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EN ISO 14937:2009 Standard

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  Keywords:

#process #medical #devices #sterilization #control

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th 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 26782:2009/AC:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

EN ISO 11197:2009

Medical devices Directive (93/42/EEC)

Medical supply units (ISO 11197:2004)

EN ISO 13485:2016

Medical devices Directive (93/42/EEC)

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

EN ISO 13408-7:2015

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 13408-6:2011

Medical devices Directive (93/42/EEC)

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

EN ISO 13408-5:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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