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【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