标准号：ISO 11137-2-2006
实施状态：作废
中文名称：保健产品的灭菌.辐射.第2部分:确定杀菌剂量
英文名称：Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
发布日期：2006-04
被替代标准：ISO 11137-2-2012
代替标准：ISO 11137-1995;ISO 11137 Technical Corrigendum 1-1997;ISO 11137 AMD 1-2001;ISO/FDIS 11137-2-2006
采用标准：DIN EN ISO 11137-2-2006,IDT;DIN EN ISO 11137-2-2007,IDT;DIN EN ISO 11137-2-2004,IDT;DIN EN ISO 11137-2-2007,IDT;ANSI/AAMI/ISO 11137-2-2006,IDT;BS EN ISO 11137-2-2007,IDT;EN ISO 11137-2-2006,IDT;EN ISO 11137-2-2007,IDT;prEN ISO 11137-2-2007,IDT;NF S98-103-2-2006,IDT;NF S98-103-2-2008,IDT;JIS T 0806-2-2010,IDT;CAN/CSA-Z11137-2-07-2007,IDT;SN EN ISO 11137-2-2006,IDT;SN EN ISO 11137-2-2007,IDT;OENORM EN ISO 11137-2-2006,IDT;OENORM EN ISO 11137-2-2007,IDT;OENORM EN ISO 11137-2-2007,IDT;PN-EN ISO 11137-2-2006,IDT;PN-EN ISO 11137-2-2007,IDT;PN-EN ISO 11137-2-2007,IDT;UNE-EN ISO 11137-2-2007,IDT;GOST R ISO 11137-2-2008,IDT
起草单位：ISO/TC 198
标准简介：This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified
requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to
achieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also specifies methods of dose
auditing in order to demonstrate the continued effectiveness of the sterilization dose.
This part of ISO 11137 defines product families for dose establishment and dose auditing.
文件格式：PDF
文件大小：501.04KB
文件页数：68
（以上信息更新时间为：2019-11-22）
ISO 11137-2-2006 保健产品的灭菌.辐射.第2部分_确定杀菌剂量.pdf
(501.04 KB)
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