Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy devices
For ISO 17510-1:2002, the scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.
ISO 17510-1:2002 specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions.
ISO 17510-1:2002 is not applicable to jet and very high frequency ventilation and oscillation.
ISO 17510-1:2002 is not applicable to devices covered by the scope of the EN 794 series.
ISO 17510-1:2002 is not applicable to external body ventilators as defined in ISO 4135.
NOTE Masks and application accessories are addressed in ISO 17510-2.