Hello Mike
The Co-existence standard is both a test of immunity and influence with from and on many different emitter types. It really ALSO applies if you have a Radiofrequency type emitter in your product (e.g., Bluetooth or other wirekess transmission)..
The EMC standard (4th edition) itself will not necessarily handle what FDA wants to know about RF transmitters, though your co-existing testing will be similar to that updated EMC standard, you will be testing with different emitter types . I would suggest you discuss this with someone like UL or Intertek. UL passed me through to Garrett Industries for testing, coordinated through UL's Northbrook IL office.
I would be sure you stay involved with how your co-existence protocol and report are written and be involved in the approval of both since they will be similar but not the same as EMC. I did not recommend combining the two tests at the time in one protocol in case either objective failed, the whole plan would fail.
Good luck!
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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: 04-Feb-2019 04:16
From: Mike Kilkelly
Subject: EMC testing - IEC 60601-1-2 4th Edition and ANSI C63.27-2017
ANSI C63.27-2017 "... Evaluation Of Wireless Coexistence" is on the FDA list of recognized consensus standards since Aug 2017 yet test lab we use for IEC 60601-1-2 do not seem to regularly test to this standard.
Does anyone know if this standard is required by the FDA for 510k submissions as the 4th edition of IEC 60601-1-2 already covers testing for Proximity to wireless transmitters?
I would be grateful for any help or comments.
regards
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
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