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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 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

Wednesday 5th of July 2023

  Amendment

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

  Related Standards

EN ISO 25424:2019

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 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...

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 11137-1:2015/A2:2019

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...

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