標準號：BS EN ISO 11737-2-2009
中文標準名稱：醫療器械的消毒.微生物學法.滅菌過程的定義、有效性和維護中進行的無菌試驗
英文標準名稱：Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
標準類型：C30
發布日期：2010/3/31 12:00:00
實施日期：2010/3/31 12:00:00
中國標準分類號：C30
國際標準分類號：07.100.10;11.080.01
引用標準：ISO 10012;ISO 11737-1-2006;ISO 13845-2003;ISO/IEC 17025-2005
適用范圍：This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that havebeen exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routinesterilization processing. These tests are intended to be performed when defining, validating or maintaining asterilization process.