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This standard is superseded by: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
  •   This standard is no longer addressed in the last official Journal publication of the "2021-04-14 ". This standard is addressed for the last time in the official journal publication of the "2020-03-25"

      Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      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

      Cessation

    This standard has been withdrawn on 2021-04-14

      Related Standards

    EN ISO 25539-2:2009

    Medical devices Directive (93/42/EEC)

    Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

    EN ISO 10993-1:2009/AC:2010

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

    EN ISO 11140-1:2009

    Medical devices Directive (93/42/EEC)

    Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

    EN ISO 11138-2:2009

    Medical devices Directive (93/42/EEC)

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

    EN ISO 11137-2:2015

    Medical devices Directive (93/42/EEC)

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

    EN ISO 11137-1:2015

    Medical devices Directive (93/42/EEC)

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

      Stay up to date

    CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

    CELAB performs voluntary inspection activities on technical construction files to check their contents.

    CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

    CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 11737-2:2009 STANDARD

      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