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EN60601-1-2 4th edition requirements - Tests for devices produced in two options
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EN60601-1-2 4th edition requirements - Tests for devices produced in two options
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  Post Number #1  
Old 10th August 2018, 07:02 AM
medical_electronic

 
 
Total Posts: 2
Please Help! EN60601-1-2 4th edition requirements - Tests for devices produced in two options

Hello, I am new here but I am little confused how should I testing devices in my company to get agree with new standard. For Example I need to prepare tests for device which is produced in two options:
with internal power supply 120V/60Hz
with internal power supply 230V/50Hz.
The power suplies are mounted differently, depending on the order. The rating voltage (sticker on the device) is also different for both types of power supply.

How should I perform EMC test to be agree with EN60601-1-2 4th edition?
In the standard there is a record that during testing it is enough to use "any voltage" and "any frequency". Can I, however, treat my bed as one device or as a completely different two devices?
If as two, could I do some tests together?
Maybe could I choose a worse case on the basis of pre-complenice test and test one device on this basis?
Thanks for comments.

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  Post Number #2  
Old 10th August 2018, 09:30 AM
Pads38

 
 
Total Posts: 767
Re: EN60601-1-2 4th edition requirements - Tests for devices produced in two options

As you have suggested Table 1 in the 4th edition clarifies supply requirements. As bullet point a) says, when it says 'Any one voltage' it is not necessary to re-test at additional voltages.

But if your 230V and 115V psu are totally different your test house may look to repeat some tests - perhaps at an exploratory level to check that they do not perform differently.

Welcome to the forums!
Thanks to Pads38 for your informative Post and/or Attachment!
  Post Number #3  
Old 14th August 2018, 03:54 AM
medical_electronic

 
 
Total Posts: 2
Re: EN60601-1-2 4th edition requirements - Tests for devices produced in two options

As you said, but as I understand it is in my interest to determine the methodology of measurement. The laboratory performs only tests according to my guidelines, which I determined based on the standard.
  Post Number #4  
Old 15th August 2018, 04:04 AM
3dBUnderThe Limit

 
 
Total Posts: 19
Re: EN60601-1-2 4th edition requirements - Tests for devices produced in two options

My two cents
As emission test shall be performed in the modes that maximizes emission, pre-compliance testing can guide you to the modes and configurations that you will test at the test lab. (ed4 7.2.1)

For the power supply, voltage should be any voltage within the rated range (Table 1 note a)).



So the method I would propose would be pre-compliance testing with both mains voltages. Based on that and design differences between the two configuration I would decide if final tests should be performed on both configurations or only one.
  Post Number #5  
Old 15th August 2018, 05:05 AM
MedMartin

 
 
Total Posts: 32
Re: EN60601-1-2 4th edition requirements - Tests for devices produced in two options

Hello,

In one project we evaluated a second source display and performed just preliminary EMC tests on the second display to evaluate possible differences for radiation and susceptility. This was fine for the test house and for the notified body.

The standard is not clear on this in your case and you should talk with your notified body. I would say that at least you have to document that there are no differences based on extensive preliminary testing in all modes (radiated and conducted emissions, immunitiy).
But maybe just perform the tests with all 2 configurations.

Best regards
Martin
  Post Number #6  
Old 17th August 2018, 10:47 AM
cdewitt

 
 
Total Posts: 22
Re: EN60601-1-2 4th edition requirements - Tests for devices produced in two options

In my experience if you have a single wide input range supply you test at the voltage that give a worst case response but if there are two different supplies you essentially have two different products since the EMC characteristics of each will be different. Some tests like conducted emissions or immunity, EFT on signal lines could be done on one or the other but anything that involves the power line needs to be done with both. This includes conducted and radiated emissions, conducted and radiated immunity, surge, EFT, ESD, Voltage Dip/Interruption.
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