The scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.
This European Standard specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions. Jet and very high frequency ventilation and oscillation are not considered in this part of the European Standard.
This European standard does not apply to devices covered by the scope of the EN 794 series. Masks and application accessories are adressed in Part 2 of this Standard (in preparation).
This European Standard does not cover external body ventilators as defined in EN ISO 4135.