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EN ISO 25424:2019 Standard

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  Keywords:

#requirements #devices #medical #process #sterilization

  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 556-2:2015

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 13408-6:2011

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN 13975:2003

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

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

EN 13641:2002

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

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

EN 13612:2002/AC:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

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