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【英文标准名称】:Agriculturalandforestrytractorsandmachinery.Technicalmeansforprovidingsafety.Part16:equipmentforvinecultivation.
【原文标准名称】:农林用拖拉机和机械.保证安全的技术手段.第16部分:葡萄树栽培用设备
【标准号】:NFU02-016-1987
【标准状态】:现行
【国别】:法国
【发布日期】:1987-12-01
【实施或试行日期】:1987-12-20
【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】:安全要求;农用设备;农业机械;安全装置;事故预防;防护电气设备;规范;葡萄园和葡萄洒酿造用设备;葡萄园用设备;安全措施;图表;防护等级
【英文主题词】:
【摘要】:
【中国标准分类号】:B91
【国际标准分类号】:65_060_50;65_060_60
【页数】:4P;A4
【正文语种】:其他


【英文标准名称】:StandardGuideforDesignandEvaluationofPrimaryFlexiblePackagingforMedicalProducts
【原文标准名称】:医用产品用一级软包装的设计和评估标准指南
【标准号】:ASTMF2097-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:F02.50
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:Design;Flexiblepackagingmaterials;Medical/surgicalpackagingmaterials
【摘要】:Thisdesignandevaluationguidedescribesmultiplecategoriesforevaluatingflexiblemedicalpackagesandpackagingmaterials.Theseincludesafety,barrierproperties,durability,packageandsealintegrity,visibilityandappearance,processing,printinginkproperties,andpackageperformance.Theintentofthisdesignandevaluationguideistoevaluateallcitedcategoriesandselectthosethatareapplicable.Oncetheproducthasbeencharacterizedandthesterilizationmethodologyhasbeendefined,therearenumeroussetsofrequirementsforanyspecificpackage.Thisdesignandevaluationguideprovidesanavenueforassessingtheserequirementsandchoosingtestmethodsforbothevaluatingthepackagedesignandmonitoringpackagecompliance.Note18212;ManyofthestandardsincludedinthisguideareconsensusstandardsthatarerecognizedbytheUnitedStatesFoodandDrugAdministration(FDA).SelectionanduseofaU.S.FDArecognizedconsensusstandardisvoluntaryandthesoleresponsibilityoftheuserindeterminingitsapplicability.Forfurtherinformation,consulttheU.S.FDAMedicalDeviceStandardsProgramathttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.Productcharacterizationshallincludemassorweight,geometry(lengthandwidth,height,andshape)andproductcomposition.Allcategoriesmustbeconsideredforapplicability.TheSummaryofTestMethodsforMedicalPackagingDesignandEvaluation(Fig.1)providesacompactgraphicalpresentationofthetestmethodsreferencedinthisguide.TestDescriptionandApplicability(seeTable1):Table1liststhetestmethodscommonlyusedtoevaluateflexiblemedicalpackaging.Thetestmethodsareusedintwophases.PackageDesign:CharacterizationoftheMaterialsandEvaluationoftheResultantPackage8212;Thisisreferredtoasx201C;Rx0026;DEvaluationx201D;inTable1.Testingduringthisphaseischaracterizedbythegenerationofquantitativedataontheperformanceofthecomponentmaterialsandthepackageassembly.Thesetestmethodsarelengthy,makingtheminappropriateforthemanufacturingenvironmentwhererapidresponseisrequiredforprocesscontrol.Often,theyareexpensiveandrequirespecializedequipmentnotreadilyavailableatamedicalpackagingordevicemanufacturingfacility.PackageCompliance:RoutineMonitoringofAdherencetoSpecifications8212;Thisisreferredtoasx201C;ComplianceTestingx201D;inTable1.Testingduringthisphasemustberapid,inexpensive,andreadilyimplementedinamanufacturingenvironment.Theobjectiveisnottodevelopdesigndata,buttoensurethatthedesignspecificationsarebeingmet.Thesetestmethodsdonotnecessarilymakedirectmeasurementsofcriticalvalues,butdetectvariationsinmaterial,process,orproductthatareindicativeofallcriticalcharacteristics.Itisimportanttonotethatnoindividualtestmethodisentirelypredictiveoffinalpackageperformance.Filledpackagesmustbeevaluatedunderconditionsofuse.Oncethedesignofthepackageand/orpackagingmaterialshasbeendetermined,itmaybeappropriatetocreateapackageand/ormaterialspecification.GuidesF99orF2559mayprovideusefulguidance.1.1Thisguideprovidesdirec......
【中国标准分类号】:C08
【国际标准分类号】:55_020
【页数】:17P.;A4
【正文语种】:英语