【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【英文标准名称】:Plastics-Injectionmouldingoftestspecimensofthermoplasticmaterials-Part3:Smallplates(ISO294-3:2002);GermanversionENISO294-3:2003
【原文标准名称】:塑料.热塑性材料试样的注模塑法.第3部分:小板
【标准号】:DINENISO294-3-2003
【标准状态】:现行
【国别】:德国
【发布日期】:2003-12
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:薄板材;塑料;试样;喷射铸造法;试验板;试件;热塑性聚合物;模塑材料;工具;试样制备;尺寸;板;注塑模;注射成型机;双;试验
【英文主题词】:Dimensions;Double;Injectionmoulding;Injectionmouldingmachines;Injectionmoulds;Mouldingmaterials;Plastics;Plates;Sheets;Specimenpreparation;Testpieces;Testplate;Testspecimens;Testing;Thermopla
【摘要】:Thispartofthestandardspecifiestwotwo-cavitymoulds,thetypeD1andD2ISOmoulds,fortheinjectionmouldingofsmallplatesmeasuring60mm*60mmwithapreferredthicknessof1mm(typeD1)or2mm(typeD2),whichcanbeusedforavarietyoftests.Themouldsmayadditionallybefittedwithinsertsforstudyingtheeffectsofweldlinesonthemechanicalproperties(annexA).#,,#
【中国标准分类号】:G31
【国际标准分类号】:83_080_20
【页数】:13P;A4
【正文语种】:德语