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EN ISO 25424:2019/A1:2022 Standard

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  Keywords:

#requirements #devices #medical #process #sterilization

  Directive

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

  Last Official Journal reference

Wednesday 28th of January 2026

  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

Wednesday 5th of July 2023

  Amendment

This standard is an amendment for "EN ISO 25424:2019"

  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

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

EN ISO 13485:2016/AC:2018

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

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

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 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 18113-5:2024

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

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