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IEC 60601-1-2 EMC Tables

MikeKilkelly

Starting to get Involved
#1
It is my understanding that the IEC 60601-1-2 - 3rd edition requirement to have EMC tables in the Instruction manual is not a requirement for the 4th Edition of IEC 60601-1-2

Is there any requirement then to supply these EMC tables for product sold in the U.S?

regards
Mike
 
#2
Hi Mike,

You are right to say that there is no absolute requirement to include the tables that were introduced by IEC 60601-1-2:2001 and retained by the 2007 edition.
However, clause 5.2.2.1 demands that the 'Technical Description' includes
a) compliance for each part of the tests
b) any deviations
c) all necessary instructions...

I have found that the easiest way to satisfy these requirements is to include the information... in a set of tables! - I have retained the existing tables as the least effort to comply.
 

Kuldeep Singh

Involved In Discussions
#4
Hi Everyone,

We are manufacture of Class II medical Device. Can anyone tell me about the "Immunity to proximity fields from RF Wireless communications equipment" under Cl. 8.10 of IEC 60601-1-2:2014.

Is it applicable to all medical devices ?
or
applicable only to those products having some wireless communications?

Your help will be appreciated and thanks in advance.
 
#5
It is applicable to all devices.

There is such a proliferation now of mobile phones, pagers, walkie-talkies, wifi routers etc etc that medical devices can be expected to be exposed to that these tests become necessary.

And remember, this list is just a suggested minimum test requirement - depending on your device and it's proposed use scenario, you may have to do further tests or use higher levels than in the table.
 

Kuldeep Singh

Involved In Discussions
#6
Thanks Pads38 , Our devices are mostly used in Controlled environment like ICU, Operation theaters where Mobile phones are prohibited, secondly a warning for not using RF wired and wireless communication outlined in IFU. Can we justify this for non performing this test. Although our machine is tested as per IEC 61000-4-3 upto 2.7GHz.

Otherwise we have to send our all the machine to external lab for this test if there is any lab having feasibility upto 5.7GHz frequency range.
 

Jaydub

Involved In Discussions
#7
Any EMC test lab with IEC 60601-1-2 in their scope would be capable of performing this test. In addition to mobile phones, it also covers WiFi, Bluetooth etc. It might be one of those cases where it is easier to do the test than to explain why you didn't.
 
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