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Evaluation of Basic Safety during EMC Immunity or Climate Testing

Benjamin Weber

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#1
Dear all,

basic safety and essential perfomance have to be evaluated during EMC and for example climate testing of 60601-1-11 /-12.

While essential perfomance is usually quite straight forward (e.g. clearly defined in a particular standard), I sometime struggle with basic safety in this situations.

If the device is not very complex and basic safety depends only on electrical safety and the corresponding insulation requirements (e.g. solid insulation of the enclosure and maybe clearances and distances on an internal PCB, maybe a DC-DC converter, digital isolator or optocoupler on the PCB). If the risk analysis and engineering judgement come to the conclusion that EMC testing will not influence any of the said aspects, do you think EMC immunity testing can be omitted?

I have sometime the same problem with climate testing of 60601-1-11 /-12 (Environmental conditions of transport/storage, continuous operating conditions....). If risk analysis and engineering judgement result is, that environmental conditions do not adversely affect basic safety, can this be omitted? In 60601-1-11 for most of the climate tests leakage current and dielectric strength testing is explicitly not required. But what, if nothing is left for evaluatin of basic safety, except maybe a visual inspection?

I would be happy to hear your oppinion on this. Do you have any experiences when EMC and/or climate testing was reduced? Did notified bodies or other authorities make any statements?

Kind regards,
Benjamin
 
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