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EN ISO 25424:2019 Standard

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  Keywords:

#requirements #devices #medical #process #sterilization

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th 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 10993-7:2008/AC:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-1:2009/AC:2010

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 11135-1:2007

Active implantable medical devices Directive (90/385/EEC)

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

EN ISO 10993-18:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

EN ISO 10993-17:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 10993-16:2010

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-...

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