--- title: "Sterilization, Definition | MedTech Terms" description: "Validated process used to render a device free from viable microorganisms. Plain-English Manufacturing definition for MedTech teams, with examples and related t" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sterilization#term", "name": "Sterilization", "description": "Sterilization is a validated process used to render a product free from viable microorganisms. 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Sterilization [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply) # Sterilization Validated process used to render a device free from viable microorganisms. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Sterilization is a validated process used to render a product free from viable microorganisms. Common modalities include ethylene oxide (EO), gamma radiation, electron beam, and steam. What the regulation says Under the EU [MDR](/terms/mdr-reporting) 2017/745, Annex I, Section 11.2 states that devices delivered in a sterile condition must be designed, manufactured, and packed in a non-reusable pack or according to appropriate procedures to ensure they are sterile at the time of use and that sterility is maintained during transport and storage. The FDA, under 21 CFR 820.30, mandates that manufacturers establish and maintain procedures to control product design to ensure that specified design requirements are met, which includes sterilization parameters for sterile devices. [ISO 11135](/terms/iso-11135), [ISO 11137](/terms/iso-11137) (parts 1-3), and [ISO 17665](/terms/iso-17665) (parts 1-2) further provide specific requirements for the development, validation, and routine control of sterilization processes for medical devices using ethylene oxide, radiation, and moist heat, respectively. ## What this means in practice FDA has prioritized reducing EO use due to environmental concerns, accelerating adoption of alternative modalities under [ISO 11135](/terms/iso-11135) and related standards. ## Examples - A manufacturer of a novel surgical instrument validates its sterilization process using gamma radiation, following ISO 11137-1 guidelines, to ensure the device is sterile when reaching the operating room. - A company manufacturing pre-filled syringes must validate their moist heat sterilization process according to ISO 17665 to ensure the sterility and stability of the drug-device combination product. - Prior to launching a new catheter, the MedTech company performs extensive biocompatibility testing and material compatibility studies to confirm the chosen ethylene oxide sterilization method does not degrade the device or leave harmful residues, adhering to ISO 10993 standards. Common pitfalls - • Failing to re-validate sterilization processes after significant product or process changes can lead to non-sterile devices. - • Assuming a sterilization method validated for one device material or design is automatically suitable for another can result in sterilization failures. - • Inadequate documentation of sterilization validation and routine process control can lead to regulatory non-compliance during audits. - • Choosing a sterilization modality solely based on cost without considering material compatibility and biological safety can compromise device integrity and patient safety. - • Not performing routine biological indicator testing or dose audits can obscure a failing sterilization process until a recall is necessary. ## Frequently asked questions How does sterilization differ from disinfection? Sterilization is a process that destroys or eliminates all forms of microbial life, including highly resistant bacterial spores. Disinfection, conversely, reduces the number of viable microorganisms on a surface or in a product but does not necessarily eliminate all microbial forms, especially spores. What is a 'validated process' in the context of sterilization? Why is ethylene oxide (EO) sterilization facing scrutiny? What role do standards like ISO 11135 play? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Process Validation Establishing documented evidence that a process consistently produces conforming output. ](/terms/process-validation) ### 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). ](/terms/cleanroom-iso-14644?from=manufacturing-and-supply-chain)[ Manufacturing Design Transfer Translating design into production specifications. ](/terms/design-transfer?from=manufacturing-and-supply-chain)[ Quality & Risk IQ / OQ / PQ Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification. Adjacent lesson ](/terms/iq-oq-pq?from=manufacturing-and-supply-chain)[ Standards ISO 11135 Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. Adjacent lesson ](/terms/iso-11135?from=manufacturing-and-supply-chain) ### More in Manufacturing · Same category [ Manufacturing Lot Traceability Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number. ](/terms/lot-traceability)[ Manufacturing Stability Testing Studies that establish how device performance and packaging hold up over time. ](/terms/stability-testing)[ Manufacturing Supplier Controls Procedures to ensure purchased products and services conform to requirements. ](/terms/supplier-controls) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Manufacturing & Supply Chain](/paths/manufacturing-and-supply-chain)Lesson 3 of 14 Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Mentioned in recent activity 15 entries FDA 510(k) (3)Recalls (10)PubMed (2) [Dukal Crepe Paper Sterilization Wrap ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252823) Dukal, LLC · 2026-05-28 [HALYARD\* ONE-STEP\* Sterilization Wrap; HALYARD\* QUICK CHECK\* Sterilization Wrap; HALYARD\* SEQUENTIAL Sterilization Wrap; HALYARD\* SMART-FOLD\* Sterilization Wrap ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454) O&M Halyard, Inc. · 2026-05-18 [STERRAD 100NX Sterilization System with ALLClear Technology (10104) ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252843) Advanced Sterilization Products, Inc. · 2026-04-15 ## Latest in MedTech [View all](/latest?term=sterilization) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-06-01 [Sterilization and High-Level Disinfection in 2026: New and Emerging Topics. ](https://pubmed.ncbi.nlm.nih.gov/41813523/) Infectious disease clinics of North America - 510(k) 2026-05-28 [Dukal Crepe Paper Sterilization Wrap ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252823) Dukal, LLC - 510(k) 2026-05-18 [HALYARD\* ONE-STEP\* Sterilization Wrap; HALYARD\* QUICK CHECK\* Sterilization Wrap; HALYARD\* SEQUENTIAL Sterilization Wrap; HALYARD\* SMART-FOLD\* Sterilization Wrap ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454) O&M Halyard, Inc. ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 ISO· 1 IMDRF/GHTF· 1 1. [1 FDA Sterilization Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices) 2. [2 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) 3. [3 GHTF/IMDRF Process Validation Guidance Verified IMDRF/GHTF · imdrf.org ](https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [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 Manufacturing Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=sterilization) Learn in 60 seconds Card Lesson Quiz Validated process used to render a device free from viable microorganisms. - · FDA has prioritized reducing EO use due to environmental concerns, accelerating adoption of alternative modalities under ISO 11135 and related standards. - · Common modalities include ethylene oxide (EO), gamma radiation, electron beam, and steam. Remember this Watch out: Failing to re-validate sterilization processes after significant product or process changes can lead to non-sterile devices. Related terms - [Process Validation ](/terms/process-validation) You may also need Auto-suggested from Manufacturing and shared keywords. - [ISO 11137 ](/terms/iso-11137) - [Bioburden ](/terms/bioburden) - [ISO 11135 ](/terms/iso-11135) - [Process Capability and Cpk ](/terms/process-capability-cpk) - [Technology Transfer (Manufacturing) ](/terms/tech-transfer) - [ISO 17665 ](/terms/iso-17665) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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