ISO 17510-1:2002

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.