FDA Announces Full Recognition of IEC 612326-2-6

On July 28, 2025, the U.S. Food and Drug Administration (FDA) updated its Recognized Consensus Standards list to include IEC 61326‑2‑6 Edition 4.0 (2025‑06),  marking complete recognition for this particular EMC (electromagnetic compatibility) standard focused on in vitro diagnostic (IVD) medical electrical equipment. This replaces the previous partial recognition of the 2020 edition.

By doing so, the FDA formally signals that compliance with this updated standard meets its expectations for EMC testing in IVD medical devices.

IEC 61326-2-6: What Is It? 

Developed by the  International Electrotechnical Commission (IEC), 61326‑2‑6 is a part-document of the broader IEC 61326 series (EMC requirements for laboratory, measurement, and control equipment). Part 2‑6 focuses exclusively on EMC testing requirements for IVD medical electrical equipment, addressing both emissions and immunity to electromagnetic disturbances. It aims to ensure:

• Basic Safety: Device safety in electromagnetic environments.
• Essential Performance: Accurate diagnostic output despite interference.

The 2025 edition introduces updated test levels and documentation requirements, reflecting advances in EMC risk understanding and laboratory conditions.

FDA’s Intent Behind Complete Recognition 

FDA’s recognition makes this standard a clear path for manufacturers to demonstrate EMC compliance in 510(k), PMA, IDE, De Novo, and other submissions. A recognized standard allows submission via Declaration of Conformity, speeding reviews and reducing uncertainties.

By formally recognizing a modern version, the FDA ensures the standard supports its risk‑based approach to EMC, especially important given prior limitations with IEC 61326‑2‑6:2020 being only partially recognized and its test levels potentially outdated.

Why This Matters

If your IVD EMC strategy still leans heavily on IEC 60601-1-2, now is the time to reassess.

This may include updating:

• Full recognition removes ambiguity: Earlier, only the 2020 version was partially recognized with exclusions; now the 2025 revision is recognized in full.
• Clearer alignment with FDA guidance: Manufacturers can rely exclusively on standardized methods and acceptance criteria defined in the 2025 standard.
• Modernized testing thresholds: The new edition may raise immunity/emission levels, requiring manufacturers to re-evaluate existing products for electromagnetic resilience.

What This Means for IVD Manufacturers

a) Premarket Submissions

Manufacturers can now reference IEC 61326‑2‑6:2025 in their premarket packages (e.g. 510(k), De Novo, PMA) to support EMC conformance with a Declaration of Conformity. This simplifies regulatory filings and may shorten review times.

b) Premarket Submissions

Test labs should transition to the 2025 test procedures and documentation style. Devices tested to the 2020 edition may need re-testing or justification to meet the new edition’s full scope.

c) Legacy Devices & Compliance Strategy

If your device was previously tested under IEC 61326‑2‑6:2020 or earlier and filings included partial recognition declarations, consider:

• Comparing test results vs. updated 2025 levels
• Conducting gap analyses
• Possibly re-testing or justifying compliance under the new threshold

d) Risk Management & Labeling
As with previous FDA guidance, manufacturers should still conduct device-specific risk assessments, define essential performance criteria, and set quantitative pass/fail thresholds aligned with FDA’s EMC guidance, especially leveraging IEC 60601‑1‑2 test levels or real-world environmental measurement

Practical Next Steps 

• Review your current EMC testing scope for IVD devices.
• Talk with your EMC laboratory to switch to IEC 61326‑2‑6:2025 protocols.
• Update your risk documentation, essential performance definitions, and pass/fail criteria in line with this edition and FDA guidance.
• Prepare revised Declarations of Conformity for regulatory submissions listing this standard and its FDA recognition number (Recognition Number 19‑57).
  

   

Closing Thoughts

FDA’s full recognition of IEC 61326‑2‑6:2025 is a meaningful milestone for IVD device developers. It offers a clear, up‑to‑date, and fully sanctioned standard for EMC testing, ensuring patient safety, device reliability, and regulatory clarity. For manufacturers, aligning with this standard now positions products for smoother approval pathways and stronger defense against EMI risks in real‑world use.

Let me know if you'd like to explore how specific IVD product categories (e.g. multiplex analyzers or point‑of‑care devices) may be affected!