Particular standards, essential performance in EMC Immunity Test

Eamon

Involved In Discussions
#1
I have a simple point to check about the interaction between particular standards and 60601-1-2 immunity testing.

When a particular standard specifies a minimum level for essential performance, is it simply the case that this essential performance requirement transfers into the requirements for immunity testing?

For example 60601-2-26:2012, 3ed (EEG) specifies (201.12.1.101.3) "The signal noise caused by the EEG amplifier and PATIENT CABLE shall not exceed 6µV peak-to-valley referenced to input (RTI)".

On one hand, these EP requirements specify test setups that are probably not compatible with, and certainly cannot all be simultaneously deployed within e.g. the specified RF EMF immunity test setup (-2-26 Figure 202.102).

On the other hand, IEC 60601-1-2 requires a test criterion of maintaining essential performance, and the particular standard sets minimum EP requirements.

Does this 6µV noise level specified as essential performance for EEG translate into a maximum RF EMF artefact level of 6µV in the EMC test? In this context, is the EMF artefact "caused by the EEG amplifier and patient cable"? It's certainly picked up by the cable, for the most part...

There might be other questions pertaining to other EMC immunity test setups, but perhaps someone can help me explore the principle of the matter, by starting with this one.
 
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Peter Selvey

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#3
Two aspects here:

In the general case, essential performance should be maintained in normal condition, and EMC immunity tests are in principle intended to represent the normal environment. So for example an NIBP should have ±3mmHg static pressure accuracy, it should maintain this through all the tests.

But there are always special cases. For example EEG might be performed in a location that has low EM noise for various reasons (screened room, and /or located away from transmission tower etc). These special cases can be documented in the RMF.

Second aspect is the 6µV limit specifically refers to the "signal noise caused by the EEG amplifier and PATIENT CABLE". So it could be argued that this is a requirement which is not affected by EM noise, except in the sense that the some EM fields might damage the device (e.g. ESD, high magnetic field?), in which case the requirement would be rechecked after the ESD test.

There are likely to be many items of essential performance which are not affected by environmental tests like EMC. The general standard (Clause 4.3) states that for essential performance, compliance is checked by inspection and if necessary functional tests. The "if necessary" parts allows for engineering judgement on a case by case basis.
 
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