Guide · Medical Software
IEC 62304 — safe software for medical devices.
Software in medical devices follows a defined life cycle. How strict it must be depends on the maximum harm an error could cause.
What IEC 62304 governs
IEC 62304 defines the software life cycle processes for medical device software — from planning through development and verification to maintenance. As EN 62304 it is recognized under the EU Medical Device Regulation and is also a consensus standard in the USA.
The three safety classes
Each software element is classified according to the maximum possible harm:
- Class A — no injury or damage to health possible
- Class B — injury possible, but not serious
- Class C — death or serious injury possible
The class determines how much effort is required for documentation, design and verification. Important: even Class A is not exempt from life cycle controls — structured development and evidence are always necessary.
Interplay with EMC and risk management
IEC 62304 (software) and IEC 60601-1-2 (EMC) mesh together in the medical device — both embedded in risk management according to ISO 14971.
Frequently Asked Questions
Does IEC 62304 prescribe a specific method?
How is the safety class determined?
Sources: Greenlight Guru — IEC 62304 Classes, Jama — IEC 62304. The applicable version of the standard is authoritative.