--- title: "ISO 17665, Definition | MedTech Terms" description: "Standard for moist heat (steam) sterilization of medical devices. Plain-English Standards definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-17665#term", "name": "ISO 17665", "description": "ISO 17665 specifies the requirements for development, validation, and routine control of a moist-heat sterilization process. The 2024 revision consolidated industrial and healthcare-facility requirements.", "url": "https://medtechterms.com/terms/iso-17665", "termCode": "iso-17665", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/iso-17665#article", "headline": "ISO 17665", "description": "Standard for moist heat (steam) sterilization of medical devices.", "url": "https://medtechterms.com/terms/iso-17665", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/iso-17665" }, "about": { "@id": "https://medtechterms.com/terms/iso-17665#term" }, "articleSection": "Standards", "inLanguage": "en", "keywords": "ISO 17665, Standards, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "ISO 17665", "url": "https://www.iso.org/standard/81720.html", "publisher": { "@type": "Organization", "name": "ISO" } }, { "@type": "CreativeWork", "name": "FDA Recognized Consensus Standards", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "ISO Standards Catalogue - Health", "url": "https://www.iso.org/ics/11/x/", "publisher": { "@type": "Organization", "name": "ISO" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sterilization#term", "name": "Sterilization", "url": "https://medtechterms.com/terms/sterilization" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-11607#term", "name": "ISO 11607-1/-2", "url": "https://medtechterms.com/terms/iso-11607" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Standards", "item": "https://medtechterms.com/terms?cat=Standards" }, { "@type": "ListItem", "position": 4, "name": "ISO 17665", "item": "https://medtechterms.com/terms/iso-17665" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/iso-17665#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of ISO 17665?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to specify requirements for the development, validation, and routine control of sterilization processes for medical devices using moist heat, ensuring the sterility and safety of reprocessed items." } }, { "@type": "Question", "name": "How does ISO 17665 relate to other sterilization standards?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 17665 specifically addresses moist-heat sterilization, complementing other standards like ISO 11135 for ethylene oxide sterilization and ISO 11137 for radiation sterilization. All these standards fall under the broader quality management system requirements of ISO 13485." } }, { "@type": "Question", "name": "Who needs to comply with ISO 17665?", "acceptedAnswer": { "@type": "Answer", "text": "Medical device manufacturers, healthcare facilities, and third-party reprocessors who use moist-heat sterilization for medical devices need to comply with ISO 17665 to ensure product safety and regulatory adherence." } }, { "@type": "Question", "name": "What are the key phases of sterilization process validation under ISO 17665?", "acceptedAnswer": { "@type": "Answer", "text": "The key phases include process definition, equipment qualification (installation, operational, performance), process performance qualification, and routine monitoring and control, all supported by robust documentation." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 17665 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system)[Manufacturing & Supply](/ecosystems/manufacturing-supply) # ISO 17665 Standard for moist heat (steam) sterilization of medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 17665 specifies the requirements for development, validation, and routine control of a moist-heat [sterilization](/terms/sterilization) process. The 2024 revision consolidated industrial and healthcare-facility requirements. What the regulation says ISO 17665 is recognized by regulatory bodies worldwide as a key standard for moist-heat [sterilization](/terms/sterilization), particularly for medical devices, as noted by the FDA in its guidance on reprocessing medical devices. Compliance with this standard helps manufacturers and healthcare facilities demonstrate that their sterilization processes are effective and consistently achieve sterility, which is essential for meeting the safety requirements of regulations like the EU [MDR](/terms/mdr-reporting), Annex I, Section 17.2. ## What this means in practice Steam [sterilization](/terms/sterilization) is the workhorse of reusable surgical instruments and is referenced in reprocessing instructions for many devices. ## Examples - A MedTech manufacturer developing a new reusable surgical instrument must validate its moist-heat sterilization instructions according to ISO 17665 before placing the device on the market. - A hospital central sterile supply department (CSSD) uses ISO 17665 as a framework to ensure that its steam sterilizers are correctly operated and routinely monitored for effective sterilization of surgical trays. - An auditor reviewing a medical device manufacturer's quality management system would expect to see documented evidence of sterilization process validation in line with ISO 17665, including reports on physical, chemical, and biological indicators. Common pitfalls - • A common pitfall is failing to re-validate sterilization processes after changes to device design, packaging materials, or sterilization equipment. - • Another mistake is neglecting to establish clear process parameters and acceptance criteria for routine monitoring, leading to inconsistencies in sterilization outcomes. - • Many organizations incorrectly assume that simply purchasing ISO 17665 compliant equipment guarantees a validated process, overlooking the need for site-specific validation studies. - • Inadequate documentation of validation activities and routine monitoring records often results in non-compliance during regulatory audits. - • Failing to define and implement appropriate corrective actions when sterilization process deviations occur is a significant oversight. ## Frequently asked questions What is the primary purpose of ISO 17665? The primary purpose is to specify requirements for the development, validation, and routine control of [sterilization](/terms/sterilization) processes for medical devices using moist heat, ensuring the sterility and safety of reprocessed items. How does ISO 17665 relate to other sterilization standards? Who needs to comply with ISO 17665? What are the key phases of sterilization process validation under ISO 17665? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 11607-1/-2 Standards for sterile barrier systems for terminally sterilized medical devices. ](/terms/iso-11607)[ Manufacturing Sterilization Validated process used to render a device free from viable microorganisms. ](/terms/sterilization) ### More in Standards · Same category [ Standards ASTM F2503 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. ](/terms/astm-f2503)[ Standards Essential Performance Performance of a clinical function whose loss or degradation would result in unacceptable risk. ](/terms/essential-performance)[ Standards ICH E6(R3) Good Clinical Practice(E6(R3)) Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023. ](/terms/ich-e6-r3)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1) Cited by Where this term appears across MedTech Terms. 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 17665 Verified ISO · iso.org ](https://www.iso.org/standard/81720.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-17665) Learn in 60 seconds Card Lesson Quiz Standard for moist heat (steam) sterilization of medical devices. - · Steam sterilization is the workhorse of reusable surgical instruments and is referenced in reprocessing instructions for many devices. - · The 2024 revision consolidated industrial and healthcare-facility requirements. Remember this Watch out: A common pitfall is failing to re-validate sterilization processes after changes to device design, packaging materials, or sterilization equipment. Related terms - [Sterilization ](/terms/sterilization) - [ISO 11607-1/-2 ](/terms/iso-11607) You may also need Auto-suggested from Standards and shared keywords. - [ISO 11135 ](/terms/iso-11135) - [ISO 11137 ](/terms/iso-11137) - [Bioburden ](/terms/bioburden) - [Production and Process Controls ](/terms/production-process-controls) - [IEC 62304 ](/terms/iec-62304) - [ISO 13485 ](/terms/iso-13485) [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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)