Does IEC 60601-2-49 apply to Thoracic Bioimpedance?

[craiglab]

IEC 60601-2-49 Ed. 2.0 b:2011 has in the description “The scope of this standard is restricted to medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part.”

The device we are considering is similar to thoracic bioimpedance where you have 2 patient auxiliary circuits and 4+ monitoring leads. It is not clear if the auxiliary circuits and monitoring are each considered as seperate applied parts, and if this standard applies.

 

[Peter Selvey]

Is the equipment intended to generate alarms? I don't have the 2011 edition yet, but the older edition (2001) only applies if there are alarms.

To understand any scope statement, always read the definitions used in the scope statement (and in some cases the definitions used in those definitions).

An "alarm" is not fully defined but normally means at least medium or high priority alarms as per IEC 60601-1-8, i.e. not just a message.

If there are alarms, then it seems the standard is intended to apply when there are at least two different functions that can trigger an alarm (e.g. one from ECG, one from SpO2). If the patient connections are all related to the same "function", then the standard would not apply (keep in mind though, IEC 60601-1-8 still applies).

 

[raymond02302]

As you described, I imagine that the equipment is just for thoracic bioimpedance. the 2 patient auxiliary circuit and 4 monitoring leads are all for this clinical use. 1 circuit and 2 leads are used to generate the HF current and the other circuit and leads are for measuring the impedance.
If so, IEC 60601-2-49 is not applicable, as the euipment is just one applied part and only one physiological monitoring unit.