作者名稱：博康技術團隊

Start cycle phase(Select parameters/sterilization recipe) Serial number Potentially risky content Risk assessment under existing process conditions Risk assessment of the

9.1 During ETO Sterilization, operators are not allowed to leave the operating area and must continuously observe the ETO Sterilization process. If any abnormal phenomena occur, the machine must be immediately shut down, and the power supply should be cut off for inspection.

For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of

Appearance Inspection: Check for any damage on the surfaces of the main machine, control rack, and electrical control cabinet.
Power Supply Check: Ensure the power supply meets the requirements and check the rotation direction of the water pump and vacuum pump.
Turn on the power and observe whether the instrument display values are normal; otherwise, cut off the power, inspect and repair before restarting.
Pipeline Inspection: Check for leaks in the water supply, vacuum, and medication delivery pipelines, and ensure all valves are in standby mode; adjust if necessary.

2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.
2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.
2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.

Within a certain range of gas concentration, the higher the concentration, the better theEO Gas Sterilization effect; beyond 1000 mg/L, the improvement in sterilization effect is not significant.

eto sterilization technologies vs others: Advantages and Disadvantages Sterilization is a critical process in infection control, ensuring that medical instruments

The temperature setting range of the ETO Sterilization Chamber should be between 30-60°C. It is recommended to perform temperature distribution testing of the sterilizer’s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.

The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the following content: