ISO 11737-2:2009 医疗器械的灭菌 微生物学方法 第2部分：定义、确认和保持灭菌过程的无菌试验

标准编号：ISO 11737-2:2009

中文名称：医疗器械的灭菌 微生物学方法 第2部分：定义、确认和保持灭菌过程的无菌试验

英文名称：Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

发布日期：2009-11

标准范围

ISO 11737-2:2009规定了医疗器械无菌测试的一般标准，这些医疗器械已暴露在灭菌剂比常规灭菌处理中预期使用的灭菌剂减少的处理中。这些测试旨在定义、验证或维护灭菌过程时进行。

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.

标准预览图