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EN ISO 11737-2:2009 Standard

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  Keywords:

#test #tests #product #products #used

This standard is superseded by:
  •   EN ISO 11737-2:2020
  •   Directive

    In vitro diagnostic medical devices Directive (98/79/EC)

      Last Official Journal reference

    Thursday 15th of April 2021

      Description:

    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)

      Purpose

    ISO 11737-2 specifies the general criteria for tests of sterility on medical devices. These tests are intended to be performed when defining, validating or maintaining a sterilization process. A sterile medical device is free from viable microorganisms. Medical devices can, before sterilization, have microorganisms on them. Which means such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants. The standards for quality management systems recognise that, for certain processes used in manufacturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process is monitored routinely and the equipment is maintained. ISO 11737-2 gives guidance on tests of sterility performed in the validation and maintenance of a sterilization process. It is not meant to be used for sterility testing for routine release of a product that has been subjected to a sterilization process, performing a test for sterility test of sterility or test for sterility for demonstration of product shelf life, stability or package integrity or culturing of biological indicators or inoculated products. The international standard has been approved in Europe as EN ISO 11737-2:2020 without any changes and it supersedes EN ISO 11737-2:2009.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN 13641:2002

    In vitro diagnostic medical devices Directive (98/79/EC)

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents

    EN 14820:2004

    In vitro diagnostic medical devices Directive (98/79/EC)

    Single-use containers for human venous blood specimen collection

    EN ISO 13408-2:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

    EN ISO 13408-3:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    EN ISO 13408-4:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 13408-5:2011

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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