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.
DIN EN ISO 11138-2-2009由德国标准化学会 DE-DIN 发布于 2009-09,并于 2009-09-01 实施。
DIN EN ISO 11138-2-2009 在中国标准分类中归属于: C05 医学,在国际标准分类中归属于: 11.080.20 消毒剂和防腐剂。
* 在 DIN EN ISO 11138-2-2009 发布之后有更新,请注意新发布标准的变化。
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