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EN ISO 13408-2:2011 Standard

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  Keywords:

#part #filtration #applicable #filter #aseptic

This standard is superseded by:
  •   EN ISO 13408-2:2018
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

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

      Purpose

    This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-09-30

      Reference

    This standard supersedes the "EN 13824:2004"

    Anyway is still possible use the "EN 13824:2004" until December 31st, 2011

      Related Standards

    EN ISO 13408-6:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

    EN 556-2:2015

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN ISO 10993-9:2009

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

    EN ISO 10993-7:2008/AC:2009

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    EN ISO 10993-7:2008

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

    EN ISO 10993-6:2009

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

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