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 ETO 殺菌期間，操作員唔可以離開操作區域，並且必須持續觀察 ETO 殺菌過程。如果出現任何異常現象，必須立即停機，並切斷電源檢查。

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.