicateswhichnecessaryinformationshouldbesuppliedwithtestresults.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithan*.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:英语