3.4.1 eto sterilizer مشين جي درجه حرارت سيٽنگ رينج
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
بغير لوڊ جي حالتن ۾، جڏهن نسبتي رطوبت 40٪ RH آهي، اي او اسٽريلائيزيشن مشين کي اها صلاحيت هجڻ گهرجي ته رطوبت نمي کي گهٽ ۾ گهٽ 75٪ يا وڌيڪ تائين وڌائي سگهي.

3.4.6 اسٽريلائيزيشن چيمبر جي پريشر سيٽنگ رينج
اسٽريلائيزيشن چيمبر لاءِ پريشر سيٽنگ جي حد -0.08 MPa کان +0.08 MPa آهي.

3.4.7 ايٽو اسٽريلائيزر مشين جي وڌ ۾ وڌ شور جي سطح
وڌ ۾ وڌ شور جي سطح (A-weighted) eto sterilization chamber پاران پيدا ڪيل 65 dB هجڻ گهرجي.

3.4.8 ethylene oxide sterilizer جي ظاهر ۽ ساخت
3.4.8.1
شڪل سڌي ھئڻ گھرجي، ھڪ سھڻي ۽ صاف مٿاڇري سان، يونيفارم رنگ ھجي، ۽ ٻرندڙ، تيز ڪنارن ۽ ٽڪرن کان خالي ھجي. ڪو به واضح خرچي يا خرابي نه هجڻ گهرجي جهڙوڪ bumps.

3.4.8.2
مٿاڇري تي سڀئي متن، گرافڪس، علامتون، وغيره واضح طور تي ڇپجڻ گهرجن، نشانن سان جيڪي صاف، صحيح ۽ پائيدار هجن.

3.4.8.3
فاسٽنرز کي محفوظ طور تي نصب ڪيو وڃي، ۽ سڀني ڪنٽرول سوئچز ۽ ترتيب ڏيڻ واري نوب (بٽن) کي لچڪدار ۽ معتبر طريقي سان هلائڻ گهرجي، بغير ڪنهن رڪاوٽ جي.

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