EO, ECH & EG Residual Testing for Medical Devices
Compliant with ISO 13485 & Sterilization Standards
Ethylene Oxide (EO) sterilization is widely used for medical devices, but it requires strict control of residuals to ensure patient safety. Our laboratory provides highly accurate and fully compliant testing services for Ethylene Oxide (EO), Ethylene Chlorohydrin (ECH), and Ethylene Glycol (EG) residuals in accordance with applicable regulatory standards.
Why Choose Us
Deep expertise in EO sterilization and residual chemistry
Reliable, reproducible, and defensible analytical results
Flexible project support—from development to routine testing
Fast turnaround without compromising quality
Dedicated technical support and regulatory guidance
Why Residual Testing Matters
After EO sterilization, trace levels of EO and its byproducts (ECH and EG) may remain in medical devices. These substances can pose toxicological risks if not reduced below acceptable limits.
Residual testing is critical to:
Ensure patient safety and biocompatibility
Demonstrate compliance with ISO 10993-7
Support regulatory submissions (FDA, MDR, etc.)
Validate sterilization processes and aeration cycles
Our Capabilities
We offer comprehensive analytical services tailored to your device and regulatory requirements:
Residual Analysis
Quantitative determination of:
Ethylene Oxide (EO)
Ethylene Chlorohydrin (ECH)
Ethylene Glycol (EG)
Sensitive detection using validated analytical methods (e.g., GC)
Method Development & Validation
Custom method development for complex materials or geometries
Full validation in line with ISO 10993-7 and ISO 17025 principles
Support for worst-case product testing
Routine & Batch Testing
Fast turnaround for production release testing
Scalable solutions for ongoing quality control
Robust data integrity and traceability
Standards & Compliance
Our testing services are performed within a quality system aligned with:
ISO 13485 – Medical device quality management
ISO 10993-7 – EO sterilization residual limits
ISO/IEC 17025 (where applicable) – Laboratory competence
Regulatory expectations from FDA, EU MDR, and global authorities
We ensure your data meets the strict documentation and validation requirements necessary for regulatory approval.
Industries We Support
Medical device manufacturers
Pharmaceutical packaging providers
Contract sterilization providers
OEM suppliers