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ONORM EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
This document lays down the general criteria for testing the sterility of medical devices undergoing sterilising treatment, which has been reduced compared to that expected to be used in routine sterilization procedures. These tests are provided for when a sterilisation process is defined, validated or maintained. This document shall not apply to: (a) the sterility test for the routine release of a product that has undergone a sterilisation procedure; (b) carrying out a sterility test; (c) checking sterility or testing for sterility to demonstrate the shelf life and stability of the product and/or the integrity of the packaging; and (d) the cultivation of biological indicators or infused products.
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Austrian Standards Institute [on]
