IEC 81001-5-1
International standard defining secure-product-lifecycle activities for health software, including medical devices.
Definition
IEC 81001-5-1:2021 "Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle" is the international standard that specifies secure-development-lifecycle activities applicable to health software and software-containing medical devices. It maps onto IEC 62304's software lifecycle and is the most widely cited Secure Product Development Framework (SPDF) in MedTech cybersecurity submissions.What this means in practice
Most MedTech teams pursuing global submissions are aligning their development procedures to IEC 81001-5-1 and combining it with IEC 62304 for software safety and ISO 14971 for risk management. The three together form the operating system of a modern MedTech software program.Examples
- A MedTech company is developing new diagnostic software and uses IEC 81001-5-1 to guide its secure design principles, ensuring cybersecurity considerations are integrated from the initial planning stages.
- During the software development process for a connected medical device, the engineering team performs security testing and vulnerability management activities in accordance with the practices outlined in IEC 81001-5-1.
- A regulatory submission for a novel therapeutic device includes documentation demonstrating adherence to IEC 81001-5-1, showcasing the robust secure development lifecycle applied to its embedded software.
- •Adopting 81001-5-1 on paper without integrating its activities into design reviews and design history file artifacts.
- •Treating 81001-5-1 as separate from 62304 - they're designed to interlock.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsLifecycle requirements for medical device software.
International standard for risk management of IT networks that incorporate medical devices.
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Standards Stack for Medical Devices
· From this learning pathGood clinical practice for clinical investigations of medical devices.
General requirements for basic safety and essential performance of medical electrical equipment.
EMC requirements for medical electrical equipment.
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Where this term appears across MedTech Terms.
- Standards Stack for Medical DevicesLesson 10 of 10
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1IEC 81001-5-1:2021Tier 1 VerifiedISO/IECiso.org
- 2FDA Cybersecurity Guidance (Sept 2023)Tier 2 VerifiedFDAfda.gov
- 3HSCC - Health Sector Coordinating CouncilTier 4 VerifiedHSCChealthsectorcouncil.org
Inline markers like [1] jump to the matching reference above.