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Status : Active
Standard Type : Main
Document No : ISO 14937:2009
Document Year : 2009
Pages : 37
Edition : 2
Section Volume : Sterilization of health care products (ISO/TC 198.)
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.