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EN ISO 11137-1:2015 Standard

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  Keywords:

#amendment #iso #sterilization #health #care

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

    In vitro diagnostic medical devices Directive (98/79/EC)

      Last Official Journal reference

    Thursday 15th of April 2021

      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

    Friday 17th of November 2017

      Related Standards

    EN 556-1:2001

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN 556-1:2001/AC:2006

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN 556-2:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN ISO 11137-2:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    EN ISO 11737-2:2009

    In vitro diagnostic medical devices Directive (98/79/EC)

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

    EN ISO 13408-1:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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