ISO 11737-1-2006 医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定
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【英文标准名称】:Sterilizationofmedicaldevices-Microbiologicalmethods-Part1:Determinationofapopulationofmicroorganismsonproducts
【原文标准名称】:医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定
【标准号】:ISO11737-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-04
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【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;特性;污染;计数;定义;测定;估计;卫生学;检验;医疗设备;医疗器械;医疗产品;医学科学;微生物分析;微生物;包装件;种群;质量保证;质量管理;原材料;安全;规范(验收);无菌;灭菌;证实
【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.ThispartofISO11737doesnotspecifyrequirementsfortheenumerationoridentificationofviralorprotozoancontaminants.ThispartofISO11737doesnotspecifyrequirementsforthemicrobiologicalmonitoringoftheenvironmentinwhichmedicaldevicesaremanufactured.
【中国标准分类号】:C30
【国际标准分类号】:07_100_10;11_080_01
【页数】:35P;A4
【正文语种】:英语
【原文标准名称】:医疗器械灭菌.微生物学方法.第1部分:产品上微生物群落的测定
【标准号】:ISO11737-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-04
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【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;特性;污染;计数;定义;测定;估计;卫生学;检验;医疗设备;医疗器械;医疗产品;医学科学;微生物分析;微生物;包装件;种群;质量保证;质量管理;原材料;安全;规范(验收);无菌;灭菌;证实
【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.ThispartofISO11737doesnotspecifyrequirementsfortheenumerationoridentificationofviralorprotozoancontaminants.ThispartofISO11737doesnotspecifyrequirementsforthemicrobiologicalmonitoringoftheenvironmentinwhichmedicaldevicesaremanufactured.
【中国标准分类号】:C30
【国际标准分类号】:07_100_10;11_080_01
【页数】:35P;A4
【正文语种】:英语
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