标准编号：ISO 11140-1:2005
中文名称：医疗保健产品的灭菌 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
标准范围
This part of ISO 11140 specifies general requirements and test methods for indicators that showexposure to sterilization processes by means of physical and/or chemical change of substances, and whichare used to monitor the attainment of one or more of the variables required for a sterilization process. Theyare 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 thedemonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series forbiological 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, in whichcase 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 11140-4and ISO 11140-5.
标准预览图
立即下载标准文件