BS EN ISO 11138-3-2009 医疗保健产品灭菌.生物指示物.湿热灭菌处理用生物指示剂

标准号：BS EN ISO 11138-3-2009
中文标准名称：医疗保健产品灭菌.生物指示物.湿热灭菌处理用生物指示剂
英文标准名称：Sterilization of health care products - Biological indicators - Biological indicators for moist heat 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 sterilization processes employing moist heat as the sterilizing agent.Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.NOTE 2 National or regional regulations may provide requirements for work place safety.