scope:

This International Standard applies to MASKS and their ACCESSORIES used to connect SLEEP APNOEA BREATHING THERAPY EQUIPMENT to the PATIENT. It specifies requirements for MASKS and ACCESSORIES, including any connecting element, that are required to connect the PATIENT-CONNECTION PORT of SLEEP APNOEA BREATHING THERAPY EQIPMENT to a PATIENT for the application of sleep apnoea breathing therapy (e.g. nasal MASKS, EXHAUST PORTS and HEADGEAR).

SLEEP APNOEA BREATHIG THERAPY EQUIPMENT is covered by ISO 80601-2-70. Figure A.1 shows the typical elements of this International Standard together with the SLEEP APNOEA BREATHING THERAPY EQUIPMENT of ISO 80601-2-70 that form a sleep apnoea breathing system.

This International Standard does not cover ORAL APPLIANCES.