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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
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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

PUBLISH DATE 2009
ISO 14937:2009

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.

SDO ISO: International Organization for Standardization
Document Number ISO 14937
Publication Date Oct. 15, 2009
Language en - English
Page Count 46
Revision Level
Supercedes
Committee ISO/TC 198
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