【英文标准名称】:Sterilizationofmedicaldevices-Microbiologicalmethods-Determinationofapopulationofmicroorganismsonproducts
【原文标准名称】:医学器材的消毒.微生物学方法.产品上微生物种群的测定
【标准号】:BSENISO11737-1-2006
【标准状态】:现行
【国别】:英国
【发布日期】:2006-04-28
【实施或试行日期】:2006-04-28
【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】:细菌纲;细菌计数;细菌学质量;特征;污染物;计数;定义;定义(术语);测定;估计;卫生学;检验;医疗设备;医疗器材;医疗器械;医疗产品;医学科学;微生物分析;微生物;包装件;居民;质量保证;质量管理;原材料;安全性;规范(验收);消毒;无菌;灭菌;有校性
【英文主题词】:Bacteria;Bacterialcount;Bacteriologicalquality;Characteristics;Contamination;Counting;Definition;Definitions;Determination;Estimation;Hygiene;Inspection;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Microbiologicalanalysis;Microorganisms;Packages;Populations;Qualityassurance;Qualitymanagement;Rawmaterials;Safety;Specification(approval);Sterile;Sterility;Sterilization(hygiene);Validation
【摘要】:ThispartofISO11737specifiesrequirementsandprovidesguidancefortheenumerationandmicrobialcharacterizationofthepopulationofviablemicroorganismsonorinamedicaldevice,component,rawmaterialorpackage.NOTE1Thenatureandextentofmicrobialcharacterizationisdependentontheintendeduseofthebioburdendata.ThispartofISO11737doesnotspecifyrequirementsfortheenumerationoridentificationofviralorprotozoancontaminants.NOTE2Furthermore,therequirementsspecifiedinthispartofISO11737arenotintendedtoaddresstheremovalanddetectionofthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldt-Jakobdisease.ThispartofISO11737doesnotspecifyrequirementsforthemicrobiologicalmonitoringoftheenvironmentinwhichmedicaldevicesaremanufactured.
【中国标准分类号】:C05
【国际标准分类号】:07_100_10;11_080_01
【页数】:48P.;A4
【正文语种】:英语


【英文标准名称】:Fibreopticinterconnectingdevicesandpassivecomponentsperformancestandard-Part061-3:SinglemodefibreopticpigtailedstyleisolatorsforcategoryU-Uncontrolledenvironment(IEC61753-061-3:2004);GermanversionEN61753-061-3:2004
【原文标准名称】:纤维光学互连器件和无源元件性能标准.第061-3部分:U类单模纤维光学有抽头的隔离器.非受控环境
【标准号】:EN61753-061-3-2004
【标准状态】:现行
【国别】:
【发布日期】:2005-04
【实施或试行日期】:2005-04-01
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:电子设备及元件;环境;绝缘子;工作性能;电气工程;紧固件;电缆;测量;定义;纤维光学;元部件;连接工艺;电插头;玻璃纤维电缆;光波导;适用性;样品尺寸;规范(验收);锐度;初始化;试验;玻璃纤维
【英文主题词】:Cables;Components;Connectiontechnology;Definition;Degreeofsharpness;Electricplugs;Electricalengineering;Electronicequipmentandcomponents;Environment;Fasteners;Fibreoptics;Fitnessforpurpose;Glassfibrecables;Glassfibres;Initialization;Insulators;Measurement;Opticalwaveguides;Performanceinservice;Samplesize;Specification(approval);Testing
【摘要】:
【中国标准分类号】:M33
【国际标准分类号】:33_180_20
【页数】:15P.;A4
【正文语种】:英语