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【英文标准名称】:StandardGuideforDeterminationofEndotoxinonSterileMedicalGloves
【原文标准名称】:测定无菌医用手套上的内毒素的标准指南
【标准号】:ASTMD7102-2010
【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】:D11.40
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:endotoxin;gloves;lipopolysaccharide;LPS;non-pyrogenic;pyrogenic;Endotoxin
【摘要】:Thisguideestablishesastandardsamplepreparationmethodandprovidesadescriptionoffourestablishedandrecognizedtestmethodsforthedeterminationofendotoxinonmedicalgloves.Ifinterferencesinasampleyieldsuspectresults,asecondmethodshouldbeused.Thisguideisappropriatefortestingfinalproductthathasbeensubjectedtoallprocessesthatcouldinfluencethefinalendotoxinlevel(eithermicrobialcontaminationorprocessingagents/rawmaterialscontaminatedwithendotoxin).Asrawmaterialsandprocessingconditionsvaryfromlottolotwithregardtotheseparameters,itisappropriatetotestforendo-toxinonaroutinebasisifaproductendotoxinclaimistobemade(forexample,non-pyrogenic).Theusermayfinditbeneficialtoincorporateendotoxintestingforvulnerableareasoftheirmanufacturingprocessasanalertmechanism.1.1Thisguidecoversaselectionofmethodologiesforthedeterminationofbacterialendotoxinongloveswhensuchadeterminationisappropriate.1.2Asbacteriamaycontinuetogrowonnon-sterilegloves,reportableendotoxinlevelsareonlyappropriateforgloveslabeledassterile.Becausemostenvironmentscontainendotoxin,onceaboxofglovesisopenedandtheglovesaremanipulated,endotoxinlevelswillincreasemakingitinappropriatetoreportendotoxinlevelsonboxedgloves(ex.examinationgloves).Thisistrueeveniftheboxhadundergonesterilizationpriortodistribution.1.3Thisguidemayalsobeappropriateforinternalqualitycontroloralertpurposesatdifferentstagesofmanufacturingorduringprocesschangeevaluations.1.4Thisguideisnotapplicabletothedeterminationofpyrogensotherthanbacterialendotoxins.1.5Thesamplepreparationmethoddescribedmustbeusedregardlessofthetestmethodselected.Thismethoddoesnotdescribelaboratorytestmethodvalidation,analystqualification,orreagentconfirmation.Product-specificvalidationisaddressed.1.6Thesafeandproperuseofmedicalglovesisbeyondthescopeofthisguide.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:11_140
【页数】:5P.;A4
【正文语种】:英语


【英文标准名称】:TestMethodforCompatibilityofMaterialswithLiquidOxygen(ImpactSensitivityThresholdandPass-FailTechniques)
【原文标准名称】:材料与液氧兼容性试验方法(冲击敏感阀与可靠性技术)
【标准号】:ASTMD2512-1982
【标准状态】:作废
【国别】:美国
【发布日期】:1982
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:ASTM
【标准类型】:()
【标准水平】:()
【中文主题词】:航空航天运输;航天技术;材料;试验;氧;兼容性;液体
【英文主题词】:testing;compatibility;liquid;materials;spacetechnology;oxygen;aerospacetransport
【摘要】:
【中国标准分类号】:G04
【国际标准分类号】:49_040_00
【页数】:17P;A4
【正文语种】:英语