Hi All,
Standard IEC 60601-1-11 states that medical electrical equipment used in the home care environment, if it is not permanently installed, will need to be a class II electrical device. Does this mean that a class I electrical device can no longer be called medical electrical equipment if it is to be used in a home?
As 60601-1-11 is not mandatory, if a manufacturer of a class I electrical device chooses not to test their product to it, do they need to test it to something else to enable it to be used in the home?
In my opinion, if this standard states that the medical electrical equipment for use in the home cannot be class I electrical, surely the standard should be mandatory or this requirement appear in something that is?
Your help as ever will be much appreciated.
Jo
Standard IEC 60601-1-11 states that medical electrical equipment used in the home care environment, if it is not permanently installed, will need to be a class II electrical device. Does this mean that a class I electrical device can no longer be called medical electrical equipment if it is to be used in a home?
As 60601-1-11 is not mandatory, if a manufacturer of a class I electrical device chooses not to test their product to it, do they need to test it to something else to enable it to be used in the home?
In my opinion, if this standard states that the medical electrical equipment for use in the home cannot be class I electrical, surely the standard should be mandatory or this requirement appear in something that is?
Your help as ever will be much appreciated.
Jo
Last edited: