ISO 11138-3-2006 医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌用生物指示剂
作者:标准资料网 时间:2024-05-11 13:04:44 浏览:9008
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Sterilizationofhealthcareproducts-Biologicalindicators-Part3:Biologicalindicatorsformoistheatsterilizationprocesses
【原文标准名称】:医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌用生物指示剂
【标准号】:ISO11138-3-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-07
【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】:细菌计数;生物测定;生物化学制品;生物指示剂;生物分析和试验;生物试验;湿热试验;效率;评定;细菌;加热消毒;指示器;医疗设备;医学科学;方法;微生物分析;微生物;公共卫生;耐力;规范;规范(验收);蒸汽;蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;杀菌器具;系统;实验细菌;试验
【英文主题词】:Bacterialcount;Bioassay;Biochemicals;Bio-indicators;Biologicalanalysisandtesting;Biologicalhazards;Biologicalsystems;Biologicaltests;Damp-heattests;Efficiency;Evaluations;Germs;Heat;Heatsterilization;Indicators;Inoculation;Markingofroads;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methods;Microbiologicalanalysis;Microorganisms;Operation;Packages;Population;Publichealth;Qualifications;Ratingtests;Resistance;Sequenceofoperations;Specification;Specification(approval);Steam;Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Sterilizinggases;Surveillance(approval);Survivalcharacteristics;Systems;Testgerms;Testing;Use;Validation;Vapours
【摘要】:ThispartofISO11138providesspecificrequirementsfortestorganisms,suspensions,inoculatedcarriers,biologicalindicatorsandtestmethodsintendedforuseinassessingtheperformanceofsterilizationprocessesemployingmoistheatasthesterilizingagent.MoistheatasthesterilizingagentisdefinedinthispartofISO11138asdrysaturatedsteam.Whileair-steammixturesmaybeusedinmoistheatsterilizationprocesses,themethodsandperformancerequirementsofthispartofISO11138mightnotbeapplicableforbiologicalindicatorsusedinsuchprocesses.NOTE1RequirementsforvalidationandcontrolofmoistheatsterilizationprocessesareprovidedbyISO17665.NOTE2Nationalorregionalregulationsmayproviderequirementsforworkplacesafety.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01;11_080_20
【页数】:8P;A4
【正文语种】:英语
【原文标准名称】:医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌用生物指示剂
【标准号】:ISO11138-3-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-07
【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】:细菌计数;生物测定;生物化学制品;生物指示剂;生物分析和试验;生物试验;湿热试验;效率;评定;细菌;加热消毒;指示器;医疗设备;医学科学;方法;微生物分析;微生物;公共卫生;耐力;规范;规范(验收);蒸汽;蒸汽灭菌;蒸汽灭菌器;灭菌;灭菌器;杀菌器具;系统;实验细菌;试验
【英文主题词】:Bacterialcount;Bioassay;Biochemicals;Bio-indicators;Biologicalanalysisandtesting;Biologicalhazards;Biologicalsystems;Biologicaltests;Damp-heattests;Efficiency;Evaluations;Germs;Heat;Heatsterilization;Indicators;Inoculation;Markingofroads;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methods;Microbiologicalanalysis;Microorganisms;Operation;Packages;Population;Publichealth;Qualifications;Ratingtests;Resistance;Sequenceofoperations;Specification;Specification(approval);Steam;Steamsterilization;Steamsterilizers;Sterilization(hygiene);Sterilizers;Sterilizingapparatus;Sterilizinggases;Surveillance(approval);Survivalcharacteristics;Systems;Testgerms;Testing;Use;Validation;Vapours
【摘要】:ThispartofISO11138providesspecificrequirementsfortestorganisms,suspensions,inoculatedcarriers,biologicalindicatorsandtestmethodsintendedforuseinassessingtheperformanceofsterilizationprocessesemployingmoistheatasthesterilizingagent.MoistheatasthesterilizingagentisdefinedinthispartofISO11138asdrysaturatedsteam.Whileair-steammixturesmaybeusedinmoistheatsterilizationprocesses,themethodsandperformancerequirementsofthispartofISO11138mightnotbeapplicableforbiologicalindicatorsusedinsuchprocesses.NOTE1RequirementsforvalidationandcontrolofmoistheatsterilizationprocessesareprovidedbyISO17665.NOTE2Nationalorregionalregulationsmayproviderequirementsforworkplacesafety.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01;11_080_20
【页数】:8P;A4
【正文语种】:英语
下载地址: 点击此处下载
