EO & ECH Residual Testing (ISO 10993-7)
Verify the safety of your gas-sterilized devices. Our ISO 17025 accredited laboratory provides precise analysis of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals to ensure full compliance with global safety limits.
Ethylene oxide (EO) is a highly effective, colorless gas used to sterilize approximately 50% of all medical devices globally. However, because EO is also a known carcinogen and mutagen, it is vital to ensure that any remaining gas or its by-products—specifically Ethylene Chlorohydrin (ECH)—do not exceed permitted maximum levels. At EBI, we provide specialized gas chromatography analysis to quantify these residuals, ensuring your product is safe for patient contact.
Why Residual Testing is Mandatory
Testing according to ISO 10993-7 is a critical component of your biological safety evaluation. It addresses several key regulatory and safety needs:
- Patient & User Safety: High levels of residuals can cause irritation, tissue damage, or systemic toxicity. We ensure your device is within the „Permissible Exposure” limits.
- Regulatory Compliance: Adherence to ISO 10993-7 is required for CE Marking (MDR), FDA 510(k) submissions, and Japanese MHLW (JIS T 0993-7) approvals.
- Risk Mitigation: Identifying residual levels helps you optimize your aeration (degassing) times, streamlining your production cycle while maintaining safety.
- Quality Assurance: As an ISO 17025 accredited laboratory, EBI provides the high-fidelity data required to prove your sterilization process is under control.
Our Testing Methodology
EBI follows the rigorous framework provided by ISO 10993-7 to evaluate the biological safety of sterilized devices.
- Extraction: We use validated extraction methods (simulated use, exaggerated or exhaustive extraction) using polar vehicles to remove residuals from the device.
- Analysis: Using Gas Chromatography (GC), we identify and quantify the concentration of:
- EO (Ethylene Oxide): The primary sterilant.
- ECH (Ethylene Chlorohydrin): A toxic by-product formed when EO reacts with chloride ions (common in PVC or materials containing chlorine).
- Reporting: We calculate the total dose delivered to the patient and compare it against the limit categories defined by the standard (Limited, Prolonged, or Permanent contact).
Sample Requirements & Logistics
Due to the volatile nature of EO gas, strict transportation protocols must be followed to prevent gas dissipation before testing.
- Sample Requirements:
- At least 3 non-sterile test items (for baseline/control).
- At least 3 test items taken directly from the EO sterilization process.
- Transportation: Samples must be transported on dry ice to the testing unit to „freeze” the residual levels in place.
- Turnaround Time: Dependent on the device type and required aeration time, but typically optimized to support your manufacturing schedule.
Standards & Compliance
Our laboratory conducts residual testing in accordance with:
- ISO 10993-7: Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals.
- JIS T 0993-7: Japanese Industrial Standards for EO residuals.
- ISO 17025: General requirements for the competence of testing and calibration laboratories.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Frequently Asked Questions about EO Testing
Which contact category does my device fall into?
ISO 10993-7 categorizes devices based on the duration of patient contact: Limited (<24h), Prolonged (24h to 30 days), and Permanent (>30 days). Permissible residual limits become significantly stricter as the contact duration increases.
What is Ethylene Chlorohydrin (ECH) and why test for it?
ECH is a toxic chemical formed during EO sterilization if the device contains chlorine (like PVC). Because ECH is more persistent and often more toxic than EO itself, ISO 10993-7 sets specific limits for ECH that must be verified alongside EO levels.
Can I use data from a similar device?
While characterization can provide clues, regulatory bodies almost always require device-specific residual testing because the geometry, material density, and packaging of your specific product uniquely affect gas retention and aeration.
Which contact category does my device fall into?
ISO 10993-7 categorizes devices based on the duration of patient contact: Limited (<24h), Prolonged (24h to 30 days), and Permanent (>30 days). Permissible residual limits become significantly stricter as the contact duration increases.
What is Ethylene Chlorohydrin (ECH) and why test for it?
ECH is a toxic chemical formed during EO sterilization if the device contains chlorine (like PVC). Because ECH is more persistent and often more toxic than EO itself, ISO 10993-7 sets specific limits for ECH that must be verified alongside EO levels.
Can I use data from a similar device?
While characterization can provide clues, regulatory bodies almost always require device-specific residual testing because the geometry, material density, and packaging of your specific product uniquely affect gas retention and aeration.
Contact with us
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Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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