New EMC standard IEC 60601-1-2:2014

[Pads38]

I recently noticed that IEC have published a new version of the EMC standard IEC 60601-1-2:2014.

Has anyone had a chance to examine it yet?
Are there any new things that will trap the unwary?

From the preview that is available on the IEC web store site it seems that it is actually shorter than the 2007 version that it replaces! Not often that happens.

 

[SteveK]

Re: New EMC standard 60601-1-2:2014

Hi Pads,

The Standard itself summarises the most significant changes, to paraphrase so as not to breach copyright (noting EM stuff is far from my comfort zone):

• It now specifies immunity test levels wrt intended use environments i.e. home healthcare (IEC 60601-1-11) and special environments.

• Specifications of tests and test levels to improve MEE and MES when portable RF equipment is used closer than previous.

• Specifications of immunity tests and immunity test levels (ITL) according to ports of MEE and MES.

• Higher immunity test levels based on the maximum level of EM disturbances where actually used.

• Better harmonisation with risk concepts of basic safety and EP including deleting the term “life supporting”.

With the additions of:

• Guidance on ITL for special environments.

• Guidance on the adjustment of ITL wrt intended use.

• Guidance on risk management for basic safety and EP wrt EM disturbances.

• Guidance on immunity pass/fail criteria.

I hope this helps

Steve

 

[Pads38]

Re: New EMC standard 60601-1-2:2014

Thanks Steve.

It looks like the daft declaration tables have gone (I hope).

I hope also that the new guidance on Essential Performance and Pass/Fail criteria for the Immunity tests is clearer (and not too draconian!)

 

[thesmyle]

Re: New EMC standard 60601-1-2:2014

Hi guys,

If we already have complied to of IEC 60601-1-2 3rd edition and have already declared our product (declaration of conformity) how does the 4th edition affect us? I'm guessing at the moment it does not affect us at all (according to FDA and Office Journal).

When the new standard is adopted, will we have to re certify to the 4th edition? My guess for EU is that we will have to re certify. For USA I'm guessing maybe transition period involved like that they did with IEC 60601-1 2nd and 3rd edition.

Thank you for the help.

-Mark

 

[Pads38]

Re: New EMC standard 60601-1-2:2014

Hi Mark,

We still have some products for which the EMC test report shows that the standard used was 60601-1-2:2002 - ie the second edition. This was picked up by our Notified Body.

What we did was to produce a side-by-side comparison table between edition 2 and edition 3 (the 2002 version vs. 2007). Using this we could show that there were no significant changes for our products. The NB has accepted this approach.

If I remember correctly, the 2007 version added voltage fluctuation and flicker tests. But our devices are small and low powered (<100W) so we argued that the likelihood of any problems with that test were very small, and we would conduct that test when we were next visiting our EMC test house. Again, this argument was accepted.

I have yet to see the details of Edition 4 but expect that this approach will still be possible for some years yet.

 

[thesmyle]

A test that stood out for me was the ESD portion where it was increased from 6kv/8kv to 8kv/15kv (contact/air). I don't think there's a way to confidently justify that the system will survive. I did see several posting about what you were doing (a comparison) and I it worked out but for this 3rd to 4th it may not work out?

maybe we'll actually see something in the magnetic field test now that it went from 3 to 30A/m