标准号：ISO 11138-2-2006
实施状态：作废
中文名称：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
英文名称：Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
发布日期：2006-07
被替代标准：ISO 11138-2-2017
代替标准：ISO 11138-2-1994;ISO/FDIS 11138-2-2006
采用标准：DIN EN ISO 11138-2-2006,IDT;DIN EN ISO 11138-2-2009,IDT;DIN EN ISO 11138-2/A1-2009,IDT;ANSI/AAMI/ISO 11138-2-2006,IDT;BS EN ISO 11138-2-2006,IDT;BS EN ISO 11138-2-2009,IDT;EN ISO 11138-2-2006,IDT;EN ISO 11138-2-2009,IDT;prEN ISO 11138-2-2008,IDT;NF S98-004-2-2006,IDT;NF S98-004-2-2009,IDT;S98-004-2PR,IDT;SN EN ISO 11138-2-2006,IDT;SN EN ISO 11138-2-2009,IDT;OENORM EN ISO 11138-2-2006,IDT;OENORM EN ISO 11138-2-2009,IDT;PN-EN ISO 11138-2-2006,IDT;PN-EN ISO 11138-2-2008,IDT;PN-EN ISO 11138-2-2009,IDT;UNE-EN ISO 11138-2-2007,IDT;UNE-EN ISO 11138-2-2009,IDT
起草单位：ISO/TC 198
标准简介：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.
文件格式：PDF
文件大小：164.44KB
文件页数：10
（以上信息更新时间为：2019-11-22）
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.pdf
(164.44 KB)
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