оксид этилена (ЭО) Sterilization Glossary
Understanding the technical terminology is essential for maintaining compliance with FDA and ISO 11135 стандарты. Below is an alphabetical guide to terms frequently used in оксид этилена (ЭО) стерилизация discussions among medical device manufacturers.
The process of removing газ ЭО from a sterilized product by exposing it to air to reduce residual EO levels.
The number and type of microorganisms present on a product prior to the EO sterilization process.
The sealed vacuum container where the sterilization process takes place under controlled parameters.
A colorless gas used as a potent sterilant due to its ability to penetrate packaging and reach complex device areas.
The movement of газ ЭО molecules from areas of high concentration to areas of low concentration within the load.
The measured ability of the sterilization process to effectively kill specific microorganisms.
Preparing a product by exposing it to controlled humidity and temperature prior to EO gas injection.
The documented process of verifying that the sterilization cycle consistently achieves the desired sterility level.
Critical Technical Metrics: D-Value
In Ethylene Oxide sterilization technology, тот D-value is one of the most vital metrics for quality control. It represents the specific time required to achieve a one-log (90%) reduction in the number of viable microorganisms at a set temperature and gas concentration.
БОКОН: Your Expert in EO Sterilization Compliance
БОКОН Стерилизаторы ETO серии BCS are designed to meet all FDA sterilization и ИСО 11135 requirements. Our equipment provides precise control over gas concentration, exposure time, и aeration, ensuring your products achieve the highest standards of safety and low residual EO levels.
