The FDA has established compliance criteria for electromagnetic compatibility that now includes protection against exposure to RFID devices. This recent requirement is related to potential risks due to the increase of RFID equipped devices to a level that the FDA has determined warrants inclusion on current FDA applications. AIM 7351731, an FDA recognized standard for the healthcare industry, has been established to determine safe limits for medical devices with respect to RFID exposure.
RFID protection compliance testing is over and above testing requirements found in the IEC 60601-1-2, and is being mandated by the FDA on their most recent acceptance criteria for medical devices and equipment.
D.L.S. Electronic Systems has developed a streamlined program that supports formal compliance testing for medical devices and equipment when exposed to electromagnetic phenomena related specifically to RFID enabled devices, as required by the FDA.
D.L.S. engineering staff offers specialized guidance on the testing of non-implantable medical devices to determine if they are immune to emissions from radio frequency identification (RFID) systems. Test protocols are included for the major commercial implementations of RFID as standardized by ISO, including LF, HF, and UHF RFID. Both active and passive ISO RFID standards are covered. The D.L.S. program provided addresses all medical devices and how to test for immunity to emissions from RFID systems.
To learn more about the new immunity to RFID requirements established by the FDA and required for future medical products contact D.L.S. today at 847-537-6400 or go to www.dlsemc.com/RFID.