ISO 10993.7 Gas Chromatography for Ethylene Oxide

Detection target

Determination of ethylene oxide content

Introduction

Ethylene oxide (EO), as a highly effective low-temperature sterilizing agent, is widely used in the sterilization of medical devices (especially those made of heat-sensitive plastics, rubber, and polymer materials, such as face masks). However, residual ethylene oxide and its reaction products (such as 2-chloroethanol) have potential carcinogenic, mutagenic, and irritant effects, which may pose risks to the health of patients and healthcare workers. Therefore, the residual ethylene oxide levels in medical devices must be strictly tested and controlled before they are placed on the market to ensure that the biological safety of the products meets relevant international standards (such as ISO 10993-7) and various regulatory requirements. Gas chromatography is typically used to quantitatively assess the residual ethylene oxide in products after a specified aeration period following sterilization. This analysis is a critical step in the quality control and registration of medical devices.

Overview

This solution conforms to the ISO 10993.7 Medical devices. Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals. The instrument tests the residual amount of ethylene oxide in medical devices after ethylene oxide sterilization. The standard requires the detection of extremely low levels of residue (EO limits are typically measured in μg/g), therefore this instrument offers the advantages of high sensitivity and a low detection limit.

Apparatus

HKL-10993 Gas Chromatograph for Ethylene Oxide

Configuration