ASTM D7102-2004 测定无菌医疗手套的内毒素的标准指南

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【英文标准名称】:StandardGuideforDeterminationofEndotoxinonSterileMedicalGloves
【原文标准名称】:测定无菌医疗手套的内毒素的标准指南
【标准号】:ASTMD7102-2004
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:手套;无菌;医疗的;内毒素;测定
【英文主题词】:endotoxin;gloves;lipopolysaccharide;LPS;non-pyrogenic;pyrogenic
【摘要】:1.1Thisguidecoversaselectionofmethodologiesforthedeterminationofbacterialendotoxinongloveswhensuchadeterminationisappropriate.1.2Asbacteriamaycontinuetogrowonnon-sterilegloves,reportableendotoxinlevelsareonlyappropriateforsterilegloves.1.3Thisguideisnotapplicabletothedeterminationofpyrogensotherthanbacterialendotoxins.1.4Thesamplepreparationmethoddescribedmustbeusedregardlessofthetestmethodselected.Thismethoddoesnotdescribelaboratorytestmethodvalidation,analystqualification,orreagentconfirmation.Product-specificvalidationisaddressed.1.5Thesafeandproperuseofmedicalglovesisbeyondthescopeofthisguide.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:G45
【国际标准分类号】:11_140
【页数】:5P.;A4
【正文语种】: