Airborne Medical Equipment EMI/EMC

[Eng8492]

If the intended use of me equipment includes aviation or vehicle transport (as well as Home and Professional) , IEC 60601-1-2 4th Edition clearly states that EMI/EMC standards applicable to these modes of transport SHALL apply.
See Table 2 note D (page 26) and para 8.1.


For instance, DO-160G gives emissions limits and immunity levels for civil aircraft. And there are various specifications for boats and wheeled vehicles.

1) I am having trouble with the usual bureaucrats getting a copy of this standard--does anybody have a feel for how CISPR 11 Class A and B correspond to limits in DO-160G?

2) If DO-160G applies, isn't necessary to use DO-160G Tests and methods to determine emission levels/immunity levels rather that CISPR/61000 series methods?

 

[Pads38]

My understanding is that if your device includes use in an aircraft it will need to satisfy BOTH the 60601-1-2 tests and the aircraft tests.

It really is the case that you are best of working closely with your chosen EMC test house to define your test plan. Remember that the test plan has to be in place and agreed before any testing can take place.

Welcome to the forums.

 

[3dBUnderThe Limit]

There are no references in DO-160-G (EUROCAE ED-14G) to CISPR or the 61000 series test methods.

The tests in DO-160-G (EUROCAE ED-14G) are different from what we perform according to 60601-1-2. Check with your EMC test lab if they can perform the test or guide you to a test lab that can.


On the bright side only the emission part of Section 21 of DO-160G is applicable, there are a lot of nasty test cases in the rest of that document (unless your risk analaysis says otherwise)

 

[yodon]

I don't know if this is applicable but I have a client whose device will be in use during air transport (e.g., between battlefield and hospital). They indicated they would be required to comply with JECETS (https://www.wpafb.af.mil/Portals/60.../AFD-160512-024.pdf?ver=2016-09-22-072647-890). More than just EMI.

 

[3dBUnderThe Limit]

JECETS seems to be the US Army/Airforce equivalent of IEC 60601-1-12 (Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment)



In this case I would evaluate if 60601-1-12 is applicable for the device, as Yodun said: it's more than EMI.

 

[arodenhouse]

I am in a similar situation as the OP. We plan to comply with 60601-1-12 as well as EN 13718-1 (Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances). EN 13718-1 requires compliance with Section 20 (EMC) of DO-160G but does not specify a Category to used for testing. Has anyone had experience with the EMC testing according to DO-160G?