標準號：DIN EN ISO 11138-2-2009
中文標準名稱：保健產品的滅菌.生物指示劑.第2部分:環氧乙烷滅菌過程的生物指示器(ISO 11138-2-2006).英文版本DIN EN ISO 11138-2-2009-09
英文標準名稱：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
標準類型：C05
發布日期：1999/12/31 12:00:00
實施日期：2009/9/1 12:00:00
中國標準分類號：C05
國際標準分類號：11.080.20
引用標準：ISO 11138-1-2006;ISO 18472
適用范圍：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 andsterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxidegas 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.