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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 ISO 13485:2016/AC:2018

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

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

EN ISO 17511:2003

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

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assign...

EN 14254:2004

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

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN 14820:2004

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

Single-use containers for human venous blood specimen collection

EN ISO 14937:2009

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

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

EN ISO 14971:2012

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

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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