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EN ISO 11737-2:2009 Standard

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  Keywords:

#sterility #process #sterilization #maintenance #validation

This standard is superseded by: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

    Corrigendum to EN ISO 11737-1:2006.

      Publication

    Friday 17th of November 2017

      Related Standards

    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)

    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 11607-2:2020

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

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

    EN ISO 11607-1:2020

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

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

    EN ISO 11737-2:2020

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

    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

    EN ISO 13408-7:2015

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

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

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