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EN ISO 11137-1:2015/A2:2019 Standard

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  Keywords:

#amendment #iso #sterilization #health #care

This standard is superseded by:
  •   EN ISO 11137-1:2026
  •   Directive

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

      Last Official Journal reference

    Monday 9th of November 2026

      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

      Cessation

    This standard will be withdrawn on 2028-05-10

      Amendment

    This standard is an amendment for "EN ISO 11137-1:2015"

      Related Standards

    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

    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...

    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 11737-2:2020

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

    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

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