ASTM F2386-2004 组织工程医疗产品的保存的标准指南
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【英文标准名称】:StandardGuideforPreservationofTissueEngineeredMedicalProducts(TEMPs)
【原文标准名称】:组织工程医疗产品的保存的标准指南
【标准号】:ASTMF2386-2004
【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】:F04.43
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:医疗产品;组织;保存
【英文主题词】:biomaterials;cellandtissueengineering;cells;tissueengineeredmedicalproducts(TEMPs);tissues
【摘要】:ThepreservationofTEMPscanaffecttheirsubsequentcharacteristics(forexample,structural,mechanical,biological,andmetabolicproperties).Theaspectsofpreservationthatcanmostadverselyaffectthesecharacteristicsinclude,butarenotlimitedto,cooling,coolingrates,warming,warmingrates,freezing,freezingrates,thawing,thawingrates,preservationmedium,andpre-andpost-processing.TheintentofthisguideistooutlineproceduresthatcanminimizethelossordegradationofthedesiredcharacteristicsoftheTEMPs.1.1Thisguidecoversthedevelopmentofstandardsrelatedtothepreservationofcells,tissues,andtissueengineeredmedicalproducts(TEMPs).Preservationtechniquesincludefreezing,vitrification,andhypothermicpreservation.Thisguidediscussespreservation,includingissuesofpre-preservationprocessing,theprocessofpreservation,storage,transport,recovery,post-preservationprocessing,qualityassurance,andprocesscontrol.1.2Thisguidecontainsgeneralguidelinesforthepreservationofcells,tissues,andtissueengineeredmedicalproducts(TEMPs)andwillidentifymorespecificparametersrelevanttothepreservationofTEMPs.1.3ThisguidedoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministration(FDA)under21CFRParts16and1270and21CFRParts207,807,and1271.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_100
【页数】:5P.;A4
【正文语种】:
【原文标准名称】:组织工程医疗产品的保存的标准指南
【标准号】:ASTMF2386-2004
【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】:F04.43
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:医疗产品;组织;保存
【英文主题词】:biomaterials;cellandtissueengineering;cells;tissueengineeredmedicalproducts(TEMPs);tissues
【摘要】:ThepreservationofTEMPscanaffecttheirsubsequentcharacteristics(forexample,structural,mechanical,biological,andmetabolicproperties).Theaspectsofpreservationthatcanmostadverselyaffectthesecharacteristicsinclude,butarenotlimitedto,cooling,coolingrates,warming,warmingrates,freezing,freezingrates,thawing,thawingrates,preservationmedium,andpre-andpost-processing.TheintentofthisguideistooutlineproceduresthatcanminimizethelossordegradationofthedesiredcharacteristicsoftheTEMPs.1.1Thisguidecoversthedevelopmentofstandardsrelatedtothepreservationofcells,tissues,andtissueengineeredmedicalproducts(TEMPs).Preservationtechniquesincludefreezing,vitrification,andhypothermicpreservation.Thisguidediscussespreservation,includingissuesofpre-preservationprocessing,theprocessofpreservation,storage,transport,recovery,post-preservationprocessing,qualityassurance,andprocesscontrol.1.2Thisguidecontainsgeneralguidelinesforthepreservationofcells,tissues,andtissueengineeredmedicalproducts(TEMPs)andwillidentifymorespecificparametersrelevanttothepreservationofTEMPs.1.3ThisguidedoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministration(FDA)under21CFRParts16and1270and21CFRParts207,807,and1271.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_100
【页数】:5P.;A4
【正文语种】:
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