Need help?

EN ISO 25424:2019/A1:2022 Standard

wave
Save  

  Keywords:

#requirements #devices #medical #process #sterilization

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 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 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

EN ISO 17665:2024

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterili...

EN ISO 11737-1:2018

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 11737-1:2018/A1:2021

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 11737-2:2020

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 13408-6:2021

Medical devices Regulation ((EU) 2017/745)

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

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0