3.4.1 eto sterilizer machine Temperature Setting Range
The temperature setting range for the eto sterilizer is: 30 to 70°C, with a control error of ?2°C.
3.4.2 Temperature Uniformity of the ethylene oxide machine
The temperature uniformity of the eto sterilizer must meet the following requirements:
When the volume of the sterilization chamber is ?5m³, at least 10 measurement points must be placed.
When the volume is >5m³, for every additional 1m³, one more measurement point should be added.
When the volume is ?10m³, at least 20 measurement points must be set inside the chamber, with the test temperature ?40°C, and the temperature difference between each measurement point must not exceed ±3°C.
3.4.3 Sterilization Chamber Leakage Rate
3.4.3.1
Testing should be conducted before the injection phase of the sterilizing agent and the humidification phase (if using an inserted temperature and pressure display device). The pressure should be preset by the manufacturer, and the test pressure should be less than -20 kPa and at least 20 kPa lower than the preset sterilization pressure.
3.4.3.2
If the pressure during any stage of the sterilization cycle is below atmospheric pressure, after reaching the preset pressure, all valves connected to the sterilization chamber should be closed, and the vacuum pump should stop working. The pressure in the sterilization chamber should be monitored for at least 5 minutes, during which the pressure rise must not exceed 0.3 kPa/min.
3.4.3.3
When the working pressure of the eo chamber is greater than 5 kPa, a positive pressure leakage test should also be conducted, which should be performed before the vacuum stage. By pressurizing with inert gas (such as air) to within 10% of the preset working pressure, the pressure in the sterilization chamber should be monitored for at least 5 minutes, during which the pressure drop must not exceed 0.3 kPa/min.
3.4.4 eto sterilizer machine Vacuum Rate
Under no-load conditions, the eo chamber should reach -15 kPa from atmospheric pressure in ?6 minutes; reach -50 kPa in ?30 minutes; and reach -75 kPa in ?40 minutes.
3.4.5 Humidification Effect of the eto sterilizer machine
Under no-load conditions, when the relative humidity is ?40% RH, the eo sterilization machine should have the capability to increase the relative humidity to at least 75% or higher through the humidification system.
3.4.6 Pressure Setting Range of the Sterilization Chamber
The pressure setting range for the sterilization chamber is -0.08 MPa to +0.08 MPa.
3.4.7 Maximum Noise Level of the eto sterilizer machine
The maximum noise level (A-weighted) produced by the eto sterilization chamber should be ?65 dB.
3.4.8 Appearance and Structure of the ethylene oxide sterilizer
3.4.8.1
The shape should be upright, with a smooth and clean surface, uniform color, and free of burrs, sharp edges, and cracks. There should be no obvious scratches or defects such as bumps.
3.4.8.2
All text, graphics, symbols, etc., on the surface should be printed clearly, with markings that are clear, accurate, and durable.
3.4.8.3
Fasteners should be installed securely, and all control switches and adjustment knobs (buttons) should operate flexibly and reliably, without any obstruction.
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