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【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