【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】:


【英文标准名称】:Arc-weldedjointsinaluminiumanditsweldablealloys.Guidanceonqualitylevelsforimperfections.
【原文标准名称】:铝和可焊合金弧焊接头.质量缺陷等级导则
【标准号】:NFA89-232-1994
【标准状态】:作废
【国别】:法国
【发布日期】:1994-07-01
【实施或试行日期】:1994-07-05
【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】:气体保护焊;规范(验收);铝合金;导则;焊接接头;验收(鉴定);焊接;对接;铝;电弧焊接;角焊;等离子电弧焊;缺陷与故障;评定小组;不规则性
【英文主题词】:
【摘要】:
【中国标准分类号】:J33
【国际标准分类号】:25_160_40
【页数】:16P;A4
【正文语种】:其他