ASTM F2210-2002 组织工程医疗产品中使用的细胞、组织和器官处理的标准指南
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【英文标准名称】:StandardGuideforProcessingCells,Tissues,andOrgansforUseinTissueEngineeredMedicalProducts
【原文标准名称】:组织工程医疗产品中使用的细胞、组织和器官处理的标准指南
【标准号】:ASTMF2210-2002
【标准状态】:现行
【国别】:
【发布日期】:2002
【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】:F04.43
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:cellandtissueengineering;cells;organs;processingofcells;tissueengineeredmedicalproducts;tissues;tissuesandorgans
【摘要】:Thisguidedescribesthegeneralproductdevelopmentcriteriaandanalysesapplicabletoprocessingofcells,tissues,andorgansusedfortheproductionofTEMPs.Forthepurposesofthisguide,cells,tissues,andorgansmaybederivedfromanyorganismatanydevelopmentalstageandinanystateofhealth.Forexample,thisguideappliestostem,progenitor,somatic,andgermlinecells,aswellascellsfromspecifictissueandorgantypes.Thisguidealsoappliestocells,tissues,andorgansfromhealthy,diseased,orinjuredembryostoadults.Cells,tissues,andorgansmaybecombinedwithascaffoldandmaycontainlocallyorsystemicallyactingbiomoleculesoradrug(medicinal)product.ThistypeofTEMPwouldbeax201C;combinationproduct.x201D;1.1Thisguidedescribestheprocessing,characterization,production,andqualityassuranceofcells,tissues,andorgansusedforTissueEngineeredMedicalProducts(TEMPs).Itconcernsaspectsofprocessingactivitiesforcells,tissues,andorganstobefurtherprocessed.Theseaspectsinclude:(1)cell,tissue,andorganprocessing(thatis,facility,reagents,andproceduresforreceipt,inspection,andstorage;tissueculturecomponents,biologicalriskfactors,andprocessingarea),(2)donors(humanandnonhuman)andscreening,and(3)cell,tissue,andorgancharacterizationandprocessing.1.2ThisguidedoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministration(FDA)under21CFRParts16and1270(1)and21CFRParts207,807,and1271(2).1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_01
【页数】:6P.;A4
【正文语种】:
【原文标准名称】:组织工程医疗产品中使用的细胞、组织和器官处理的标准指南
【标准号】:ASTMF2210-2002
【标准状态】:现行
【国别】:
【发布日期】:2002
【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】:F04.43
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:cellandtissueengineering;cells;organs;processingofcells;tissueengineeredmedicalproducts;tissues;tissuesandorgans
【摘要】:Thisguidedescribesthegeneralproductdevelopmentcriteriaandanalysesapplicabletoprocessingofcells,tissues,andorgansusedfortheproductionofTEMPs.Forthepurposesofthisguide,cells,tissues,andorgansmaybederivedfromanyorganismatanydevelopmentalstageandinanystateofhealth.Forexample,thisguideappliestostem,progenitor,somatic,andgermlinecells,aswellascellsfromspecifictissueandorgantypes.Thisguidealsoappliestocells,tissues,andorgansfromhealthy,diseased,orinjuredembryostoadults.Cells,tissues,andorgansmaybecombinedwithascaffoldandmaycontainlocallyorsystemicallyactingbiomoleculesoradrug(medicinal)product.ThistypeofTEMPwouldbeax201C;combinationproduct.x201D;1.1Thisguidedescribestheprocessing,characterization,production,andqualityassuranceofcells,tissues,andorgansusedforTissueEngineeredMedicalProducts(TEMPs).Itconcernsaspectsofprocessingactivitiesforcells,tissues,andorganstobefurtherprocessed.Theseaspectsinclude:(1)cell,tissue,andorganprocessing(thatis,facility,reagents,andproceduresforreceipt,inspection,andstorage;tissueculturecomponents,biologicalriskfactors,andprocessingarea),(2)donors(humanandnonhuman)andscreening,and(3)cell,tissue,andorgancharacterizationandprocessing.1.2ThisguidedoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministration(FDA)under21CFRParts16and1270(1)and21CFRParts207,807,and1271(2).1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_01
【页数】:6P.;A4
【正文语种】:
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