BS EN ISO 11737-2-2009 医疗器械的消毒.微生物学法.灭菌过程的定义、有效性和维护中进行的无菌试验

标准号：BS EN ISO 11737-2-2009
中文标准名称：医疗器械的消毒.微生物学法.灭菌过程的定义、有效性和维护中进行的无菌试验
英文标准名称：Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
标准类型：C30
发布日期：2010/3/31 12:00:00
实施日期：2010/3/31 12:00:00
中国标准分类号：C30
国际标准分类号：07.100.10;11.080.01
引用标准：ISO 10012;ISO 11737-1-2006;ISO 13845-2003;ISO/IEC 17025-2005
适用范围：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.