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EVS-EN ISO 11737-2:2010

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

General information
Withdrawn from 02.06.2020
Base Documents
ISO 11737-2:2009; EN ISO 11737-2:2009
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.06.2020
Main
04.03.2010
Main
Main
EVS-EN ISO 11737-2:2000
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);
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