Get your medical devices cleared for the US market — EMC testing for your FDA 510(k) submission
EMC testing, anticipating emerging FDA requirements
Groupe Emitech supports manufacturers, importers and distributors of medical devices in their US market access process. For any device subject to the FDA 510(k) pathway, your submission must demonstrate electromagnetic compatibility — both in compliance with FDA-recognized standards and by anticipating risks from emerging technologies (5G, Wi-Fi 6E, Wi-Fi 7).
The FDA guidance of June 2022 explicitly requires manufacturers to identify and technically justify EM risks related to the real-use environment of their device, including when no standard yet covers those risks. Our laboratories carry out all required EMC tests and coordinate your complete technical file in accordance with ANSI/AAMI/IEC 60601-1-2, IEC TS 60601-4-2 and AIM Standard 7351731.
Medical devices we test
We cover all categories of medical devices subject to FDA EMC requirements:
- In vitro diagnostic devices: laboratory analyzers (hematology, biochemistry), diagnostic automated systems
- Patient monitoring devices: monitors, connected wearable sensors
- Home care devices: connected consumer-grade equipment for medical use
- Devices with wireless functionality: RFID, Bluetooth, Wi-Fi, and where applicable 5G
- Devices considered "susceptible" under FDA guidance, whose use environment involves RFID readers or specific EM emitters
Our EMC testing services for your medical device
Normative EMC testing (IEC 60601-1-2 / ANSI-AAMI-IEC 60601-1-2)
Our laboratories carry out all emission and immunity tests required by the IEC 60601-1-2 collateral standard and its FDA-recognized version for the US and Canadian markets (ANSI/AAMI/IEC 60601-1-2: 2014/AMD1: 2021):
- Conducted and radiated emissions (per the emission requirements defined in the standard, with reference to CISPR 11 for ISM Group 1 equipment)
- Immunity to electrostatic discharge, electrical fast transients, surges
- Immunity to radiated and conducted radio-frequency electromagnetic fields
- Immunity to magnetic fields (power frequency and near-field)
- Review of technical documentation and test plan (Annex G)
- Testing per IEC TS 60601-4-2: 2024 (formerly IEC TR 60601-4-2), which supplements IEC 60601-1-2 on performance related to the claimed medical intended use — partially recognized by the FDA (Rec# 19-50)
Anticipating emerging frequency bands (5G, Wi-Fi 6E, Wi-Fi 7)
Standardized radiated immunity tests currently cover frequencies up to 6 GHz, whereas 5G FR2, Wi-Fi 6E and Wi-Fi 7 operate in higher bands. In the absence of any officially applicable normative framework, our teams apply a methodology consistent with existing medical standards: same modulation types, field levels derived from the IEC 60601-1-2 reference immunity level (10 V/m to 28 V/m depending on environmental severity), applied to the relevant frequencies.
This approach enables the preparation of a technically justified and traceable file — precisely what the FDA guidance of June 2022 requires from manufacturers when no standard yet covers an identified EM risk in the real-use environment.
Wireless coexistence and common EM emitters
Beyond the product standard, the FDA expects a demonstration of immunity to electromagnetic emitters present in the real-use environment:
- Wireless coexistence (ANSI C63.27) — for devices incorporating Bluetooth, Wi-Fi 2.4/5 GHz or DECT, to verify continued operation in the presence of competing signals
- Common emitters (ANSI C63.18) — walkie-talkies, mobile radios, cellular phones, nearby RFID badges
- Medical-specific emitters — electrosurgical units, diathermy, MRI
- Wireless power transfer (WPT) and anti-theft systems / metal detectors, depending on the risk profile of your device
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RFID and NFC immunity (AIM Standard 7351731)
For medical devices that may be exposed to RFID readers in their use environment, we test immunity in accordance with AIM Standard 7351731, covering common protocols and frequencies (134.2 kHz to 2.45 GHz), explicitly recognized by the FDA (Rec# 43129). This standard applies to any electromedical equipment for which the presence of RFID readers constitutes an identified risk, and is particularly recommended for safety-critical or susceptible devices as defined in FDA guidance.
Human exposure to electromagnetic fields (IEC 62311)
We also assess compliance of your devices with human exposure limits for electromagnetic fields (0 Hz – 300 GHz) per IEC 62311: 2019. This standard should be incorporated into your overall risk analysis as a complement to EMC testing, particularly for devices that intentionally emit RF fields (Wi-Fi, Bluetooth, integrated RFID).
An approach rooted in FDA risk management philosophy
The FDA does not systematically require additional testing: it wants to verify that the risk has been identified, analyzed and technically justified. Our experts help you build this demonstration — through testing or risk analysis, whichever is most appropriate for your product.
By integrating these tests directly into our service offering whenever a client targets the US market, we reduce the risk of delays caused by an Additional Information Request during the 510(k) review process.
Our test equipment for medical devices
- High-frequency RF antennas and generators — Coverage up to 40 GHz, enabling radiated immunity testing at frequencies not yet covered by current standards (5G FR2, Wi-Fi 6E/7)
- High-precision motorized mast — Repurposed from radiofrequency measurements up to 140 GHz; automated near-field scanning (tests at approximately 5 cm from the product) for homogeneous and reproducible exposure
- Anechoic chamber — Radiated immunity testing over the full surface of the equipment
Key normative references
- ANSI/AAMI/IEC 60601-1-2: 2014/AMD1: 2021 — FDA-recognized (Rec# 19-53, Complete)
- IEC TS 60601-4-2: 2024 — Guidelines and interpretation, electromagnetic immunity — FDA-recognized (Rec# 19-50, Partial)
- AIM Standard 7351731 Rev.3: 2022 — Immunity to RFID readers — FDA-recognized (Rec# 43129)
- ANSI C63.27: 2017 — Evaluation of wireless coexistence — FDA-recognized
- ANSI C63.18: 2014 — On-site ad hoc test method for estimating EM immunity — FDA-recognized (Rec# 19-17)
- IEC 62311: 2019 — Human exposure to electromagnetic fields (0 Hz – 300 GHz)
- FDA Guidance "Electromagnetic Compatibility (EMC) of Medical Devices — Guidance for Industry and FDA Staff", June 2022
- CISPR 11 — Conducted and radiated emission measurements, applicable to ISM Group 1 equipment
Why choose Groupe Emitech for your medical device EMC testing?
- Expertise built on anticipation, not just compliance. When the FDA required immunity to RFID readers before any standardized test method existed, Emitech had already developed a dedicated test bench that helped our clients secure their submissions. We are now applying the same forward-looking approach to 5G and Wi-Fi 6E/7.
- Unique technical capabilities for high-frequency near-field testing. Our antennas and generators cover frequencies up to approximately 40 GHz. For near-field testing above 18 GHz, we repurpose a high-precision motorized mast originally developed for radiofrequency measurements up to 140 GHz, ensuring homogeneous exposure and excellent reproducibility.
- An approach grounded in the FDA's risk management philosophy. The FDA does not systematically require additional testing: it wants to verify that the risk has been identified, analyzed and technically justified. Our experts help you build this demonstration — through testing or risk analysis, whichever is most relevant for your product.
- Support that reduces FDA supplemental information requests. By integrating these tests directly into our service offering whenever a client targets the US market, we reduce the risk of delays caused by an Additional Information Request during the 510(k) review process.
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Is your medical device ready for FDA clearance? Entrust us with your EMC testing and benefit from expertise that anticipates tomorrow's regulatory requirements — not just today's.
