scope:

This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, using 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 document 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 document.

This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues unless part of a medical device.

This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.

NOTE Attention is drawn to the standards for quality management, e.g. EN ISO 13485.

This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.