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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > IEC 60601 - Medical Electrical Equipment Safety Standards Series
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How to fulfill IEC 60601-1-2 EMC Testing Requirements


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emc (electromagnetic compatibility), iec 60601 - medical electrical equipment
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  Post Number #1  
Old 26th September 2013, 05:00 AM
tallu

 
 
Total Posts: 48
Please Help! How to fulfill IEC 60601-1-2 EMC Testing Requirements

Hi Cove Members,

I need some opinions for accomplishing EMC tests.

Here is the brief description of the possible situation:
Your medical device System (consist of main unit and additional units) is EMC tested. You are going to release new unit which is part of the system and it's used with main unit.

Dilemma is that, is it acceptable to perform EMC test only for the new unit? Is there requirement(s) to perform EMC test for the whole system which consists main unit and this new unit?

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  Post Number #2  
Old 27th September 2013, 04:54 AM
tallu

 
 
Total Posts: 48
Re: How to fulfill IEC 60601-1-2 EMC Testing Requirements

Any thoughts?
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  Post Number #3  
Old 27th September 2013, 05:16 AM
Pads38

 
 
Total Posts: 534
Re: How to fulfill IEC 60601-1-2 EMC Testing Requirements

I would suggest that you discuss the situation with your EMC test house. If you can get them to agree that the changes are very unlikely to influence the EMC behaviour then that may be enough.

What may be possible is to agree, with the test house, that only certain parts of the test programme need to be repeated. So, if you look through your test results and find that, say, the radiated RF immunity was OK but nearly caused problems at 2GHz, horizontal polarization, then just repeat that part of the tests.

How successful this approach would be is somewhat dependent upon how constructively helpful your test house is. They are, naturally, rather conservative but if the approach throughout is one of constructive problem solving (rather than box ticking) can be very helpful.
Thanks to Pads38 for your informative Post and/or Attachment!
  Post Number #4  
Old 27th September 2013, 06:19 AM
tallu

 
 
Total Posts: 48
Re: How to fulfill IEC 60601-1-2 EMC Testing Requirements

Good point. I had similar point of view.

But it might be easier to test whole system. Feels like it makes device registration and approval processes more clear.

You dont have to combine information between two different EMC Test Reports and explain the relations etc.
  Post Number #5  
Old 27th September 2013, 06:58 AM
katapult

 
 
Total Posts: 7
Re: How to fulfill IEC 60601-1-2 EMC Testing Requirements

Hi Tallu,

I'd suggest to test the whole system in combination with the new part. In general you have to prove the combinability of the new part with the system. So why not check EMC too? If you don't check EMC with the system, you're going to have to explain your testing for every auditor again and again.
  Post Number #6  
Old 2nd October 2013, 01:31 AM
tomshoup

 
 
Total Posts: 9
Re: How to fulfill IEC 60601-1-2 EMC Testing Requirements

The device is the main unit plus whatever "other units" are specified to connect to the main unit. If the new accessory unit is intended to work with the main unit, then the device (main + accessories) has to be tested. Also, if the new accessory unit is expected to work with other generations of main unit or other generations of accessories, then you really should test all combinations. It comes down to what is the device, it's the main unit + accessory units, and that is what has to pass EMC.
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