Heads Up! – Updated 24 May 2021
Written by Bill Hardin and Leo Eisner
Thx for all the great support from the LinkedIn, RAPS Forum, the standards and test lab communities that have provided feedback on this post. Turns out with all the good feedback we got from these communities we need to update this post as CISPR 11 Group 2 intentional radiators was included in the previous edition but you really need to be aware of RFID requirements.
The FDA has been insisting that medical device, IVD and even implanted medical device manufacturers meet AIM 7351731 RFID immunity testing as part of their 510k/PMA submissions. This test is onerous since it includes RF immunity at levels of up to 54V/m, nearly twice the field strength (28V/m) that the IEC 60601-1-2 table 9 requires, and would often result in design changes to increase RF immunity.
From AIM 7351731:
IEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11 – RFID requirements based on AIM 7351731 standard values) that they want manufacturers to do before submitting. The FDA has been accepting the IEC 60601-1-2:2020 table 11 test in lieu of AIM 7351731 testing, which is very good news as there are only two AIM 7351731 frequencies to be tested instead of all the test frequencies and test levels of Table 3 of the AIM 7351731 standard.
“IEC 60601-1-2:2020 (ed. 4.1 ) – Table 11 contains RFID requirements, FDA is accepting this in lieu of all the AIM 7351731 testing – This is good news“
This 2020 version of IEC 60601-1-2 is still about three years out from taking effect in EU (with no grandfathering allowed) unless your Notified Body may expect ‘State of the Art’ in a shorter time period (some do require this) or your company will go with ‘State of the Art’ which is a requirement of the EU MDR 2017/745 Annex I, Items 1 & 4, and per MDCG 2021-5, but FDA went first by Recognizing the standard at the end of 2020.
This blog previously erroneously stated that CISPR 11 Group 2 radiated emission limits had changed as part of the transition to IEC 60601-1-2:2020. They have not changed. So no redesign is needed for that but you still may need to redesign your product based on the RFID requirements.
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