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EN ISO 25424:2019 Standard

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  Keywords:

#requirements #devices #medical #process #sterilization

This standard can be totally or partially supervised by:
  •   EN ISO 25424:2019/A1:2022
  •   This standard is no longer addressed in the last official Journal publication of the "2026-01-28 ". This standard is addressed for the last time in the official journal publication of the "2023-07-05"

      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 - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

      Purpose

    Amendment to EN ISO 25424:2019

      Publication

    Tuesday 20th of July 2021

      Cessation

    This standard has been withdrawn on 2023-07-05

      Related Standards

    EN ISO 13485:2016

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

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    EN ISO 18113-2:2024

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

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents ...

    EN ISO 13485:2016/A11:2021

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

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    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 13408-6:2021

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

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

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