标准号：ISO 11138-1-2006
实施状态：作废
中文名称：医疗保健产品灭菌.生物指示物.第1部分:一般要求
英文名称：Sterilization of health care products - Biological indicators - Part 1: General requirements
发布日期：2006-07
被替代标准：ISO 11138-1-2017
代替标准：ISO 11138-1-1994;ISO/FDIS 11138-1-2006
采用标准：DIN EN ISO 11138-1-2006,IDT;ANSI/AAMI/ISO 11138-1-2006,IDT;BS EN ISO 11138-1-2006,IDT;EN ISO 11138-1-2006,IDT;NF S98-004-1-2006,IDT;CAN/CSA-Z11138-1-07-2007,IDT;SN EN ISO 11138-1-2006,IDT;OENORM EN ISO 11138-1-2006,IDT;PN-EN ISO 11138-1-2006,IDT;PN-EN ISO 11138-1-2008,IDT;UNE-EN ISO 11138-1-2007,IDT
起草单位：ISO/TC 198
标准简介：1.1 General
1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.
NOTE National or regional regulations may apply.
1.2 Exclusions
This part of ISO 11138 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems.
文件格式：PDF
文件大小：400.08KB
文件页数：46
（以上信息更新时间为：2019-11-22）
ISO 11138-1-2006 医疗保健产品灭菌.生物指示物.第1部分_一般要求.pdf
(400.08 KB)
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