DIN EN ISO 11737-1-2009 医疗设备的消毒.微生物法.第1部分:产品上微生物群落的测定(ISO11737-1-2006)(包括勘误表AC-2009).英文版本DINENISO11737-1-2009-09
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【英文标准名称】:Sterilizationofmedicaldevices-Microbiologicalmethods-Part1:Determinationofapopulationofmicroorganismsonproducts(ISO11737-1:2006)(includesCorrigendumAC:2009);EnglishversionofDINENISO11737-1:2009-09
【原文标准名称】:医疗设备的消毒.微生物法.第1部分:产品上微生物群落的测定(ISO11737-1-2006)(包括勘误表AC-2009).英文版本DINENISO11737-1-2009-09
【标准号】:DINENISO11737-1-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:分析;应用;评定;细菌纲;细菌计数;细菌学质量;生物危害;特征;菌落计数;浓缩;条件;污染;修正;计数;文化;培养基;定义(术语);测定;电子数据处理(EDP);选举;设备;估计;评估;过滤;病菌;指导手册;卫生学;潜伏;检验;仪器;实验室;实验室测试;极限(数学);负荷;材料;数学计算;介质;医疗设备;医疗器材;医疗器械;医疗产品;医学科学;薄膜材料;方法;生产方法;微生物的;微生物分析;微生物学;微小生物;微生物;操作;包装件;式样;全体人员;人口;产品;质量保证;质量管理;原材料;收回;释放;安全性;样品;抽样方法;选择;溶液;规范(验收);消毒;无菌;灭菌;物质;测试;传递;运输;处理;证实;验证
【英文主题词】:Analysis;Applications;Assessment;Bacteria;Bacterialcount;Bacteriologicalquality;Biologicalhazards;Characteristics;Colonycount;Concentration;Conditions;Contamination;Corrrections;Counting;Culture;Culturemedia;Definitions;Determination;EDP;Elections;Equipment;Estimation;Evaluations;Filtration;Germs;Guidebooks;Hygiene;Incubation;Inspection;Instruments;Laboratories;Laboratorytesting;Limits(mathematics);Loading;Materials;Mathematicalcalculations;Media;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Membranes;Methods;Methodsofmanufacture;Microbiological;Microbiologicalanalysis;Microbiology;Micro-organisms;Microorganisms;Operation;Packages;Patterns;Personnel;Population;Products;Qualityassurance;Qualitymanagement;Rawmaterials;Reclamation;Release;Safety;Samples;Samplingmethods;Selection;Solutions;Specification(approval);Sterile;Sterility;Sterilization(hygiene);Substances;Testing;Transfer;Transport;Treatment;Validation;Verification
【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】:45P.;A4
【正文语种】:英语
【原文标准名称】:医疗设备的消毒.微生物法.第1部分:产品上微生物群落的测定(ISO11737-1-2006)(包括勘误表AC-2009).英文版本DINENISO11737-1-2009-09
【标准号】:DINENISO11737-1-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:分析;应用;评定;细菌纲;细菌计数;细菌学质量;生物危害;特征;菌落计数;浓缩;条件;污染;修正;计数;文化;培养基;定义(术语);测定;电子数据处理(EDP);选举;设备;估计;评估;过滤;病菌;指导手册;卫生学;潜伏;检验;仪器;实验室;实验室测试;极限(数学);负荷;材料;数学计算;介质;医疗设备;医疗器材;医疗器械;医疗产品;医学科学;薄膜材料;方法;生产方法;微生物的;微生物分析;微生物学;微小生物;微生物;操作;包装件;式样;全体人员;人口;产品;质量保证;质量管理;原材料;收回;释放;安全性;样品;抽样方法;选择;溶液;规范(验收);消毒;无菌;灭菌;物质;测试;传递;运输;处理;证实;验证
【英文主题词】:Analysis;Applications;Assessment;Bacteria;Bacterialcount;Bacteriologicalquality;Biologicalhazards;Characteristics;Colonycount;Concentration;Conditions;Contamination;Corrrections;Counting;Culture;Culturemedia;Definitions;Determination;EDP;Elections;Equipment;Estimation;Evaluations;Filtration;Germs;Guidebooks;Hygiene;Incubation;Inspection;Instruments;Laboratories;Laboratorytesting;Limits(mathematics);Loading;Materials;Mathematicalcalculations;Media;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Membranes;Methods;Methodsofmanufacture;Microbiological;Microbiologicalanalysis;Microbiology;Micro-organisms;Microorganisms;Operation;Packages;Patterns;Personnel;Population;Products;Qualityassurance;Qualitymanagement;Rawmaterials;Reclamation;Release;Safety;Samples;Samplingmethods;Selection;Solutions;Specification(approval);Sterile;Sterility;Sterilization(hygiene);Substances;Testing;Transfer;Transport;Treatment;Validation;Verification
【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】:45P.;A4
【正文语种】:英语
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