There’s a regulatory update – which went relatively unnoticed given the historical period – that Notified Bodies are focusing on during technical file analyses.
It’s the 4.1 edition of the EN 60601-1-2 General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
The EN 60601-1-2/A1:2021, which is the correct way to cite it, contains updates impacting type tests, and for this reason, its implementation could require repeating or performing new tests.
The standard is not harmonized and has not been published in the Official Journal, but it certainly represents the state-of-the-art regulations in the EU. For this reason, it is advisable to apply it immediately to medical devices undergoing initial certification. Conversely, for products already compliant with edition 4.0 that are transitioning to MDR, it’s worth considering developing a rationale to postpone the execution of tests to a later stage. Preferably after harmonization has occurred.
The main changes concern:
- Revision of the table identifying at which voltages and frequencies to perform tests, for devices where the manufacturer identifies multiple supply voltages and/or frequencies.
- Update of Table 9 indicating the immunity test values for wireless RF communication systems for external access ports.
- Immunity tests that consider the possibility of having a medical device directly exposed (<15cm) to an interference source in the frequency range from 9 KHz to 13.56 MHz. These sources can be:
- Induction cooking hobs and ovens in domestic environments;
- RFID transponders and readers, for example:
- For the identification of surgical instruments;
- Systems to prevent swabs, sponges, or other materials from remaining in the patient after surgical procedures;
- Position detection devices (e.g., in catheter laboratories); etc.
- New approach possibilities for testing large devices that cannot be entirely positioned inside a classic semi-anechoic chamber.
- Complete revision of Annex F, dedicated to the interaction of this standard with the risk management document: greater precision is required in defining the reduction means applied to manage risks related to emission or immunity to electromagnetic fields.
Each situation, also depending on the reference Notified Body, requires an independent and dedicated assessment. We are available to help manufacturers determine the impact of this amendment on their medical device.
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