Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
医疗器械的灭菌 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中进行的无菌检测(ISO 11737-2:2009)
发布日期:
2009-11-15
废止日期:
2020-05-13
ISO 11737-2:2009规定了相对于预期在常规消毒处理中使用的灭菌剂已经暴露于治疗的医疗器械上的无菌测试的一般标准。这些测试旨在在定义,验证或维持灭菌过程时执行
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.