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IEC 82304

IEC 82304-1 — Health Software Product Safety · health software safety standard

In short

Product-level safety standard for standalone health software, complementing IEC 62304's lifecycle focus.

While IEC 62304 covers the software development lifecycle, IEC 82304-1 covers product-level safety requirements for standalone health software: intended use, operating environment, accompanying information, validation, and post-market activities. It is increasingly cited alongside 62304 for SaMD CE marking.

V5 maps 82304-1 product-level evidence (validation, instructions for use, post-market) to the same dossier that holds the 62304 lifecycle artifacts.

Regulatory anchors
  • IEC 82304-1:2016
Where this term comes up
Medical Devices
How V5 handles it
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
IEC 62304SaMDIEC 62366EU MDR
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