--- title: "ISO 11135, Definition | MedTech Terms" description: "Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 11135 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system)[Manufacturing & Supply](/ecosystems/manufacturing-supply) # ISO 11135 Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 11135 specifies requirements for EO [sterilization](/terms/sterilization) processes for medical devices, including microbiological qualification, dose setting, process challenge devices, and parametric release options. What the regulation says ISO 11135:2014 specifies the requirements for the development, validation, and routine control of an ethylene oxide [sterilization](/terms/sterilization) process for medical devices. The standard outlines the requirements for equipment, process control, and validation to ensure the sterility assurance level (SAL) for terminally sterilized medical devices in accordance with national and international regulations, such as those overseen by the FDA and the EU [MDR](/terms/mdr-reporting). It does not specify requirements for developing, validating, and routinely controlling a process for inactivating the causative agents of spongiform encephalopathies or other unconventional agents. ## What this means in practice EO [sterilization](/terms/sterilization) capacity has been a persistent supply-chain risk; ISO 11135 conformance is essential to qualify alternative sites. ## Examples - A manufacturer validates an ethylene oxide sterilization cycle for a new surgical implantable device, ensuring all parameters meet ISO 11135 requirements, such as gas concentration, exposure time, temperature, and humidity. - During a regulatory audit, a medical device company demonstrates compliance with ISO 11135 by presenting documentation for routine biological indicator testing and equipment calibration records for their ethylene oxide sterilizer. - A contract sterilizer develops a process challenge device (PCD) that accurately represents the most difficult-to-sterilize product within a load, as mandated by ISO 11135, for ongoing sterilization monitoring. Common pitfalls - • A common pitfall is the failure to re-validate the sterilization process after changes to the product, packaging, or equipment, which can compromise sterility assurance. - • Another mistake is neglecting to perform routine biological indicator testing or chemical indicator monitoring, leading to undetected sterilization failures. - • Assuming that a generic sterilization cycle is appropriate for all devices, without specific validation for each product, can result in inadequate sterilization. - • Improper storage and handling of ethylene oxide gas cylinders or sterilized products can compromise sterility and safety. - • Not adequately training personnel involved in the sterilization process can lead to procedural errors and non-compliance with the standard. ## Frequently asked questions What is the primary purpose of ISO 11135? The primary purpose of ISO 11135 is to provide requirements for the development, validation, and routine control of an ethylene oxide [sterilization](/terms/sterilization) process for medical devices, ensuring product safety and efficacy. Who needs to comply with ISO 11135? Does ISO 11135 cover all sterilization methods? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Sterilization Validated process used to render a device free from viable microorganisms. ](/terms/sterilization)[ Standards ISO 11137 Standard for radiation sterilization of healthcare products. ](/terms/iso-11137) ### Standards Stack for Medical Devices · From this learning path [ Standards ISO 10993-1 Biological evaluation of medical devices within a risk management process. Adjacent lesson ](/terms/iso-10993-1?from=standards-stack)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. Adjacent lesson ](/terms/iso-14155?from=standards-stack)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1?from=standards-stack)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2?from=standards-stack) ### Manufacturing & Supply Chain · From this learning path [ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). Adjacent lesson ](/terms/cleanroom-iso-14644?from=manufacturing-and-supply-chain)[ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility?from=manufacturing-and-supply-chain)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control?from=manufacturing-and-supply-chain)[ Manufacturing Design Transfer Translating design into production specifications. ](/terms/design-transfer?from=manufacturing-and-supply-chain) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [Standards Stack for Medical Devices](/paths/standards-stack)Lesson 8 of 10 - [Manufacturing & Supply Chain](/paths/manufacturing-and-supply-chain)Lesson 4 of 14 Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 FDA· 1 1. [1 ISO 11135 Verified ISO · iso.org ](https://www.iso.org/standard/56137.html) 2. [2 FDA Recognized Consensus Standards Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) 3. [3 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Standards Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=iso-11135) Learn in 60 seconds Card Lesson Quiz Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. - · EO sterilization capacity has been a persistent supply-chain risk; ISO 11135 conformance is essential to qualify alternative sites. Remember this Watch out: A common pitfall is the failure to re-validate the sterilization process after changes to the product, packaging, or equipment, which can compromise sterility assurance. Related terms - [Sterilization ](/terms/sterilization) - [ISO 11137 ](/terms/iso-11137) You may also need Auto-suggested from Standards and shared keywords. - [ISO 17665 ](/terms/iso-17665) - [ISO 11607-1/-2 ](/terms/iso-11607) - [Production and Process Controls ](/terms/production-process-controls) - [IEC 62304 ](/terms/iec-62304) - [Bioburden ](/terms/bioburden) - [Change Control ](/terms/change-control) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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