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FDA Requiring RFID Immunity

The FDA has recognized the AIM 7351731 RFID Immunity testing as part of 510K/PMA submissions. This standard addressed the rise in RFID tags and readers used in medical facilities for tracking pharmaceuticals and medical supplies and has the following requirements;

As an alternative to this, the FDA is accepting the IEC 60601-1-2:2020 (edition 4.1) table 11 test in lieu of AIM 7351731 to address the RFID immunity requirements. The latest edition of the IEC 60601-1-2:2020 has the following requirements;

The latest medical collateral EMC standard IEC 60601-1-2:2020is a recognized consensus standard by the FDA. For Europe, the EN version has a dop date of 2021-09-19 and a dow date of 2024-03-19 allowing for a 3 year transition time before mandatory adoption.

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