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EN ISO 25424:2019 Standard

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  Keywords:

#amendment #iso #sterilization #health #care

  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 - 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 25th of March 2020

  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 11137-1:2015

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

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

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...

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