Need to repeat IEC 60601-1-2 test agains ed3.0

[tallu]

My know-how doesn't cover next question and point of view, so, again I'm asking some advices =)

If your company have device which is tested according to IEC 60601-1-2 ed1.0 (long time ago), is it necessary or do we have make new set of test according IEC 60601-1-2 ed3.0?

There have not been any design changes which would impact to electrical safety of the device after EMC test was passed.

 

[Pads38]

I had a similar problem. However, I was able to put together a table that compared the tests of the earlier standard with those of the present standard. Using that I was able to show that the actual test requirements were largely unchanged. Test numbering has changed to align with Ed 3 of the base standard but that, for the large part, has not changed test requirements.

There was an additional requirement for, if I remember correctly, flicker. But I was able to include engineering justification as to how that would be very very unlikely to be a problem, along with a statement that it would be tested for that when we next visited the EMC test house. This approach was accepted by our auditor for more than 1 product.

 

[tallu]

Thanks Pads.

Could you share your comparison table?

 

[Pads38]

The table is device specific. In fact, the way I did it, there are 2 tables; one for emissions and one for immunity.

They simply listed each requirement along with the clause numbers from the 2 different editions of the standard, the "levels" applied and highlighted any changes.

So, for example, comparing EN versions 2001 and 2007, the Immunity test for ESD gives us:

Test: ESD
2001: Clause 36.202.2
2007: Clause 6.2.2

Levels
2001: 2,4,8kV Air discharge; 2,4,6kV contact
2007: Identical

Method
2001: IEC 61000-4-2
2007: Identical

It is also worth highlighting how the 'Compliance Criteria' would be unaffected by the revision of the standard.