60.60 Standard published Oct 15, 2009
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
Published
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.
Legislation related to this standard
WITHDRAWN
EN ISO 14937:2000/AC:2003
WITHDRAWN
EN ISO 14937:2000/AC:2005
WITHDRAWN
EN ISO 14937:2000
PUBLISHED
EN ISO 14937:2009
60.60
Standard published
Oct 15, 2009
