BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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.
BS EN ISO 11737-2:2009 Referenced Document
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
BS EN ISO 11737-2:2009 history
1970BS EN ISO 11737-2:2020 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
2010BS EN ISO 11737-2:2010 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
2010BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process was changed to ISO 4802-2:2016 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification.