Ethylene Oxide Residuals Testing –
Ensuring Sterilization Safety for
Medical Devices
Ethylene oxide (EO) sterilization is widely used for heat-sensitive medical devices, but residual EO or its by-products—such as ethylene chlorohydrin (ECH) and ethylene glycol (EG)—can pose serious health risks if not properly removed. EO Residuals Testing ensures that sterilized devices meet permissible limits defined by ISO 10993-7 and other international standards. At SIMA LABS, we conduct precise EO residual analysis using Gas Chromatography (GC) to detect and quantify EO, ECH, and EG levels. Our testing verifies that devices are both sterile and safe for clinical use, ensuring patient safety while maintaining product quality.
Why Choose SIMA LABS for Ethylene Oxide Residuals Testing?
- Global Standards Compliance – ISO 10993-7, FDA, and EU medical device safety requirements.
- Advanced Detection Technology – High-sensitivity GC systems for accurate EO, ECH, and EG measurement.
- Wide Product Coverage – Surgical instruments, catheters, implants, wound dressings, and disposable devices.
- Regulatory Support – Detailed compliance reports for CE Marking, FDA, and BIS submissions.
- Controlled Testing Environment – Validated procedures to prevent contamination or false positives.
- Proven Expertise – Years of experience in EO sterilization safety validation.
35+ Years of SIMA LABS – Ethylene Oxide Residuals Testing You Can Trust
SIMA LABS is NABL accredited and approved under BIS for conducting Ethylene Oxide (EO) Residuals Testing in compliance with ISO 10993-7, FDA, and EU medical device safety requirements. Our testing ensures that sterilized devices meet permissible EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) residual limits to safeguard patient health and regulatory compliance.
We provide high-precision EO residuals analysis to ensure that medical devices sterilized with ethylene oxide are safe for clinical use.
Scope of Testing:
Parameters Measured:
Ethylene Oxide (EO)
Ethylene Chlorohydrin (ECH)
Ethylene Glycol (EG)
Products Covered:
Catheters, tubing, and surgical sets
Implants and prosthetics
Wound dressings and bandages
Disposable medical devices
Heat-sensitive instruments
Technology Used:
Gas Chromatography (GC) with Flame Ionization Detector (FID)
Headspace GC analysis
Regulatory Compliance:
ISO 10993-7: Biological evaluation of medical devices – EO sterilization residuals
US FDA and EU MDR requirements
BIS medical device standards
With state-of-the-art GC instrumentation, validated test methods, and expert analysts, SIMA LABS ensures your EO-sterilized medical devices are safe, compliant, and ready for market release worldwide.
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Our Expertise
At Sima Labs, we specialize in advanced analytical testing, regulatory compliance, and quality assurance across the food, pharmaceutical, and environmental sectors—delivering reliable results with international standards and technical excellence.
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SIMA LABS offers environmental testing for pollutants, gases, and air quality monitoring.
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