--- title: "Standards Terms - MedTech Terms" description: "ISO, IEC, AAMI, and other consensus standards used by regulators. 22 vendor-neutral definitions with primary-source citations." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTermSet", "@id": "https://medtechterms.com/categories/standards#set", "name": "Standards - MedTech Terms", "description": "ISO, IEC, AAMI, and other consensus standards used by regulators.", "url": "https://medtechterms.com/categories/standards", "hasDefinedTerm": [ { "@type": "DefinedTerm", "name": "ASTM F2503", "url": "https://medtechterms.com/terms/astm-f2503", "termCode": "astm-f2503" }, { "@type": "DefinedTerm", "name": "Essential Performance", "url": "https://medtechterms.com/terms/essential-performance", "termCode": "essential-performance" }, { "@type": "DefinedTerm", "name": "ICH E6(R3) Good Clinical Practice", "alternateName": "E6(R3)", "url": "https://medtechterms.com/terms/ich-e6-r3", "termCode": "ich-e6-r3" }, { "@type": "DefinedTerm", "name": "IEC 60601-1", "url": "https://medtechterms.com/terms/iec-60601-1", "termCode": "iec-60601-1" }, { "@type": "DefinedTerm", "name": "IEC 60601-1-2", "url": "https://medtechterms.com/terms/iec-60601-1-2", "termCode": "iec-60601-1-2" }, { "@type": "DefinedTerm", "name": "IEC 60825", "url": "https://medtechterms.com/terms/iec-60825", "termCode": "iec-60825" }, { "@type": "DefinedTerm", "name": "IEC 62304", "url": "https://medtechterms.com/terms/iec-62304", "termCode": "iec-62304" }, { "@type": "DefinedTerm", "name": "IEC 62366-1", "url": "https://medtechterms.com/terms/iec-62366-1", "termCode": "iec-62366-1" }, { "@type": "DefinedTerm", "name": "IEC 82304-1", "url": "https://medtechterms.com/terms/iec-82304-1", "termCode": "iec-82304-1" }, { "@type": "DefinedTerm", "name": "ISO 10993-1", "url": "https://medtechterms.com/terms/iso-10993-1", "termCode": "iso-10993-1" }, { "@type": "DefinedTerm", "name": "ISO 11135", "url": "https://medtechterms.com/terms/iso-11135", "termCode": "iso-11135" }, { "@type": "DefinedTerm", "name": "ISO 11137", "url": "https://medtechterms.com/terms/iso-11137", "termCode": "iso-11137" }, { "@type": "DefinedTerm", "name": "ISO 11607-1/-2", "url": "https://medtechterms.com/terms/iso-11607", "termCode": "iso-11607" }, { "@type": "DefinedTerm", "name": "ISO 13485", "url": "https://medtechterms.com/terms/iso-13485", "termCode": "iso-13485" }, { "@type": "DefinedTerm", "name": "ISO 14155", "url": "https://medtechterms.com/terms/iso-14155", "termCode": "iso-14155" }, { "@type": "DefinedTerm", "name": "ISO 14971", "url": "https://medtechterms.com/terms/iso-14971", "termCode": "iso-14971" }, { "@type": "DefinedTerm", "name": "ISO 15223-1 Symbols", "url": "https://medtechterms.com/terms/iso-15223-1", "termCode": "iso-15223-1" }, { "@type": "DefinedTerm", "name": "ISO 17665", "url": "https://medtechterms.com/terms/iso-17665", "termCode": "iso-17665" }, { "@type": "DefinedTerm", "name": "ISO 20417", "url": "https://medtechterms.com/terms/iso-20417", "termCode": "iso-20417" }, { "@type": "DefinedTerm", "name": "ISO 22301", "url": "https://medtechterms.com/terms/iso-22301", "termCode": "iso-22301" }, { "@type": "DefinedTerm", "name": "ISO/IEC 23894", "url": "https://medtechterms.com/terms/iso-iec-23894", "termCode": "iso-iec-23894" }, { "@type": "DefinedTerm", "name": "ISO/TR 24971", "url": "https://medtechterms.com/terms/tr24971", "termCode": "tr24971" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Categories", "item": "https://medtechterms.com/categories" }, { "@type": "ListItem", "position": 3, "name": "Standards", "item": "https://medtechterms.com/categories/standards" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All categories](/categories)Category # Standards ISO, IEC, AAMI, and other consensus standards used by regulators. 22 terms [Filter in glossary](/terms?cat=Standards) ## Popular standards terms [ IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304)[ ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485)[ ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971) ## All Standards terms - [ASTM F2503 ](/terms/astm-f2503) - [Essential Performance ](/terms/essential-performance) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [IEC 60601-1 ](/terms/iec-60601-1) - [IEC 60601-1-2 ](/terms/iec-60601-1-2) - [IEC 60825 ](/terms/iec-60825) - [IEC 62304 ](/terms/iec-62304) - [IEC 62366-1 ](/terms/iec-62366-1) - [IEC 82304-1 ](/terms/iec-82304-1) - [ISO 10993-1 ](/terms/iso-10993-1) - [ISO 11135 ](/terms/iso-11135) - [ISO 11137 ](/terms/iso-11137) - [ISO 11607-1/-2 ](/terms/iso-11607) - [ISO 13485 ](/terms/iso-13485) - [ISO 14155 ](/terms/iso-14155) - [ISO 14971 ](/terms/iso-14971) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) - [ISO 17665 ](/terms/iso-17665) - [ISO 20417 ](/terms/iso-20417) - [ISO 22301 ](/terms/iso-22301) - [ISO/IEC 23894 ](/terms/iso-iec-23894) - [ISO/TR 24971 ](/terms/tr24971) ## Explore related categories [Regulatory](/categories/regulatory)[Quality & Risk](/categories/quality-and-risk)[Cybersecurity](/categories/cybersecurity)[Clinical & Trials](/categories/clinical-and-trials)[Software & AI](/categories/software-and-ai)[Manufacturing](/categories/manufacturing)[Post-Market](/categories/post-market)[Investment & Finance](/categories/investment-and-finance)[Market Segments](/categories/market-segments)[Reimbursement](/categories/reimbursement)[Commercialization](/categories/commercialization)[Industry Bodies](/categories/industry-bodies) 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)