標準號：DIN EN ISO 15882-2008
中文標準名稱：衛生保健產品的滅菌.化學指示劑.選擇、使用指南和要求的試驗結果(ISO 15882-2008).英文版本DIN EN ISO 15882-2008
英文標準名稱：Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); English version of DIN EN ISO 15882:2008-12
標準類型：C04
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C04
國際標準分類號：11.080.01
適用范圍：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).