GSO ISO 11737-2:2015

ISO 11737-2:2009

Gulf Standard Current Edition · Approved on 03 September 2015

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

GSO ISO 11737-2:2015 Files

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GSO ISO 11737-2:2015 Scope

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 17665-1. c) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 14161 [8].