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EN ISO 14937:2009 Standard

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  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 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 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 14136:2004

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

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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 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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