Analysis of sterilization residues using EtO according to ISO 10993-7
Healthcare industry professionals: would you like to verify the compliance of your devices with ISO 10993-7?
What is ISO 10993-7?
Ethylene oxide and ethylene chlorohydrin sterilization are widely used methods due to their microbiological effectiveness. These sterilization processes are used in particular for medical devices and pharmaceutical product packaging and delivery systems that cannot withstand traditional high-temperature steam sterilization, such as single-use medical devices, for example.
Thus, ISO 10993-7, “Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals,” is an international standard relating to the sterilization of finished products. It enables the measurement of sterilization residues in medical devices sterilized with ethylene oxide and ethylene chlorohydrin, and verification of the maximum removal of residues of these chemicals.
The challenges of ISO 10993-7
Unlike other pollutants, the limits for EtO are non-negotiable. The standard defines maximum permissible doses for two key substances:
- Ethylene Oxide (EtO): the sterilizing gas itself.
Ethylene Chlorohydrin (ECH): a toxic reaction by-product formed in the presence of chlorides, often found in PVC.
Our expertise in analysis and desorption
We help you validate your sterilization cycles and desorption (aeration) times through a rigorous analytical protocol.
Determining the exposure category
The standard adjusts the limits according to the length of time the device is in contact with the patient:
Limited exposure: cumulative contact of < 24 hours.
Prolonged exposure: contact between 24 hours and 30 days.
Permanent exposure: contact > 30 days.
Sensitive analytical techniques
GC-FID: A Robust Method for Quantification
Gas chromatography coupled with a flame ionization detector (GC-FID) is particularly well suited to the analysis of volatile organic compounds such as EtO, ECH and EG.
It provides:
- accurate and reproducible quantification
- good sensitivity for volatile compounds
- analytical robustness suitable for routine analysis
GC-MS: Compound Identification and Confirmation
Gas chromatography coupled with mass spectrometry (GC-MS) provides additional information.
It enables:
- the formal identification of molecules through their spectral signatures
- the confirmation of detected compounds
- the detection of very low traces or unexpected compounds
FILAB supports you in the analysis of ethylene oxide according to ISO 10993-7
Why choose FILAB for analysis according to ISO 10993-7
As experts in the analysis of trace-level organic substances, FILAB laboratory supports you at every stage of validating your industrial processes, particularly sterilization processes.
Our specialists have developed specific methods for measuring Ethylene Oxide and Ethylene Chlorohydrin in Medical Devices. The analysis is performed by exhaustive extraction to recover all residues. Quantification is carried out by HS\/GCMS (Headspace Injection followed by Gas Chromatography coupled with Mass Spectrometry).
Our other analytical services according to ISO 10993
Our other analytical services
R&D support: tailor-made chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Problem solving: non-conformity, failure, adhesion, corrosion...
Our FAQ
Cytotoxicity (ISO 10993-5) is a rapid screening test that indicates whether cells die upon contact with the device. However, it does not detect long-term risks such as carcinogenicity, reproductive toxicity, or systemic effects associated with the accumulation of small doses of leachable substances. ISO 10993-17 provides rigorous scientific evidence that the released dose is safe for humans throughout the product’s entire service life.
Yes. Although the requirements are more stringent for implants (permanent contact), any medical device that comes into contact with the patient must undergo chemical characterization. If substances migrate into the patient, a toxicological assessment is required to conclude biological safety, in accordance with European Regulation MDR 2017/745.
Ethylene Chlorohydrin (ECH) is a reaction by-product formed when ethylene oxide comes into contact with chloride ions (present in PVC, certain adhesives, or salts). ECH is extremely toxic and often persists longer than EtO in materials. Monitoring it is therefore essential for patient safety.
The analysis mainly cover:
ethylene oxide (ETO)
ethylene chlorohydrin (ECH)
ethylene glycol (EG)
Other compounds may be investigated depending on the context and materials.
To request a quote, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (material type, requested analysis, applicable standard, urgency, number of samples, etc.). We will then send you a personalized technical and pricing proposal within 24–48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the testing project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
