ASTM F1904-1998(2003) 测试体内粒子生物响应的标准操作规程
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【英文标准名称】:StandardPracticeforTestingtheBiologicalResponsestoParticlesInVivo
【原文标准名称】:测试体内粒子生物响应的标准操作规程
【标准号】:ASTMF1904-1998(2003)
【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(ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:生物配伍;生物响应;在体内;颗粒
【英文主题词】:biocompatibility;biologicalresponse;invivo;interleukins;particles;
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisdesignedtotesttheeffectofparticlesfromthematerialsonthehosttissues.Theappropriatenessofthemethodsshouldbecarefullyconsideredbytheusersincenotallmaterialsorapplicationsneedbetestedbythispractice.Thevalidityofthesestudiesinpredictingthehumanresponseisnotknownatthistimeandstudiessuchasdescribedhereareneeded.AbbreviationUsed:4.3.1LPS8212;Lipopolysaccharide(endotoxin).4.3.2LAL8212;Limulusamebocytelysate.4.3.3PCR8212;Polymerasechainreaction.4.3.4CD8212;Clusterdifferentiation.4.3.5HLA8212;Humanleukocyteantigens.1.1Thispracticecoverstheproductionofweardebrisanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremovetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponses.Someoftheprocedureslistedheremay,onfurthertesting,notprovetobepredictiveofclinicalresponsestoparticulatedebris.However,onlytheuseofstandardprotocolswillestablishwhichareusefultechniques.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,thisrecommendedpracticeindicateswhichnecessaryinformationshouldbesuppliedwiththetestresults.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithanasterisk.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】:
【原文标准名称】:测试体内粒子生物响应的标准操作规程
【标准号】:ASTMF1904-1998(2003)
【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(ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:生物配伍;生物响应;在体内;颗粒
【英文主题词】:biocompatibility;biologicalresponse;invivo;interleukins;particles;
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisdesignedtotesttheeffectofparticlesfromthematerialsonthehosttissues.Theappropriatenessofthemethodsshouldbecarefullyconsideredbytheusersincenotallmaterialsorapplicationsneedbetestedbythispractice.Thevalidityofthesestudiesinpredictingthehumanresponseisnotknownatthistimeandstudiessuchasdescribedhereareneeded.AbbreviationUsed:4.3.1LPS8212;Lipopolysaccharide(endotoxin).4.3.2LAL8212;Limulusamebocytelysate.4.3.3PCR8212;Polymerasechainreaction.4.3.4CD8212;Clusterdifferentiation.4.3.5HLA8212;Humanleukocyteantigens.1.1Thispracticecoverstheproductionofweardebrisanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremovetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponses.Someoftheprocedureslistedheremay,onfurthertesting,notprovetobepredictiveofclinicalresponsestoparticulatedebris.However,onlytheuseofstandardprotocolswillestablishwhichareusefultechniques.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,thisrecommendedpracticeindicateswhichnecessaryinformationshouldbesuppliedwiththetestresults.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithanasterisk.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】:
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