EMC Test Report Requirements to IEC 60601-1-2:2009

[candymqa]

Hello,

I was recently audited by my notified body and they have question my EMC Test report to IEC 60601-1-2:2009............ Am I required to retest my instrument to the 3rd edition?

Please any assistance is greatly appreciated!!!!

 

[Ronen E]

Am I required to retest my instrument to the 3rd edition?

Yes you are.

 

[Pads38]

I am slightly confused here (that's not difficult!)

The third edition of 60601-1-2 is the 2007 edition, which remains the current edition listed in the OJ (with the 2010 amendment).

IEC have published 60601-1-2:2014, but it has yet to be recognised, and there will still be a transition period where the 2007 version will still be valid.

With the Annex Z fiasco it is taking a long time for new international standards to get onto the OJ, so I would expect the 2007 version to be around for some time yet.

I have previously had an NB question a report that listed a previous edition of 60601-1-2, so created a comparison table that mapped the test requirements across the versions and was able to show that, for our device, there were no additional requirements. This was accepted by the NB (more than once).

 

[candymqa]

I am slightly confused here (that's not difficult!)

The third edition of 60601-1-2 is the 2007 edition, which remains the current edition listed in the OJ (with the 2010 amendment).

IEC have published 60601-1-2:2014, but it has yet to be recognised, and there will still be a transition period where the 2007 version will still be valid.

With the Annex Z fiasco it is taking a long time for new international standards to get onto the OJ, so I would expect the 2007 version to be around for some time yet.

I have previously had an NB question a report that listed a previous edition of 60601-1-2, so created a comparison table that mapped the test requirements across the versions and was able to show that, for our device, there were no additional requirements. This was accepted by the NB (more than once).

Thanks Pads38 I am a little confused also! I was not with the company at the time the testing was completed. I am going by the test report in my technical file. " EUT demonstrates compliance with IEC 60601-1-2:2001-09. Radiated Emissions test CISPR 11, Electrostatic Discharge Immunity IEC 61000-4-2 and Radiated Immunity IEC 61000-4-3.
Does this mean retesting to IEC 60601-1-:2006+A11:2011 is needed.


Thanks for any reply!

 

[Pads38]

I successfully mapped between 60601-1-2:2001 and the 2006 version. I showed both that the methods of the applicable tests had not changed and that the test levels (the immunity test level) was unchanged as well.

I did find a couple of additional requirements (Flicker and harmonics IIRC) but was able to show that these would be highly unlikely to be an issue as my device was small and low powered. I also indicated that the additional testing would be added when we next visited the test house.