ISO 11138-2-2006 医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂

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                   【英文标准名称】:     Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes            【原文标准名称】:     医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂            【标准号】:     ISO 11138-2-2006            【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;生物系统;生物试验;效率;环氧乙烷;评定;气体灭菌器;气体;煤气;细菌;指示器;医疗设备;医学科学;方法;微生物分析;微生物;性能;规格试验;耐性;规范;规范(验收);灭菌;灭菌器;杀菌器具;灭菌气体;系统;实验细菌;试验【英文主题词】: Bacterial count;Bioassay;Biochemicals;Bio-indicators;Biological hazards;Biological systems;Biological tests;Efficiency;Ethylene oxide;Evaluations;Gas sterilizers;Gases;Germs;Indicators;Medical devices;Medical equipment;Medical products;Medical sciences;Methods;Microbiological analysis;Microorganismserformanceopulation;Rating tests;Resistance;Sequence of operations;Specification;Specification (approval);Sterilization (hygiene);Sterilizers;Sterilizing apparatus;Sterilizing gases;Survival characteristics;Systems;Test germs;Test organisms;Testing;Use【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 sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.NOTE 1      Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.NOTE 2      National or regional regulations could 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】: 5P;A4【正文语种】: 英语         
         

Leila0728

请问……这个有下载吗？

sigh007