Product Introduction:

An EO sterilizer is a device that uses ethylene oxide gas to sterilize medical items that are sensitive to heat or moisture. Its core value lies in low-temperature penetration: it can effectively sterilize complex instruments (such as long-lumen endoscopes, plastic products, and electronic components) without damaging them.

Definition and Standard Classification

According to China’s pharmaceutical industry standard YY 0503-2023, an EO sterilizer is an “automatically controlled sterilizer that uses ethylene oxide gas as the sterilizing agent,” applicable to industrial production and medical institutions. The standard does not apply to devices that directly inject EO into packaging .

In terms of classification management, this type of product is a Class II medical device in China, usually consisting of a sterilization chamber, heating system, vacuum system, dosing and vaporization device, and residual gas treatment system 

Key Data and Performance Indicators

· Sterility Assurance Level (SAL): Industry standards require that medical devices entering the human body achieve an SAL of 10⁻⁶, meaning the probability of a single microorganism surviving is one in one million .

· Sterilization cycle: Depending on the equipment and load, typical cycles can be completed within several hours. For example, some desktop models can complete sterilization and aeration in approximately 3.5 hours .

· EO usage: Traditional large chamber sterilizers consume a large amount of gas; some modern small devices use “micro-dose” technology, reducing the amount of EO per cycle to about 17.6 grams, significantly reducing operating exposure and emission risks