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
【英文标准名称】: Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes 【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】: ISO 11138-3-2006 【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/TC 198【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】: Bacterial count;Bioassay;Biochemicals;Bio-indicators;Biological analysis and testing;Biological hazards;Biological systems;Biological tests;Damp-heat tests;Efficiency;Evaluations;Germs;Heat;Heat sterilization;Indicators;Inoculation;Marking of roads;Medical devices;Medical equipment;Medical products;Medical sciences;Methods;Microbiological analysis;Microorganisms;Operation;Packages;Population;Public health;Qualifications;Rating tests;Resistance;Sequence of operations;Specification;Specification (approval);Steam;Steam sterilization;Steam sterilizers;Sterilization (hygiene);Sterilizers;Sterilizing apparatus;Sterilizing gases;Surveillance (approval);Survival characteristics;Systems;Test germs;Testing;Use;Validation;Vapours【摘要】: This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.NOTE 2 National or regional regulations may provide requirements for work place safety.【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
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