--- title: "ISO 15223-1 Symbols, Definition | MedTech Terms" description: "Recognized graphical symbols for labels, labeling, and information supplied with medical devices. Plain-English Standards definition for MedTech teams, with exa" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-15223-1#term", "name": "ISO 15223-1 Symbols", "description": "ISO 15223-1 specifies symbols that express information about a medical device - such as manufacturer, lot number, sterilization method, and use-by date - supporting global label harmonization.", "url": "https://medtechterms.com/terms/iso-15223-1", "termCode": "iso-15223-1", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/iso-15223-1#article", "headline": "ISO 15223-1 Symbols", "description": "Recognized graphical symbols for labels, labeling, and information supplied with medical devices.", "url": "https://medtechterms.com/terms/iso-15223-1", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/iso-15223-1" }, "about": { "@id": "https://medtechterms.com/terms/iso-15223-1#term" }, "articleSection": "Standards", "inLanguage": "en", "keywords": "ISO 15223-1 Symbols, 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 15223-1:2021", "url": "https://www.iso.org/standard/77326.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/labeling#term", "name": "Labeling", "url": "https://medtechterms.com/terms/labeling" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ifu#term", "name": "Instructions for Use", "alternateName": "IFU", "url": "https://medtechterms.com/terms/ifu" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/udi#term", "name": "Unique Device Identification", "alternateName": "UDI", "url": "https://medtechterms.com/terms/udi" } ] }, { "@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 15223-1 Symbols", "item": "https://medtechterms.com/terms/iso-15223-1" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/iso-15223-1#faq", "mainEntity": [ { "@type": "Question", "name": "Are ISO 15223-1 symbols mandatory for all MedTech products?", "acceptedAnswer": { "@type": "Answer", "text": "While not always strictly mandatory for all products, ISO 15223-1 symbols are widely adopted and recognized by regulatory bodies worldwide, including the FDA and those overseeing the EU MDR. 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They reduce the need for multiple language translations on the label itself, but do not eliminate the need for detailed written information, such as in the Instructions For Use (IFU), which often defines the symbols used." } } ] } ] } --- [ 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 15223-1 Symbols [All terms](/terms) Standards [Quality System](/ecosystems/quality-system) # ISO 15223-1 Symbols Recognized graphical symbols for labels, labeling, and information supplied with medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 15223-1 specifies symbols that express information about a medical device - such as manufacturer, lot number, [sterilization](/terms/sterilization) method, and use-by date - supporting global label harmonization. What the regulation says Regulators like the FDA and those operating under the EU [MDR](/terms/mdr-reporting) recognize ISO 15223-1 symbols as an alternative to written text on medical device [labeling](/terms/labeling), provided certain conditions are met, to streamline global market access and ensure clear communication of critical information. The standard helps fulfill essential requirements regarding information supplied by the manufacturer, as detailed in EU MDR Annex I, Chapter III, Section 23. ## What this means in practice Both EU [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) and FDA recognize ISO 15223-1 symbols in lieu of explanatory text under specified conditions, simplifying multi-region [labeling](/terms/labeling). ## Examples - A manufacturer uses the "LOT" symbol followed by a unique alphanumeric code to indicate the batch number on a sterile surgical instrument package. - The "Do Not Reuse" symbol, as defined in ISO 15223-1, is prominently displayed on single-use catheters to prevent re-sterilization and potential patient harm. - A medical device company includes the "Manufacturer" symbol next to its corporate logo on the device packaging to clearly identify the responsible entity. Common pitfalls - • Failing to provide definitions for symbols in accompanying documentation (e.g., Instructions For Use) can lead to non-compliance. - • Using symbols inconsistently across different product lines or regions creates confusion and potential regulatory issues. - • Assuming all symbols are universally understood without considering country-specific regulations or user demographics is a common mistake. - • Neglecting to keep symbol usage updated with the latest revisions of ISO 15223-1 can result in outdated labeling. - • Poor legibility or incorrect placement of symbols on the label can render them ineffective or misleading. ## Frequently asked questions Are ISO 15223-1 symbols mandatory for all MedTech products? While not always strictly mandatory for all products, ISO 15223-1 symbols are widely adopted and recognized by regulatory bodies worldwide, including the FDA and those overseeing the EU [MDR](/terms/mdr-reporting). Their use often simplifies compliance and improves global market acceptance. Can I create my own symbols if they are not in ISO 15223-1? How do ISO 15223-1 symbols relate to other labeling requirements? ## Cross-references ### Used by Things that build on this term. - [ Labeling ](/terms/labeling) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Instructions for Use(IFU) Information supplied by the manufacturer to inform the user of safe use of a device. ](/terms/ifu)[ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi) ### 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 (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 FDA· 1 1. [1 ISO 15223-1:2021 Verified ISO · iso.org ](https://www.iso.org/standard/77326.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-15223-1) Learn in 60 seconds Card Lesson Quiz Recognized graphical symbols for labels, labeling, and information supplied with medical devices. - · Both EU MDR/IVDR and FDA recognize ISO 15223-1 symbols in lieu of explanatory text under specified conditions, simplifying multi-region labeling. Remember this Watch out: Failing to provide definitions for symbols in accompanying documentation (e.g., Instructions For Use) can lead to non-compliance. Related terms - [Labeling ](/terms/labeling) - [Instructions for Use(IFU) ](/terms/ifu) - [Unique Device Identification(UDI) ](/terms/udi) You may also need Auto-suggested from Standards and shared keywords. - [ISO 20417 ](/terms/iso-20417) - [Single-Use Device(SUD) ](/terms/single-use-device) - [IEC 60825 ](/terms/iec-60825) - [IEC 62366-1 ](/terms/iec-62366-1) - [ISO 11135 ](/terms/iso-11135) - [ISO 11137 ](/terms/iso-11137) [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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