【英文标准名称】:StandardPracticeforTestingforBiologicalResponsestoParticlesInVitro
【原文标准名称】:实验室测试粒子生物响应的标准操作规程
【标准号】:ASTMF1903-1998(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(US-ASTM)
【起草单位】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:颗粒;氧化氮;生长因数;巨噬细胞;生物配伍
【英文主题词】:biocompatibility;growthfactors;interleukins;macrophages;nitricoxide;particles;TNF
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisdesignedtotesttheeffectofparticlesfromthematerialsonmacrophages.Forsafetyreasons,theuseofnonhuman,nonprimatecellsisrecommendedinthispractice.Forlaboratoriesequippedandapprovedtoworkwithhumanbloodandtissue,theuseofthesesameprotocolswouldbeadvantageousfordevelopmentofunderstandingoftheinteractionofcellsandparticles.Theappropriatenessofthemethodsshouldbecarefullyconsideredbytheusersincenotallmaterialsorapplicationsneedbetestedbythispractice.Abbreviations:4.3.1LPS8212;lipopolysaccharide(endotoxin).4.3.2LAL8212;LimulusAmebocyteLysate.4.3.3ATCC8212;AmericanTypeCultureCollection.4.3.4FCS(FBS)8212;FetalCalfSerum.4.3.5NCS8212;NewbornCalfSerum.4.3.6PBS8212;PhosphateBufferedSaline.4.3.7HANKS8212;Abalancedsaltsolution.4.3.8MMPS8212;MatrixMetalloProteases.4.3.9RPMI16408212;SpecificGrowthMedium(RoswellParkMemorialInstitute).4.3.10HEPES8212;Abufferingsalt.1.1Thispracticecoverstheproductionofweardebrisanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadefobiologicalresponsesresultingindamagetoadjacentandremotetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponsesandtodetermineifthereiscorrelationwiththeinvivoresponses.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,welldescribedprotocolsareneededtocompareresultsfromdifferentinvestigatorsusingthesamematerialsandtocomparebiologicalresponsesforevaluating(ranking)differentmaterials.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithanasterisk.1.2Sincethepurposeofthesestudiesistopredicttheresponseinhumans,theuseofhumancellswouldprovidemuchinformation.Howeverintheinterestofsafetyinlaboratoryprotocols,theuseofnon-humanandnon-primatecellsisdescribed.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.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】: