ASTM F1886-1998(2004) 用目视检验测定医疗包装密封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】:用目视检验测定医疗包装密封完整性的标准试验方法
【标准号】:ASTMF1886-1998(2004)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:通道;点状密封;无菌包装完整性;目视密封检验;医疗包装;最小密封宽度
【英文主题词】:channels;medicalpackaging;minimumsealwidth;spottyseals;sterilepackageintegrity;visualsealinspection
【摘要】:Sealattributescanbelinkeddirectlytoanumberofvariablesinprocessparameters,equipment,ormaterial,aswellasenvironmental(roomtemperatureandrelativehumidity).Visualsealcharacteristicsanddefectscanprovideevidenceofsterilepackageintegrityandproductionsealingproblems.Visualsealdefectsoftenwillbethefirstindicationofheatsealingprocessvariation.Theyalsowillindicatealackof,orpotentialcompromiseto,packageintegrityafterphysicalpackageperformancetesting.1.1Thistestmethodcoversthedeterminationofchannelsinthepackagesealdowntoawidthof75956;m(0.003in.)witha60-100%probability(seeSection8).1.1.1Theabilitytovisuallydetectchanneldefectsinpackagesealsishighlydependentonthesizeofchannel,thedegreeofcontrastfromsealedandunsealedareas,theamountandtypeofadhesivebetweenthetwopackagelayers,reflectinglightangle,typesofmaterialused,theuseofmagnification,andtheinspector'sleveloftrainingandexperience.1.2Thistestmethodisapplicabletoflexibleandrigidpackageswithatleastonetransparentsidesothatthesealareamaybeclearlyviewed.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:55_040
【页数】:4P.;A4
【正文语种】:
【原文标准名称】:用目视检验测定医疗包装密封完整性的标准试验方法
【标准号】:ASTMF1886-1998(2004)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:通道;点状密封;无菌包装完整性;目视密封检验;医疗包装;最小密封宽度
【英文主题词】:channels;medicalpackaging;minimumsealwidth;spottyseals;sterilepackageintegrity;visualsealinspection
【摘要】:Sealattributescanbelinkeddirectlytoanumberofvariablesinprocessparameters,equipment,ormaterial,aswellasenvironmental(roomtemperatureandrelativehumidity).Visualsealcharacteristicsanddefectscanprovideevidenceofsterilepackageintegrityandproductionsealingproblems.Visualsealdefectsoftenwillbethefirstindicationofheatsealingprocessvariation.Theyalsowillindicatealackof,orpotentialcompromiseto,packageintegrityafterphysicalpackageperformancetesting.1.1Thistestmethodcoversthedeterminationofchannelsinthepackagesealdowntoawidthof75956;m(0.003in.)witha60-100%probability(seeSection8).1.1.1Theabilitytovisuallydetectchanneldefectsinpackagesealsishighlydependentonthesizeofchannel,thedegreeofcontrastfromsealedandunsealedareas,theamountandtypeofadhesivebetweenthetwopackagelayers,reflectinglightangle,typesofmaterialused,theuseofmagnification,andtheinspector'sleveloftrainingandexperience.1.2Thistestmethodisapplicabletoflexibleandrigidpackageswithatleastonetransparentsidesothatthesealareamaybeclearlyviewed.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:55_040
【页数】:4P.;A4
【正文语种】:
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