What is BS EN ISO 10993-7:2026 - Biological Evaluation of Medical Devices - Part 7: Ethylene oxide sterilization residuals about?
BS EN ISO 10993-7:2026 sets limits and gives guidance for residual ethylene oxide and its by-products on medical devices after sterilization. It also provides methods to assess patient exposure and demonstrate compliance. This helps you support device safety and meet global regulatory expectations.
It sits within the wider BS EN ISO 10993 series for biological evaluation of medical devices and focuses on one critical issue: controlling potentially harmful residues left after ethylene oxide sterilization.
Who is BS EN ISO 10993-7:2026 - Biological Evaluation of Medical Devices - Part 7: Ethylene oxide sterilization residuals for?
This standard is for professionals involved in developing, manufacturing, approving and evaluating medical devices sterilized using ethylene oxide.
It is particularly relevant if you work in:
- medical device manufacturing;
- healthcare and hospital systems;
- pharmaceuticals and combination products;
- contract sterilization service providers;
- testing laboratories and CROs; and
- regulatory and notified bodies.
Typical roles include:
- Regulatory Affairs Manager or Specialist;
- Quality Assurance Manager or Quality Engineer;
- Sterilization Scientist or Microbiologist;
- Toxicologist or Biocompatibility Specialist;
- R&D Engineer;
- Clinical Safety or Risk Management Specialist; and
- Laboratory Testing Manager or Analytical Chemist.
What does BS EN ISO 10993-7:2026 - Biological Evaluation of Medical Devices - Part 7: Ethylene oxide sterilization residuals cover?
BS EN ISO 10993-7:2026 covers:
- acceptable limits for residual ethylene oxide and its by-products on medical devices after sterilization;
- methods for estimating patient exposure;
- guidance for demonstrating compliance;
- approaches that support consistency in testing and evaluation; and
- considerations for different types and durations of device exposure.
It complements BS EN ISO 11135 by addressing toxicological safety after sterilization, helping you consider both sterility assurance and residual safety.
Why should you use BS EN ISO 10993-7:2026 - Biological Evaluation of Medical Devices - Part 7: Ethylene oxide sterilization residuals?
You should use BS EN ISO 10993-7:2026 if you need an internationally recognized framework for managing residual ethylene oxide safely and consistently. It helps you reduce uncertainty and strengthen regulatory confidence.
Using it can help you:
- support safer use of ethylene oxide-sterilised medical devices;
- align with global regulatory requirements;
- reduce uncertainty in toxicological risk assessment;
- create greater consistency in exposure assessment;
- improve confidence across quality, regulatory, and technical teams; and
- support risk-based decision-making in device design and sterilization.
What’s changed?
BS EN ISO 10993-7:2026 is the latest edition of the standard. It was technically revised to strengthen clarity, usability, consistency and inclusivity, while maintaining the established safety framework.
Key changes include:
- Updates for special populations, including neonates and infants.
- Refined approaches to exposure assessment and allowable limits.
- Enhanced guidance on demonstrating compliance.
- Updated structure, terminology and supporting annexes aligned with the wider BS EN ISO 10993 series.