ISO-14937 › 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 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.
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Document Number
ISO 14937:2009
Revision Level
2ND EDITION
Status
Current
Publication Date
Oct. 15, 2009
Committee Number
ISO/TC 198