Standards Development

Scope

This European Standard specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices.This European Standard specifies minimum requirements•for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;•for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;•for the test equipment and test procedures used to verify the sterilizer performance specified by this European Standard.This European Standard does not specify requirements for equipment intended to process liquids, biological waste or human tissues.This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.This European Standard does not specify requirements and tests for decontamination systems for use in rooms, enclosures or environmental spaces.NOTE 1Attention is drawn to the standards for quality management, e.g. EN ISO 13485.NOTE 2Environmental aspects of this standard are addressed in Annex H.