Need help?

EN ISO 11737-2:2009 Standard

wave
Save  

  Keywords:

#sterility #process #sterilization #maintenance #validation

This standard is superseded by: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

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

      Last Official Journal reference

    Monday 19th of July 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 11137-2:2015

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

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    EN ISO 14937:2009

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

    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

    EN ISO 25424:2019

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

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

    EN ISO 11135:2014

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

    Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a steri...

    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...

      Stay up to date

      ACCESS

    Search for a standard
    GO

    Register

    Already a member?
    Login

      OTHER APPLICATIONS

    If you are interested in DO160 tests, you can give a try to our other free of charge software:
    CE-Marking assistant, Version: 1.3.0