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MS ISO 11737-2:2011
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, IDT)
This Malaysian Standard 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.
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;
c) culturing of biological indicators or inoculated products.
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04/06/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
07.100.10 11.080.01
30.00