Ginger,
Refer to the Draft Guidance EMC of Medical Devices (attached) dated Nov 17 2020. The AIM 7351731 is a Recognized Consensus Standard and is noted in Section J - focuses on RFID emitters. Also, of course, IEC 60601-1-2 is referenced many times throughout this document and is a Recognized Consensus Standard. Refer back to my 2nd comment in this thread as testing to the IEC 60601-1-2, ed. 4.1 for RFID requirements is a much better deal than testing to all the requirements under the AIM standard.
PS - I like to go by Leo. Only those that knew me back when I first started working at UL well over 30 years ago called me Leonard. Please call me Leo.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 25-May-2021 07:10
From: Ginger Cantor
Subject: IEC 60601-1-2:2020 (Ed 4.1) Hidden Surprise! - Heads Up!
Hi Leonard
Since when has FDA really been insisting on this? I have never come across it. Is it Office/Division specific? I actually have not had any questions from FDA on basic EMC standard, only on additional RF wireless testing requirements per the 2014 guidance.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 24-May-2021 19:02
From: Leonard Eisner
Subject: IEC 60601-1-2:2020 (Ed 4.1) Hidden Surprise! - Heads Up!
Really Important update to note - Updated 24 May 2021
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.
View the updated blog post for more details and all the updates at https://bit.ly/60601-1-2Ed4dot1HiddenSurprise.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
Original Message:
Sent: 21-May-2021 02:41
From: Leonard Eisner
Subject: IEC 60601-1-2:2020 (Ed 4.1) Hidden Surprise! - Heads Up!
IEC 60601-1-2:2014, 4th edition, references CISPR 11:2010 (a.k.a. EN 55011), had no radiated rf emissions requirements for group 2 devices (intentional radiators) between 150kHz and 30 MHz. This is the basis for all group 2 medical devices on the market today.
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 735131 standard values) that they want manufacturers to do immediately. In that 2020 standard, 60601-1-2 references CISPR 11:2015 + A1:2016 + A2:2019 version that inherits a new group 2 only RF radiated emissions test with limits that apply for 150kHz – 30 MHz. (See tables at the bottom of this post). Home healthcare devices must meet Group 2 class B, while hospital only devices may meet Group 2 class A.
That's not the end of the story
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
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