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 equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

Sleep apnoea breathing 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.

Cross References:
IEC 60601-1:2005/AMD1:2012
ISO 14937:2009
ISO 23328-2:2002
IEC 60601-1:2005
ISO 10993-1:2009
ISO 80601-2-70:2015
ISO 17664:2004
ISO 4135:2001
ISO 5356-1:2015
ISO 15223-1:2012
ISO 23328-1:2003
ISO 5356-2:2012
ISO 4871:1996
IEC 61672-1:2013
ISO 3744:2010
ISO 18562-1
ISO 17510-1:2007
ISO/TR 16142:2006
ISO 17510-2:2007
ASTM F1246 - 91(2005)
ISO 14971:2007
AAMI TIR12:1994 (R96)


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