DIN EN ISO 11138-2:2009
保健产品的灭菌.生物指示剂.第2部分:环氧乙烷灭菌过程的生物指示器(ISO 11138-2-2006).英文版本DIN EN ISO 11138-2-2009-09

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); English version of DIN EN ISO 11138-2:2009-09

被代替

标准号

DIN EN ISO 11138-2:2009

发布

2009年

发布单位

德国标准化学会

替代标准

DIN EN ISO 11138-2:2017

当前最新

DIN EN ISO 11138-2:2017

 

 

引用标准

ISO 11138-1:2006 ISO 18472

被代替标准

DIN EN ISO 11138-2:2006 DIN EN ISO 11138-2/A1:2009

适用范围

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℃ to 65℃. 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.

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