--- title: "ISO/IEC 23894, Definition | MedTech Terms" description: "Guidance on AI-specific risk management for organizations developing or using AI systems. Plain-English Standards definition for MedTech teams, with examples an" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-iec-23894#term", "name": "ISO/IEC 23894", "description": "ISO/IEC 23894:2023 provides AI-specific guidance on risk management aligned with ISO 31000, addressing risks unique to AI such as bias, opacity, data drift, and autonomy.", "url": "https://medtechterms.com/terms/iso-iec-23894", "termCode": "iso-iec-23894", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/iso-iec-23894#article", "headline": "ISO/IEC 23894", "description": "Guidance on AI-specific risk management for organizations developing or using AI systems.", "url": "https://medtechterms.com/terms/iso-iec-23894", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/iso-iec-23894" }, "about": { "@id": "https://medtechterms.com/terms/iso-iec-23894#term" }, "articleSection": "Standards", "inLanguage": "en", "keywords": "ISO/IEC 23894, 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/IEC 23894:2023", "url": "https://www.iso.org/standard/77304.html", "publisher": { "@type": "Organization", "name": "ISO" } }, { "@type": "CreativeWork", "name": "ISO Standards Catalogue - Health", "url": "https://www.iso.org/ics/11/x/", "publisher": { "@type": "Organization", "name": "ISO" } }, { "@type": "CreativeWork", "name": "IEC Webstore - Medical Equipment", "url": "https://webstore.iec.ch/searchform&q=medical", "publisher": { "@type": "Organization", "name": "IEC" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-14971#term", "name": "ISO 14971", "url": "https://medtechterms.com/terms/iso-14971" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eu-ai-act#term", "name": "EU AI Act", "url": "https://medtechterms.com/terms/eu-ai-act" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-ml-device#term", "name": "AI/ML-Enabled Medical Device", "url": "https://medtechterms.com/terms/ai-ml-device" } ] }, { "@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/IEC 23894", "item": "https://medtechterms.com/terms/iso-iec-23894" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/iso-iec-23894#faq", "mainEntity": [ { "@type": "Question", "name": "How does ISO/IEC 23894 relate to ISO 14971 for medical AI?", "acceptedAnswer": { "@type": "Answer", "text": "ISO/IEC 23894 provides guidance on AI-specific risks like bias and opacity, while ISO 14971 focuses on risks related to patient harm from medical devices. 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It is particularly helpful for narrative conformity under emerging regulations like the EU AI Act, which emphasizes trustworthy AI." } } ] } ] } --- [ 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/IEC 23894 [All terms](/terms) Standards [AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system) # ISO/IEC 23894 Guidance on AI-specific risk management for organizations developing or using AI systems. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO/IEC 23894:2023 provides AI-specific guidance on risk management aligned with [ISO 31000](/terms/iso-31000), addressing risks unique to AI such as bias, opacity, data drift, and autonomy. What the regulation says ISO/IEC 23894:2023 offers specific guidance for managing risks associated with artificial intelligence systems, complementing general risk management principles outlined in [ISO 31000](/terms/iso-31000). It addresses AI-specific risks such as algorithmic bias, lack of transparency (opacity), data drift, and autonomous decision-making, which are crucial considerations for regulatory bodies like the European Commission in the context of the [EU AI Act](/terms/eu-ai-act). ## What this means in practice Often used alongside [ISO 14971](/terms/iso-14971) for medical AI: 14971 covers patient harm; 23894 broadens to organizational and AI-system risks. Helpful for [EU AI Act](/terms/eu-ai-act) conformity narratives. ## Examples - A medical device manufacturer uses ISO/IEC 23894:2023 to identify and mitigate risks associated with an AI-powered diagnostic tool, such as potential diagnostic bias across different demographic groups. - During the development of an AI-driven surgical robot, the development team applies ISO/IEC 23894:2023 principles to assess and manage risks related to the AI system's autonomous decision-making in unforeseen scenarios. - A company developing an AI algorithm for predictive analytics in patient care utilizes ISO/IEC 23894:2023 to address risks of data drift that could lead to decreased accuracy over time and implement continuous monitoring strategies. Common pitfalls - • A common pitfall is to apply ISO/IEC 23894:2023 in isolation, neglecting essential medical device risk management standards such as ISO 14971:2019. - • Organizations may mistakenly believe that addressing AI-specific risks under ISO/IEC 23894:2023 fully covers all safety and performance requirements for medical AI. - • Failing to integrate the risk management processes outlined in ISO/IEC 23894:2023 with the overall quality management system, as required by standards like 21 CFR Part 820, can lead to compliance gaps. - • Overlooking the need for continuous monitoring and post-market surveillance of AI systems to detect and mitigate emerging risks not identified during initial risk assessment is a significant oversight. - • Another pitfall is to narrowly interpret "risk" solely as patient harm, ignoring financial, reputational, or societal risks that ISO/IEC 23894:2023 aims to address. ## Frequently asked questions How does ISO/IEC 23894 relate to ISO 14971 for medical AI? ISO/IEC 23894 provides guidance on AI-specific risks like bias and opacity, while [ISO 14971](/terms/iso-14971) focuses on risks related to patient harm from medical devices. For medical AI, both standards are critical, with ISO 14971 addressing patient safety and ISO/IEC 23894 expanding to broader AI system and organizational risks. What types of risks does ISO/IEC 23894 primarily address? Is ISO/IEC 23894 mandatory for AI in MedTech? ## Cross-references ### Overlaps with Covers some of the same ground; not interchangeable. - [ ISO 14971 ](/terms/iso-14971) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971)[ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device)[ Software & AI EU AI Act EU regulation establishing risk-based requirements for AI systems, including most medical AI. ](/terms/eu-ai-act) ### 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) - [AI / ML in Devices](/ecosystems/ai-ml) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 IEC· 1 1. [1 ISO/IEC 23894:2023 Verified ISO · iso.org ](https://www.iso.org/standard/77304.html) 2. [2 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) 3. [3 IEC Webstore - Medical Equipment Verified IEC · webstore.iec.ch ](https://webstore.iec.ch/searchform&q=medical) 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-iec-23894) Learn in 60 seconds Card Lesson Quiz Guidance on AI-specific risk management for organizations developing or using AI systems. - · Often used alongside ISO 14971 for medical AI: 14971 covers patient harm; 23894 broadens to organizational and AI-system risks. - · Helpful for EU AI Act conformity narratives. Remember this Watch out: A common pitfall is to apply ISO/IEC 23894:2023 in isolation, neglecting essential medical device risk management standards such as ISO 14971:2019. Related terms - [ISO 14971 ](/terms/iso-14971) - [EU AI Act ](/terms/eu-ai-act) - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) You may also need Auto-suggested from Standards and shared keywords. - [ISO/TR 24971 ](/terms/tr24971) - [Threat Modeling ](/terms/threat-modeling) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [HSCC Joint Security Plan(HSCC JSP) ](/terms/hscc-jsp) - [ISO 31000 ](/terms/iso-31000) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) [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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