International Standard
ISO 14937:2009
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
Reference number
ISO 14937:2009
Edition 2
2009-10
© ISO 2024
International Standard
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Published (Edition 2, 2009)
This standard was last reviewed and confirmed in 2020. Therefore this version remains current.

ISO 14937:2009

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CHF 173
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Abstract

ISO 14937:2009 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.

It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.

ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.

General information

  • Status
     : Published
    Publication date
     : 2009-10
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 2
    Number of pages
     : 37
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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