IEC 62304 vs IEC 81001-5-1
IEC 62304 addresses medical device software lifecycle processes. IEC 81001-5-1 addresses secure health-software lifecycle activities.
Side-by-side breakdown
| Dimension | IEC 62304 | IEC 81001-5-1 |
|---|---|---|
| Scope | Software lifecycle processes for medical device software. | Health software security activities across the lifecycle. |
| Current edition | IEC 62304:2006/AMD1:2015. | IEC 81001-5-1:2021. |
| Safety classification | Class A / B / C by potential harm. | Risk-based; layers on top of 62304 safety class. |
| Activities | Planning, requirements, architecture, detailed design, implementation, verification, release, maintenance. | Secure-by-design, threat modeling, vulnerability management, security testing, secure update, postmarket monitoring. |
| FDA recognition | Recognized consensus standard. | Recognized; cited in 2026 premarket guidance as the SPDF underpinning. |
| Relationship | Foundational SDLC standard. | Cybersecurity overlay that maps each activity to a 62304 lifecycle stage. |
When to use which
Update your software development plan to reference both standards. Every 62304 activity should have an 81001-5-1 cybersecurity counterpart - design review includes threat-model review, verification includes security testing, release includes SBOM generation.
Review actual implementation as well as documents. Identify gaps in security requirements, threat modeling, testing, vulnerability handling, and maintenance; existing software procedures do not establish that security activities are performed.
Frequently asked questions
Keep exploring
Secure your device before it reaches patients.
30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.