ASTM F1886/F1886M-2009 目视检查测定医药包装密封件完整性的标准试验方法
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【英文标准名称】:StandardTestMethodforDeterminingIntegrityofSealsforMedicalPackagingbyVisualInspection
【原文标准名称】:目视检查测定医药包装密封件完整性的标准试验方法
【标准号】:ASTMF1886/F1886M-2009
【标准状态】:现行
【国别】:
【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】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:channels;minimumsealwidth;spottyseals;sterilepackageintegrity;visualsealinspection;Channels;Integritytesting;Medical/surgicalpackagingmaterials;Minimumsealwidth;Sealing/securingpackages/containers;Sealintegrity;Sterilemedicalde
【摘要】:Sealattributescanbelinkeddirectlytoanumberofvariablesinprocessparameters,equipment,ormaterial,aswellasenvironmental(roomtemperatureandrelativehumidity).Visualsealcharacteristicsanddefectscanprovideevidenceofpackageintegrityandproductionsealingproblems.Visualsealdefectsoftenwillbethefirstindicationofheatsealingprocessvariation.Theyalsowillindicatealackof,orpotentialcompromiseto,packageintegrityafterphysicalpackageperformancetesting.1.1Thistestmethodcoversthedeterminationofchannelsinthepackagesealdowntoawidthof75x03BC;m[0.003in.]witha60x2013;100%probability(seeSection8).1.1.1Theabilitytovisuallydetectchanneldefectsinpackagesealsishighlydependentonthesizeofchannel,thedegreeofcontrastfromsealedandunsealedareas,theamountandtypeofadhesivebetweenthetwopackagelayers,reflectinglightangle,typesofmaterialused,theuseofmagnification,andtheinspector''sleveloftrainingandexperience.1.2Thistestmethodisapplicabletopackageswithatleastonetransparentsidesothatthesealareamaybeclearlyviewed.1.3ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:
【国际标准分类号】:55_040
【页数】:4P.;A4
【正文语种】:
【原文标准名称】:目视检查测定医药包装密封件完整性的标准试验方法
【标准号】:ASTMF1886/F1886M-2009
【标准状态】:现行
【国别】:
【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】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:channels;minimumsealwidth;spottyseals;sterilepackageintegrity;visualsealinspection;Channels;Integritytesting;Medical/surgicalpackagingmaterials;Minimumsealwidth;Sealing/securingpackages/containers;Sealintegrity;Sterilemedicalde
【摘要】:Sealattributescanbelinkeddirectlytoanumberofvariablesinprocessparameters,equipment,ormaterial,aswellasenvironmental(roomtemperatureandrelativehumidity).Visualsealcharacteristicsanddefectscanprovideevidenceofpackageintegrityandproductionsealingproblems.Visualsealdefectsoftenwillbethefirstindicationofheatsealingprocessvariation.Theyalsowillindicatealackof,orpotentialcompromiseto,packageintegrityafterphysicalpackageperformancetesting.1.1Thistestmethodcoversthedeterminationofchannelsinthepackagesealdowntoawidthof75x03BC;m[0.003in.]witha60x2013;100%probability(seeSection8).1.1.1Theabilitytovisuallydetectchanneldefectsinpackagesealsishighlydependentonthesizeofchannel,thedegreeofcontrastfromsealedandunsealedareas,theamountandtypeofadhesivebetweenthetwopackagelayers,reflectinglightangle,typesofmaterialused,theuseofmagnification,andtheinspector''sleveloftrainingandexperience.1.2Thistestmethodisapplicabletopackageswithatleastonetransparentsidesothatthesealareamaybeclearlyviewed.1.3ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:
【国际标准分类号】:55_040
【页数】:4P.;A4
【正文语种】:
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