ISO 11138-2-2006 医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂

标准号：ISO 11138-2-2006
中文标准名称：医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂
英文标准名称：Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
标准类型：C47
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.01;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 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.