--- title: "IEC 80001-1, Definition | MedTech Terms" description: "International standard for risk management of IT networks that incorporate medical devices. Plain-English Cybersecurity definition for MedTech teams, with examp" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iec-80001#term", "name": "IEC 80001-1", "alternateName": "Application of risk management for IT-networks incorporating medical devices", "description": "IEC 80001-1:2021 \"Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software\" is the foundational standard governing how Healthcare Delivery Organizations (HDOs) apply risk management to networks that include medical devices. 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The standard explicitly assigns responsibilities across manufacturers (provide accurate, timely security and network info), HDOs (run the network risk-management process), and IT vendors. Most manufacturer obligations are met through MDS2 disclosure and configuration guidance." } }, { "@type": "Question", "name": "What's in TR 80001-2-2?", "acceptedAnswer": { "@type": "Answer", "text": "Technical Report 80001-2-2 defines a common vocabulary of security capabilities (e.g., automatic logoff, audit controls, malware detection) used in disclosure documents like MDS2." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. IEC 80001-1 [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Quality System](/ecosystems/quality-system) # IEC 80001-1 International standard for risk management of IT networks that incorporate medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition IEC 80001-1:2021 "Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software" is the foundational standard governing how Healthcare Delivery Organizations (HDOs) apply risk management to networks that include medical devices. It defines roles, responsibilities, and risk-management activities shared between manufacturers, HDOs, and IT vendors. What the regulation says FDA references IEC 80001 as a relevant consensus standard for connected-device cybersecurity. Many EU Notified Bodies expect manufacturers to provide IEC 80001-aligned information (network requirements, configuration, security characteristics) to HDO operators. The 80001 series also includes technical reports on disclosure (TR 80001-2-2) and security capabilities (TR 80001-2-8). ## What this means in practice Manufacturers fulfill their IEC 80001 obligations primarily through the [MDS2](/terms/mds2) form and operator documentation. HDOs operationalize the standard through their network-risk-management process. Aligning early reduces friction with hospital biomed and security teams during procurement. Common pitfalls - • Producing operator documentation that doesn't include the security characteristics IEC 80001 expects HDOs to know. - • Confusing 80001-1 (network risk) with 81001-5-1 (product-lifecycle security) - both apply, in different roles. ## Frequently asked questions Who's responsible for IEC 80001 - manufacturer or hospital? Both. The standard explicitly assigns responsibilities across manufacturers (provide accurate, timely security and network info), HDOs (run the network risk-management process), and IT vendors. Most manufacturer obligations are met through [MDS2](/terms/mds2) disclosure and configuration guidance. What's in TR 80001-2-2? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity IEC 81001-5-1 International standard defining secure-product-lifecycle activities for health software, including medical devices. ](/terms/iec-81001-5-1)[ Cybersecurity Manufacturer Disclosure Statement for Medical Device Security(MDS2) A standardized form by which device manufacturers disclose security characteristics to healthcare delivery organizations. ](/terms/mds2)[ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b) ### More in Cybersecurity · Same category [ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ Cybersecurity AAMI TIR97(TIR97) AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Cybersecurity Brainjacking Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient. ](/terms/brainjacking) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO/IEC· 1 FDA· 1 CISA· 1 1. [1 IEC 80001-1:2021 Verified ISO/IEC · iso.org ](https://www.iso.org/standard/72026.html) 2. [2 FDA Recognized Consensus Standards Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) 3. [3 CISA - Healthcare and Public Health Sector Verified CISA · cisa.gov ](https://www.cisa.gov/topics/critical-infrastructure-security-and-resilience/critical-infrastructure-sectors/healthcare-and-public-health-sector) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [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 Cybersecurity Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=iec-80001) Learn in 60 seconds Card Lesson Quiz International standard for risk management of IT networks that incorporate medical devices. - · Manufacturers fulfill their IEC 80001 obligations primarily through the MDS2 form and operator documentation. - · HDOs operationalize the standard through their network-risk-management process. - · Aligning early reduces friction with hospital biomed and security teams during procurement. Remember this Watch out: Producing operator documentation that doesn't include the security characteristics IEC 80001 expects HDOs to know. Related terms - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) You may also need Auto-suggested from Cybersecurity and shared keywords. - [HSCC Joint Security Plan(HSCC JSP) ](/terms/hscc-jsp) - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [AAMI SW96 ](/terms/aami-sw96) - [Legacy Device Cybersecurity ](/terms/legacy-device-cyber) - [NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473) ](/terms/nist-cswp-35) - [AAMI TIR57 ](/terms/aami-tir57) [All Cybersecurity terms](/terms?cat=Cybersecurity) 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 Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.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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