BS EN ISO 11138-2-2009 医疗保健产品灭菌.生物指示剂.环氧乙烷灭菌用生物指示剂

标准号：BS EN ISO 11138-2-2009
中文标准名称：医疗保健产品灭菌.生物指示剂.环氧乙烷灭菌用生物指示剂
英文标准名称：Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes
标准类型：C05
发布日期：2009/11/30 12:00:00
实施日期：2009/11/30 12:00:00
中国标准分类号：C05
国际标准分类号：11.080.20
引用标准：ISO 11138-1-2006;ISO 18472
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 oxidegas 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.