--- title: "ASTM F2503, Definition | MedTech Terms" description: "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/astm-f2503#term", "name": "ASTM F2503", "description": "ASTM F2503 defines the MR Safe (green square), MR Conditional (yellow triangle), and MR Unsafe (red circle) markings used on devices and accessories in MR-equipped facilities.", "url": "https://medtechterms.com/terms/astm-f2503", "termCode": "astm-f2503", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/astm-f2503#article", "headline": "ASTM F2503", "description": "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment.", "url": "https://medtechterms.com/terms/astm-f2503", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/astm-f2503" }, "about": { "@id": "https://medtechterms.com/terms/astm-f2503#term" }, "articleSection": "Standards", "inLanguage": "en", "keywords": "ASTM F2503, 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": "ASTM F2503", "url": "https://www.astm.org/f2503-23.html", "publisher": { "@type": "Organization", "name": "ASTM" } }, { "@type": "CreativeWork", "name": "AAMI Standards", "url": "https://www.aami.org/standards", "publisher": { "@type": "Organization", "name": "AAMI" } }, { "@type": "CreativeWork", "name": "FDA Recognized Consensus Standards", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/labeling#term", "name": "Labeling", "url": "https://medtechterms.com/terms/labeling" } ] }, { "@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": "ASTM F2503", "item": "https://medtechterms.com/terms/astm-f2503" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/astm-f2503#faq", "mainEntity": [ { "@type": "Question", "name": "What are the three main classifications defined by ASTM F2503?", "acceptedAnswer": { "@type": "Answer", "text": "The standard defines three primary classifications: MR Safe (green square), MR Conditional (yellow triangle), and MR Unsafe (red circle). These icons visually communicate the device's compatibility with magnetic resonance environments." } }, { "@type": "Question", "name": "Is ASTM F2503 a mandatory standard?", "acceptedAnswer": { "@type": "Answer", "text": "While not always legally mandated, adherence to ASTM F2503 is strongly recommended and often expected by regulatory bodies like the FDA for devices intended for use in or near an MR environment. It serves as a critical tool for risk management and patient safety." } }, { "@type": "Question", "name": "Where should these markings be placed?", "acceptedAnswer": { "@type": "Answer", "text": "ASTM F2503 specifies that these markings should be prominently displayed on the device itself, its labeling, packaging, and in relevant documentation, to ensure visibility and clarity for users." } }, { "@type": "Question", "name": "Does ASTM F2503 cover all aspects of MR safety?", "acceptedAnswer": { "@type": "Answer", "text": "No, ASTM F2503 specifically addresses the marking of devices. Comprehensive MR safety also involves considerations for facility design, patient screening, and staff training, which are covered by other standards and guidelines." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ASTM F2503 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system)[Startup Lifecycle](/ecosystems/startup-lifecycle) # ASTM F2503 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ASTM F2503 defines the MR [Safe](/terms/safe-note) (green square), MR Conditional (yellow triangle), and MR Unsafe (red circle) markings used on devices and accessories in MR-equipped facilities. What the regulation says ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance (MR) Environment, provides a standardized system for [labeling](/terms/labeling) medical devices and other items to indicate their compatibility with the MR environment. This standard is recognized by regulatory bodies such as the FDA in their guidance documents concerning MR compatibility of medical devices. ## What this means in practice Required [labeling](/terms/labeling) element for any device that may enter or be used near MR scanners, including implants, monitoring equipment, and accessories. ## Examples - A pacemaker is labeled 'MR Conditional' with specific conditions, including a maximum static magnetic field strength of 1.5 Tesla and a maximum spatial gradient field of 500 Gauss/cm. - A patient undergoing an MRI has a metallic joint implant, which is correctly identified as 'MR Conditional' based on its labeling, and the imaging protocol is adjusted accordingly. - A hospital purchases new infusion pumps that are clearly marked 'MR Safe,' allowing them to be used directly within the MRI scanner room without concern for magnetic interference. Common pitfalls - • Misinterpreting 'MR Conditional' to mean a device is safe under all MR conditions, without considering the specific parameters and warnings outlined in the device's labeling. - • Failing to properly train personnel on the meaning of MR safety labels and the associated risks. - • Applying incorrect or unverified MR safety labels to devices, leading to potential harm to patients or damage to equipment. - • Not accounting for changes in a device's MR compatibility after repair or modification. ## Frequently asked questions What are the three main classifications defined by ASTM F2503? The standard defines three primary classifications: MR [Safe](/terms/safe-note) (green square), MR Conditional (yellow triangle), and MR Unsafe (red circle). These icons visually communicate the device's compatibility with magnetic resonance environments. Is ASTM F2503 a mandatory standard? Where should these markings be placed? Does ASTM F2503 cover all aspects of MR safety? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling) ### More in Standards · Same category [ 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)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ASTM· 1 AAMI· 1 FDA· 1 1. [1 ASTM F2503 Verified ASTM · astm.org ](https://www.astm.org/f2503-23.html) 2. [2 AAMI Standards Verified AAMI · aami.org ](https://www.aami.org/standards) 3. [3 FDA Recognized Consensus Standards Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) 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=astm-f2503) Learn in 60 seconds Card Lesson Quiz Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. - · Required labeling element for any device that may enter or be used near MR scanners, including implants, monitoring equipment, and accessories. Remember this Watch out: Misinterpreting 'MR Conditional' to mean a device is safe under all MR conditions, without considering the specific parameters and warnings outlined in the device's labeling. Related terms - [Labeling ](/terms/labeling) You may also need Auto-suggested from Standards and shared keywords. - [IEC 62304 ](/terms/iec-62304) - [ISO 14155 ](/terms/iso-14155) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Software Safety Case ](/terms/software-safety-case) - [Essential Performance ](/terms/essential-performance) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) [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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