DIN EN ISO 11737-2-2010 医疗器械灭菌.微生物学方法.第2部分:灭菌过程的定义、有效性和维护中进行的无菌试验(ISO 11737-2-2009); 德文版本 EN ISO 117

标准号：DIN EN ISO 11737-2-2010
中文标准名称：医疗器械灭菌.微生物学方法.第2部分:灭菌过程的定义、有效性和维护中进行的无菌试验(ISO 11737-2-2009); 德文版本 EN ISO 11737-2-2009
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 (ISO 11737-2:2009); German version EN ISO 11737-2:2009
标准类型：C46
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：C46
国际标准分类号：07.100.10;11.080.01
引用标准：ISO 10012;ISO 11737-1-2006;ISO 13485-2003;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 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.