ASTM F2212-2009 作为组织工程医疗产品(TEMPs)用外科植入物和底层原材料的I型胶原特性的标准指南
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【英文标准名称】:StandardGuideforCharacterizationofTypeICollagenasStartingMaterialforSurgicalImplantsandSubstratesforTissueEngineeredMedicalProducts(TEMPs)
【原文标准名称】:作为组织工程医疗产品(TEMPs)用外科植入物和底层原材料的I型胶原特性的标准指南
【标准号】:ASTMF2212-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:F04.42
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:biomaterials;characterization;collagen;naturalmaterials;TEMPs;Collagen;Substrates--surgicalimplantapplications;Surgicalimplants;TEMPs(tissueengineeredmedicalproducts)
【摘要】:TheobjectiveofthisguideistoprovideguidanceinthecharacterizationofTypeIcollagenasastartingmaterialforsurgicalimplantsandsubstratesfortissueengineeredmedicalproducts(TEMPs).Thisguidecontainsalistingofphysicalandchemicalparametersthataredirectlyrelatedtothefunctionofcollagen.Thisguidecanbeusedasanaidintheselectionandcharacterizationoftheappropriatecollagenstartingmaterialforthespecificuse.Notalltestsorparametersareapplicabletoallusesofcollagen.Thecollagencoveredbythisguidemaybeusedinabroadrangeofapplications,forms,ormedicalproducts,forexample(butnotlimitedto)medicaldevices,tissueengineeredmedicalproducts(TEMPs)orcell,drug,orDNAdeliverydevicesforimplantation.Theuseofcollageninapracticalapplicationshouldbebased,amongotherfactors,onbiocompatibilityandphysicaltestdata.Recommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanytissueengineeredmedicalproductordrugdeliveryapplication.ThefollowinggeneralareasshouldbeconsideredwhendeterminingifthecollagensuppliedsatisfiesrequirementsforuseinTEMPs.Thesearesourceofcollagen,chemicalandphysicalcharacterizationandtesting,andimpuritiesprofile.Thefollowingdocumentsorotherappropriateguidancesfromappropriateregulatorybodiesrelatingtotheproduction,regulationandregulatoryapprovalofTEMPsproductsshouldbeconsideredwhendeterminingifthecollagensuppliedsatisfiesrequirementsforuseinTEMPs:FDACFR:
21CFR3:ProductJurisdiction:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=3
21CFR58:GoodLaboratoryPracticeforNonclinicalLaboratoryStudies:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
FDA/CDRHCFRandGuidances:
21CFRPart803:MedicalDeviceReporting:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803
21CFR812:InvestigationalDeviceExemptions:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812
21CFR814:PremarketApprovalofMedicalDevices:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814
21CFR820:QualitySystemRegulation:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
DesignControlGuidanceforMedicalDeviceManufacturers:
http://www.fda.gov/cdrh/comp/designgd.pdf
PreproductionQualityAssurancePlanningRecommendationsforMedicalDeviceManufacturers(FDA90-4236):
http://www.fda.gov/cdrh/manual/appende.html
TheReviewandInspectionofPremarketApprovalApplicationsundertheBioresearchMonitoringProgram
【原文标准名称】:作为组织工程医疗产品(TEMPs)用外科植入物和底层原材料的I型胶原特性的标准指南
【标准号】:ASTMF2212-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:F04.42
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:biomaterials;characterization;collagen;naturalmaterials;TEMPs;Collagen;Substrates--surgicalimplantapplications;Surgicalimplants;TEMPs(tissueengineeredmedicalproducts)
【摘要】:TheobjectiveofthisguideistoprovideguidanceinthecharacterizationofTypeIcollagenasastartingmaterialforsurgicalimplantsandsubstratesfortissueengineeredmedicalproducts(TEMPs).Thisguidecontainsalistingofphysicalandchemicalparametersthataredirectlyrelatedtothefunctionofcollagen.Thisguidecanbeusedasanaidintheselectionandcharacterizationoftheappropriatecollagenstartingmaterialforthespecificuse.Notalltestsorparametersareapplicabletoallusesofcollagen.Thecollagencoveredbythisguidemaybeusedinabroadrangeofapplications,forms,ormedicalproducts,forexample(butnotlimitedto)medicaldevices,tissueengineeredmedicalproducts(TEMPs)orcell,drug,orDNAdeliverydevicesforimplantation.Theuseofcollageninapracticalapplicationshouldbebased,amongotherfactors,onbiocompatibilityandphysicaltestdata.Recommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanytissueengineeredmedicalproductordrugdeliveryapplication.ThefollowinggeneralareasshouldbeconsideredwhendeterminingifthecollagensuppliedsatisfiesrequirementsforuseinTEMPs.Thesearesourceofcollagen,chemicalandphysicalcharacterizationandtesting,andimpuritiesprofile.Thefollowingdocumentsorotherappropriateguidancesfromappropriateregulatorybodiesrelatingtotheproduction,regulationandregulatoryapprovalofTEMPsproductsshouldbeconsideredwhendeterminingifthecollagensuppliedsatisfiesrequirementsforuseinTEMPs:FDACFR:
21CFR3:ProductJurisdiction:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=3
21CFR58:GoodLaboratoryPracticeforNonclinicalLaboratoryStudies:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
FDA/CDRHCFRandGuidances:
21CFRPart803:MedicalDeviceReporting:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803
21CFR812:InvestigationalDeviceExemptions:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812
21CFR814:PremarketApprovalofMedicalDevices:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814
21CFR820:QualitySystemRegulation:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
DesignControlGuidanceforMedicalDeviceManufacturers:
http://www.fda.gov/cdrh/comp/designgd.pdf
PreproductionQualityAssurancePlanningRecommendationsforMedicalDeviceManufacturers(FDA90-4236):
http://www.fda.gov/cdrh/manual/appende.html
TheReviewandInspectionofPremarketApprovalApplicationsundertheBioresearchMonitoringProgram
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