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EN ISO 11135:2014 Standard

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  Keywords:

#amendment #development #devices #medical #process

This standard can be totally or partially supervised by:
  •   EN ISO 11135:2014/A1:2019
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Friday 16th of July 2021

      Description:

    Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

      Purpose

    Amendment for EN ISO 11135:2014

      Publication

    Friday 16th of July 2021

      Related Standards

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    Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical dev...

    EN ISO 17665-1:2006

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    EN ISO 18777:2009

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    Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

    EN ISO 18778:2009

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    Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

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