ISO 11140-1-2005 保健产品的灭菌.化学指示剂.第1部分_一般要求.pdf

标准号：ISO 11140-1-2005
实施状态：作废
中文名称：保健产品的灭菌.化学指示剂.第1部分:一般要求
英文名称：Sterilization of health care products - Chemical indicators - Part 1: General requirements
发布日期：2005-07
被替代标准：ISO 11140-1-2014
代替标准：ISO 11140-1-1995;ISO/FDIS 11140-1-2005;ISO 11140-1 AMD 1-1998
采用标准：DIN EN ISO 11140-1-2006,IDT;DIN EN ISO 11140-1-2009,IDT;DIN EN ISO 11140-1/A1-2009,IDT;ANSI/AAMI/ISO 11140-1-2005,IDT;BS EN ISO 11140-1-2006,IDT;BS EN ISO 11140-1-2009,IDT;EN ISO 11140-1-2005,IDT;EN ISO 11140-1-2009,IDT;prEN ISO 11140-1-2008,IDT;NF S98-001-1-2005,IDT;NF S98-001-1-2009,IDT;S98-001-1PR,IDT;SN EN ISO 11140-1-2006,IDT;SN EN ISO 11140-1-2009,IDT;OENORM EN ISO 11140-1-2006,IDT;OENORM EN ISO 11140-1-2007,IDT;OENORM EN ISO 11140-1-2009,IDTN-EN ISO 11140-1-2005,IDTN-EN ISO 11140-1-2006,IDTN-EN ISO 11140-1-2009,IDT;UNE-EN ISO 11140-1-2006,IDT;UNE-EN ISO 11140-1-2009,IDT;GOST R ISO 11140-1-2009,IDT
起草单位：ISO/TC 198
标准简介：This part of ISO 11140 specifies general requirements and test methods for indicators that show
exposure to sterilization processes by means of physical and/or chemical change of substances, and which
are used to monitor the attainment of one or more of the variables required for a sterilization process. They
are not dependent for their action on the presence or absence of a living organism.
NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the
demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for
biological indicators (BIs).
The requirements and test methods of this part of ISO 11140 apply to all indicators specified in
subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which
case the requirement of that particular part will apply.
Relevant test equipment is described in ISO 18472.
NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4
and ISO 11140-5.
文件格式：PDF
文件大小：317.66KB
文件页数：34
（以上信息更新时间为：2019-11-22）



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