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EN ISO 11137-1:2015 Standard

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  Keywords:

#devices #medical #process #sterilization #control

This standard can be totally or partially supervised by:
  •   EN ISO 11137-1:2015/A2:2019
  •   Directive

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

      Last Official Journal reference

    Wednesday 5th of July 2023

      Description:

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

      Purpose

    Amendment for EN ISO 11137-1:2015

      Publication

    Tuesday 20th of July 2021

      Related Standards

    EN ISO 11737-1:2018/A1:2021

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

    EN ISO 25424:2019/A1:2022

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

    EN ISO 11135:2014

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

    EN ISO 11135:2014/A1:2019

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

    EN ISO 11137-1:2015/A2:2019

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

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

    EN ISO 11737-1:2018

    In vitro diagnostic medical devices Regulation ((EU) 2017/746)

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

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