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.
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.