標準號：BS EN ISO 11138-3-2009
中文標準名稱：醫療保健產品滅菌.生物指示物.濕熱滅菌處理用生物指示劑
英文標準名稱：Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
標準類型：C05
發布日期：2009/11/30 12:00:00
實施日期：2009/11/30 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 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.