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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This standard is superseded by: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

    Medical devices Directive (93/42/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    This standard has been withdrawn on 2021-09-30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 12870:2009

    Medical devices Directive (93/42/EEC)

    Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

    EN ISO 9713:2009

    Medical devices Directive (93/42/EEC)

    Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

    EN ISO 7886-3:2009

    Medical devices Directive (93/42/EEC)

    Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

    EN ISO 7886-4:2009

    Medical devices Directive (93/42/EEC)

    Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

    EN ISO 8185:2009

    Medical devices Directive (93/42/EEC)

    Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

    EN ISO 8835-2:2009

    Medical devices Directive (93/42/EEC)

    Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

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