标准编号：ISO 11140-1:2014
中文名称：医疗保健产品的灭菌 化学指示剂 第1部分：通用要求
英文名称：Sterilization of health care products — Chemical indicators — Part 1: General requirements
发布日期：2014-11
标准范围
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposureto sterilization processes by means of physical and/or chemical change of substances, and which areused to monitor the attainment of one or more of the process parameter(s) specified for a sterilizationprocess. They are not dependent for their action on the presence or absence of a living organism.NOTE 1 Biological test systems are regarded as those test systems which are dependent for their interpretationon 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 insubsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, inwhich case the requirement of that particular part will apply.Relevant test equipment is described in ISO 18472.NOTE 2 Additional requirements for specific test indicators/indicator systems (Type 2 indicators) are given inISO 11140-3, ISO 11140-4 and ISO 11140-5.
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