Residual Ethylene Oxide (ETO) and Ethylene Chlorohydrin (ECH) Analysis

Ethylene oxide (ETO) is widely used as a sterilizing agent for medical devices, thanks to its comprehensive material compatibility and effectiveness. However, this compound may leave residue on devices being processed. Residues can be harmful to the end user or patient. In this regard, all devices used must meet the limits specified in the AAMI 10993-7 standard.

In the ANSI/AAMI/ISO 10993-7 standard published jointly by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Devices (AAMI), allowable for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in medical devices sterilized with ethylene oxide limits, procedures for measurements and conformity determination methods for the release of devices are described. The full name of this standard is: ANSI/AAMI/ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues. Devices sterilized with ethylene oxide without patient contact, such as in vitro diagnostic devices, are not covered by this standard.

Companies that use ethylene oxide as a sterilant are required to demonstrate that ethylene oxide and its common decomposers, ethylene chlorohydrin, have been removed from the product and packaging.

The residual ethylene oxide analysis technique is used to identify and characterize ethylene oxide, ethylene chlorohydrin, and ethylene glycol by gas chromatography. This technique helps manufacturers demonstrate the safety of products sterilized with ethylene oxide by determining compliance with accepted residue limits.

A standard based on residual ethylene oxide (ETO) and ethylene chlorohydrin (ECH) analysis is the following standard developed by the International Standards Organization (ISO): ISO 11135 Sterilization of healthcare products - Ethylene oxide - Development, validation and verification of a sterilization process for medical devices. requirements for routine control. This standard describes the requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings.

Our organization also provides residual ethylene oxide (ETO) and ethylene chlorohydrin (ECH) analysis services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.