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EN ISO 10993-7:2008 Standard

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  Keywords:

#amendment #devices #residuals #sterilization #oxide

This standard can be totally or partially supervised by:
  •   EN ISO 10993-7:2008/AC:2009
  •   Directive

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

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

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

      Purpose

    Amendment to EN ISO 10993-7:2008

      Publication

    Friday 17th of November 2017

      Related Standards

    EN ISO 13408-5:2011

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

    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

    EN ISO 13408-7:2015

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

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

    EN ISO 10993-18:2020

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

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

    EN ISO 10993-16:2017

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

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-...

    EN ISO 11138-2:2009

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

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

    EN ISO 11138-3:2009

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

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

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