ANSI/AAMI/ISO 11737-2-2009 医疗器械灭菌.微生物学方法.第2部分:定义、确认及维持灭菌过程中进行的无菌试验

标准号：ANSI/AAMI/ISO 11737-2-2009
中文标准名称：医疗器械灭菌.微生物学方法.第2部分:定义、确认及维持灭菌过程中进行的无菌试验
英文标准名称：Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：07.100.10;11.080.01
适用范围：Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process.