1.1 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.1.2 This part of ISO 11737 is not applicable to:a) sterility testing for routine release of product that has been subjected to a sterilization process;b) performing a test for sterility (see 3.12);NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO
DS/EN ISO 11737-2-2010由丹麦标准化协会 DK-DS 发布于 2010-01-15,并于 2010-01-15 实施。
DS/EN ISO 11737-2-2010在国际标准分类中归属于: 11.080.01 消毒和灭菌综合。
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