【英文标准名称】:StandardGuideforAssessmentofAdventitiousAgentsinTissueEngineeredMedicalProducts(TEMPs)
【原文标准名称】:组织工程医疗产品中附加剂评定的标准指南
【标准号】:ASTMF2383-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:F04.45
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:医疗产品;试剂;实验室医学;组织;评定
【英文主题词】:adventitiousagents;microorganisms;TEMPs;testing
【摘要】:1.1Thisguideisintendedasaresourceforindividualsandorganizationsinvolvedintheproduction,delivery,andregulationoftissueengineeredmedicalproducts(TEMPs).ThesafetyfromcontaminationbypotentiallyinfectiousadventitiousagentsisimportantinthedevelopmentofallTEMPsaswellastheircomponents.Thisguideaddresseshowtoassesssafetyrisksassociatedwithadventitiousagentsandtheirbyproducts.Theseagentscurrentlyincludebacteria,fungi,mycoplasma,viruses,endotoxins,transmissiblespongiformencephalopathies(TSEs),andparasiticorganisms.ThisguidedoesnotaddressTEMPswithliveanimalcells,tissuesororgans,orhumancells,includingstemcells,grownonanyanimalfeedercells.Alsoexcludedispatientfollow-uptesting.1.2ThisguidedoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministrationunder21CFRParts16and1270and21CFRParts207,807and1271.ThisguidedoesapplytocellulartherapiesregulatedunderthePHS(PublicHealthService)act.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesandtodeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:11_100_99
【页数】:9P.;A4
【正文语种】: