标准编号：ISO 15882:2008
中文名称：医疗保健产品的灭菌 化学指示剂 选择、使用和检验结果的解释指南
英文名称：Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
发布日期：2008-09
标准范围
1.1 This International Standard provides guidance for the selection, use and interpretation of resultsof chemical indicators used in process definition, validation and routine monitoring and overall controlof sterilization processes. This International Standard applies to indicators that show exposure tosterilization processes by means of physical and/or chemical change of substances, and which areused to monitor one or more of the variables required of a sterilization process. These chemicalindicators are not dependent for their action on the presence or absence of a living organism.1.2 This International Standard does not consider indicators for use in those processes that rely onphysical removal of microorganisms, e.g. filtration.1.3 This International Standard is not intended to apply to indicators for use in combinationprocesses, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
标准预览图
立即下载标准文件