DS/EN ISO 11138-2:2009
保健品灭菌 生物指示剂 第2部分：环氧乙烷灭菌过程的生物指示剂

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

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标准号

DS/EN ISO 11138-2:2009

发布

2009年

发布单位

丹麦标准化协会

当前最新

DS/EN ISO 11138-2:2009

 

 

被代替标准

DS/EN ISO 11138-2:2006

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 °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.

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