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【英文标准名称】:StandardClassificationforTissueEngineeredMedicalProducts(TEMPs)
【原文标准名称】:组织工程医疗产品的标准分类
【标准号】:ASTMF2211-2004
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:F04.41
【标准类型】:(Classification)
【标准水平】:()
【中文主题词】:医疗产品;组织;分类
【英文主题词】:biomaterials;biomolecules;cells;classification;TEMPs;tissue-engineering
【摘要】:ThisclassificationoutlinesaspectsofTEMPswhichincludestheirindividualcomponents.Thecategoriesoutlinedinthisclassificationareintendedtolist,identify,andgrouptheareaspertinenttoTissueEngineeredMedicalProducts.ThisclassificationwillbeusedbytheTissueEngineeredMedicalProductssubcommitteesfortheorganizationofthedevelopmentofstandardsforthefieldoftissueengineering,TEMPs,andprotocolsfortheiruse.Thedevelopmentofproductsfromthenewtissueengineeringtechnologiesnecessitatescreationandimplementationofnewstandards(1).5SinceinteractionsmayoccuramongthecomponentsusedinTEMPs,newstandarddescriptions,testmethods,andpracticesareneededtoaidtheevaluationoftheseinteractions.ThedegreeofoverallriskforanygivenTEMPisreflectedbythenumberandtypesoftestsrequiredtodemonstrateproductsafetyandefficacy.1.1Thisclassificationoutlinestheaspectsoftissueengineeredmedicalproductsthatwillbedevelopedasstandards.Thisclassificationexcludestraditionaltransplantationoforgansandtissuesaswellastransplantationoflivingcellsaloneascellulartherapies.1.2ThisclassificationdoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministrationunder21CFRParts16and1270and21CFRParts207,807,and1271.1.3Thisstandarddoesnotpurporttoaddressspecificcomponentscoverdinotherstandards.Anysafetyareasassociatedwiththemedicalproduct''susewillnotbeaddressedinthisstandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_040_01
【页数】:8P.;A4
【正文语种】: