Bottom line: many will assume this removes the burden of IEC 60601-1-2 compliance. The reality is more nuanced. Parts of 60601-1-2 were incorporated into the updated 61326-2-6, and Essential Performance and risk management remain critical. The FDA 2022 EMC Guidance still applies.

The technical reality – 4 key takeaways

Global implications

IEC 61326-2-6:2025 applies internationally, not just in the United States. Update your compliance strategy across markets, not only for FDA submissions.

What manufacturers should do now

If your EMC test plans, risk analysis, or labeling still reference IEC 60601-1-2 or IEC 61326-2-6:2020 for IVDs, it’s time to recheck your EMC strategy ✔️

• Refresh your risk management file and test plans to align with 61326-2-6:2025.
• Train teams on how Essential Performance still factors into acceptance criteria and test objectives.
• Anticipate ripple effects from CISPR 11:2024 when 61326-1 updates land.

Keep the Conversation Going

Continue the discussion on LinkedIn:

Useful references

• Scott Colburn’s FDA announcement
• FDA Recognized Standards update (IEC 61326-2-6 Edition 4.0, 2025-06)

At Eisner Safety Consultants, we have multiple EMC experts ready to support you. If you’d like to schedule a free 30-minute meeting with me, Leo, The IEC 601 Guy, to discuss your needs, I’d be glad to help.

Explore more insights on my blog: Standards Updates or see my previous Podcasts.