【英文标准名称】:StandardPracticeforTestingforBiologicalResponsestoParticlesInVitro
【原文标准名称】:对体外颗粒物的生物学响应试验的标准实施规程
【标准号】:ASTMF1903-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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;growthfactors;interleukins;macrophages;nitricoxide;particles;TNF&x03B1;;Biocompatibility;Degradation--surgicaldevices/applications;Growthfactors;Interleukins;Macrophages;Nitricoxide;Particle
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisdesignedtotesttheeffectofparticlesfromthematerialsonmacrophages.Theuseofnonhuman,nonprimatecellsisrecommendedinthispractice.Forlaboratoriesequippedandapprovedtoworkwithhumanbloodandtissue,theuseofthesesameprotocolswouldbeadvantageousfordevelopmentofunderstandingoftheinteractionofcellsandparticles.Theappropriatenessofthemethodsshouldbecarefullyconsideredbytheusersincenotallmaterialsorapplicationsneedbetestedbythispractice.Abbreviations:LPS8212;lipopolysaccharide(endotoxin).LAL8212;LimulusAmebocyteLysate.ATCC8212;AmericanTypeCultureCollection.FCS(FBS)8212;FetalCalfSerum.NCS8212;NewbornCalfSerum.PBS8212;PhosphateBufferedSaline.HANKS8212;Abalancedsaltsolution.MMPS8212;MatrixMetalloProteases.RPMI16408212;SpecificGrowthMedium(RoswellParkMemorialInstitute).HEPES8212;Abufferingsalt.1.1Thispracticecoverstheproductionofweardebrisanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremotetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponsesandtodetermineifthereiscorrelationwiththeinvivoresponses.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,welldescribedprotocolsareneededtocompareresultsfromdifferentinvestigatorsusingthesamematerialsandtocomparebiologicalresponsesforevaluating(ranking)differentmaterials.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithanasterisk*.1.2Sincethepurposeofthesestudiesistopredicttheresponseinhumans,theuseofhumancellswouldprovidemuchinformation.However,inthispractice,theuseofnon-humanandnon-primatecellsisdescribed.Iftheusershouldwishtoemploycelllinesfromhumans,celllinesareavailablefromATCCandmostoftheinformationandrecommendationswillstillapply.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语