NF M15-025-2004 加热燃料.脂肪酸甲脂(FAME).要求和试验方法
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【英文标准名称】:Heatingfuels-Fattyacidmethylesters(FAME)-Requirementsandtestmethods.
【原文标准名称】:加热燃料.脂肪酸甲脂(FAME).要求和试验方法
【标准号】:NFM15-025-2004
【标准状态】:现行
【国别】:法国
【发布日期】:2004-04-01
【实施或试行日期】:2004-04-05
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:G17
【国际标准分类号】:75_160_20
【页数】:14P;A4
【正文语种】:其他
【原文标准名称】:加热燃料.脂肪酸甲脂(FAME).要求和试验方法
【标准号】:NFM15-025-2004
【标准状态】:现行
【国别】:法国
【发布日期】:2004-04-01
【实施或试行日期】:2004-04-05
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:G17
【国际标准分类号】:75_160_20
【页数】:14P;A4
【正文语种】:其他
下载地址: 点击此处下载
上一篇: NF T53-033-1-2004 塑料.丙烯腈-丁二烯-苯乙烯共聚物(ABS)模塑和挤塑材料.第1部分:命名体系和基本规范
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下一篇: NF T47-109-2004 输送带.导电率.规范和试验方法
【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】:StandardSpecificationforInternationalShoreConnectionsforMarineFireApplications
【原文标准名称】:船舶灭火用国际海岸通讯线
【标准号】:ASTMF1121-1987(2004)
【标准状态】:现行
【国别】:
【发布日期】:1987
【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】:F25.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:导航;火灾;无线电电路;国际的;海岸
【英文主题词】:firefightingsystems;internationalshoreconnections;hose-to-hoseconnection;marinefireapplications;portableuniversalcouplings;shipboardfiremainsystems;strickenship
【摘要】:1.1Thisspecificationcoversthedesignandmanufactureofinternationalshoreconnectionstobeusedwithmarinefirefightingsystemsduringanemergencywhenastrickenshiphasasystemfailure.1.2Internationalshoreconnectionsareportableuniversalcouplingsthatpermitconnectionofshipboardfiremainsystemsbetweenoneshipandanotherorbetweenashorefacilityandashipwhentheirrespectivesystemthreadingismismatched.Boththeshipandthefacilityareexpectedtohaveafittingsuchthatinanemergencycanbeattachedtotheirrespectivefirehoseandboltedtogethertopermitchargingtheship'ssystem.Itmustbeportabletoaccommodatehosetohoseconnectionandallowassistancefromanyposition.1.3Theinternationalshoreconnectionisrequiredbyinternationaltreaty,tobecarriedonboardallpassengerandcargovesselsof500grosstonsormore,regardlessoffiremainsize,engagedininternationalvoyages,andisrecommendedforallvesselsthatwouldbeexpectedtorenderassistance.Itisalsointendedtobeprovidedatshorefacilitiesthatwouldbeusedtosupplywatertoaship'sfiremainsystem.1.4Fabricationeitheronboardavessel,inashipyard,orothershorefacilityisnotprecludedbythisspecification.1.5Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.
【中国标准分类号】:U66
【国际标准分类号】:47_020_30
【页数】:3P.;A4
【正文语种】:
【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】:StandardSpecificationforInternationalShoreConnectionsforMarineFireApplications
【原文标准名称】:船舶灭火用国际海岸通讯线
【标准号】:ASTMF1121-1987(2004)
【标准状态】:现行
【国别】:
【发布日期】:1987
【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】:F25.11
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:导航;火灾;无线电电路;国际的;海岸
【英文主题词】:firefightingsystems;internationalshoreconnections;hose-to-hoseconnection;marinefireapplications;portableuniversalcouplings;shipboardfiremainsystems;strickenship
【摘要】:1.1Thisspecificationcoversthedesignandmanufactureofinternationalshoreconnectionstobeusedwithmarinefirefightingsystemsduringanemergencywhenastrickenshiphasasystemfailure.1.2Internationalshoreconnectionsareportableuniversalcouplingsthatpermitconnectionofshipboardfiremainsystemsbetweenoneshipandanotherorbetweenashorefacilityandashipwhentheirrespectivesystemthreadingismismatched.Boththeshipandthefacilityareexpectedtohaveafittingsuchthatinanemergencycanbeattachedtotheirrespectivefirehoseandboltedtogethertopermitchargingtheship'ssystem.Itmustbeportabletoaccommodatehosetohoseconnectionandallowassistancefromanyposition.1.3Theinternationalshoreconnectionisrequiredbyinternationaltreaty,tobecarriedonboardallpassengerandcargovesselsof500grosstonsormore,regardlessoffiremainsize,engagedininternationalvoyages,andisrecommendedforallvesselsthatwouldbeexpectedtorenderassistance.Itisalsointendedtobeprovidedatshorefacilitiesthatwouldbeusedtosupplywatertoaship'sfiremainsystem.1.4Fabricationeitheronboardavessel,inashipyard,orothershorefacilityisnotprecludedbythisspecification.1.5Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.
【中国标准分类号】:U66
【国际标准分类号】:47_020_30
【页数】:3P.;A4
【正文语种】:
