【英文标准名称】:Sterilizationofmedicaldevices-Microbiologicalmethods-Testsofsterilityperformedinthevalidationofasterilizationprocess
【原文标准名称】:医疗器械的消毒.微生物学法.确认灭菌过程中的无菌检验
【标准号】:BSENISO11737-2-2000
【标准状态】:作废
【国别】:英国
【发布日期】:2000-05-15
【实施或试行日期】:2000-05-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:试样制备;产品;试验设备;估计可靠性;无菌设备;生物分析和试验;微生物学;过程控制;试样;认可试验;医疗设备;灭菌
【英文主题词】:Bioassay;Components;Definitions;Medicaldevices;Medicalequipment;Medicalproducts;Microbiology;Packages;Rawmaterial;Sterility;Sterilization(hygiene);Testing;Validation
【摘要】:1ThispartofISO11737specifiesthegeneralcriteriafortestsofsterilityonmedicaldeviceswhichhavebeenexposedtoatreatmentwiththesterilizingagentthatisafractionofthespecifiedsterilizationprocess.Thesetestsareintendedtobeperformedwhenvalidatingasterilizationprocess.2ThispartofISO11737isnotapplicableto:a)sterilitytestingforroutinereleaseofproductthathasbeensubjectedtoasterilizationprocess;b)performanceofapharmacopoeialtestforsterility;orNOTE1Theperformanceofa)orb)aboveisnotarequirementofISO11134,11135or11137.c)culturingofbiologicalindicators,includinginoculatedproducts.NOTE2MethodsofculturingbiologicalindicatorsaredescribedinISO11138.
【中国标准分类号】:C05
【国际标准分类号】:07_100_10;11_080_01
【页数】:24P.;A4
【正文语种】:英语