Immunity to RFID frequencies for Medical Devices

In 2018, the FDA (Food and Drug Administration) identified a non-compliance with the international standard IEC 60 601-1-2 on the basic safety and essential performance of electromedical devices and systems with regards to RFID systems.

Pointing to the lack of immunity of some medical devices (MD) to RFID systems increasingly implemented in the hospital environment, the FDA requires the application of the American standard AIM 7351731.

As a reminder, RFID (Radio Frequency IDentification) systems allow the exchange of information without contact (data, identification, etc.).

Used in addition to the IEC 60 601-1-2 standard which sets immunity requirements in the frequency range from 150kHz to 6GHz, the AIM 7351731 standard describes complementary tests of immunity to magnetic and electrical fields with modulations representative of the different RFID protocoles:

• 65 A/m at 134,2 kHz (ISO 14223)
• 7,5 A/m at 13,56 MHz (ISO/IEC 14443-3 for Type A, ISO/IEC 14443-4 for Type B)
• 5 A/m at 13,56 MHz (ISO/IEC 15693 and ISO 18000-3 Mode 1)
• 12 A/m at 13,56 MHz (ISO 18000-3 Mode 3)
• 3 V/m at 433 MHz (ISO/IEC 18000-7 )
• 54 V/m at 860-960 MHz (ISO/IEC 18000-63)
• 54 V/m at 2,45 GHz (ISO/IEC 18000-4) 

Risk management is at the heart of medical device safety assessment and a manufacturer is required to perform an assessment based on the requirements of the standard in combination with the risk identified by the manufacturer. It would not be useless for any electromedical product that could be exposed to RFID to include these tests for immunity to specific frequencies and modulations in its assessment.

Since September 2018, Emitech offers you the implementation of the specific tests of AIM 7351731 and can, on your request, carry them out under accreditation.

For more information, please do not hesitate to contact Yvon Leborgne (y.leborgne@emitech.fr)