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