IEC 62304 (Medical Software)

What IEC 62304 (Medical Software) requires

IEC 62304 is the international standard for medical device software lifecycle processes. It defines the framework of processes, activities, and tasks for the safe design and maintenance of medical software, regardless of whether the software is a standalone product (SaMD) or embedded within a hardware device.

Pillar: Medical & Healthcare · Authority: ISO (International Organization for Standardization) · Version: 1.1.0 · Last updated: 2026-04-09

Primary source: https://www.iso.org/standard/38421.html

SHA-256 integrity: 343f27811500e1a9b9f2df1501eae5066ea39b55143262255fb0de807029ccce

Primary Citations — 7 traced to source

• IEC 62304:2006+AMD1:2015, Clause 4.3 - Software safety classification (Requires assigning Class A, B, or C based on severity of potential injury).
• IEC 62304:2006+AMD1:2015, Clause 5.1 - Software development planning (Mandates a scalable software development plan linked to the safety class).

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