Need help?

EN ISO 14937:2009 Standard

wave
Save  

  Keywords:

#process #medical #devices #sterilization #control

  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 - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

  Purpose

This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 14937:2000"

Anyway is still possible use the "EN ISO 14937:2000" until April 30th, 2010

  Related Standards

EN ISO 25424:2019

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

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN ISO 18113-3:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instrumen...

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...

EN 12322:1999

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

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN 12322:1999/A1:2001

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

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN ISO 13408-1:2015

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

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0