标准号：ISO 11138-3-2006
实施状态：作废
中文名称：医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌用生物指示剂
英文名称：Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
发布日期：2006-07
被替代标准：ISO 11138-3-2017
代替标准：ISO 11138-3-1995;ISO/FDIS 11138-3-2006
采用标准：DIN EN ISO 11138-3-2006,IDT;DIN EN ISO 11138-3-2009,IDT;DIN EN ISO 11138-3/A1-2009,IDT;ANSI/AAMI/ISO 11138-3-2006,IDT;BS EN ISO 11138-3-2006,IDT;BS EN ISO 11138-3-2009,IDT;EN ISO 11138-3-2006,IDT;EN ISO 11138-3-2009,IDT;prEN ISO 11138-3-2008,IDT;NF S98-004-3-2006,IDT;NF S98-004-3-2009,IDT;S98-004-3PR,IDT;SN EN ISO 11138-3-2006,IDT;SN EN ISO 11138-3-2009,IDT;OENORM EN ISO 11138-3-2006,IDT;OENORM EN ISO 11138-3-2009,IDT;PN-EN ISO 11138-3-2006,IDT;PN-EN ISO 11138-3-2008,IDT;PN-EN ISO 11138-3-2009,IDT;UNE-EN ISO 11138-3-2007,IDT;UNE-EN ISO 11138-3-2009,IDT
起草单位：ISO/TC 198
标准简介：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.
文件格式：PDF
文件大小：189.05KB
文件页数：14
（以上信息更新时间为：2019-11-22）
ISO 11138-3-2006 医疗保健产品灭菌.生物指示物.第3部分_湿热灭菌用生物指示剂.pdf
(189.05 KB)
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