3.4.1 eto灭菌机温度设定范围
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
当电离室工作压力大于5kPa时，还应进行正压泄漏试验，该试验应在真空阶段之前进行。用惰性气体（如空气）加压至预设工作压力的10%以内，应监测灭菌室内的压力至少5分钟，期间压力下降不得超过0.3kPa/min。
3.4.4 eto灭菌机真空度
在空载条件下，EO室应在约6分钟内从大气压力达到-15 kPa；约 30 分钟内达到-50 kPa；约 40 分钟内达到-75 kPa。
3.4.5 eto灭菌机的加湿效果
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
表面上的所有文字、图形、符号等应印刷清晰，标记清晰、准确、耐久。
3.4.8.3
紧固件应安装牢固，各控制开关和调节旋钮（按钮）操作灵活可靠，无阻碍现象。
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