2024 年 11 月

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

外觀檢查：檢查主機、控制架、電氣控制櫃表面有無損傷。
電源檢查：確保電源符合要求，檢查水泵、真空幫浦的旋轉方向。
打開電源，觀察儀表顯示值是否正常；否則，應切斷電源，檢查修理後再重新啟動。
管路檢查：檢查供水、真空、輸藥管是否有洩漏，確保所有閥門處於備用狀態；必要時進行調整。

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:

過程挑戰設備（PCD）是用於評估選定過程參數的殺戮率的微生物挑戰系統。它通常是包含生物學指標的設備或測試套件（例如，具有已知孢子計數的芽孢桿菌孢子）。 PCD對滅菌過程的電阻應大於或等於產品最難殺傷區域的天然微生物載荷的電阻。 PCD的數量應滿足GB18279.1-2015中附錄C的表C.3中概述的要求。 PCD分為內部PCD（IPCD）和外部PCD（EPCD）。

Industry Eto Sterilizer Installation Verification The installation of Industry Eto Sterilizer and all associated services should comply with the requirements

The humidification water used in the ETO Sterilization Equipment should be free from contaminants, should not weaken the ETO sterilization process, and should not damage the sterilizer, sterilized products, or the load. Humidification should be done by injecting steam, not by directly injecting atomized water.