This is the second edition of CAN/CSA-Z17510-1, Sleep apnea breathing therapy - Part 1: Sleep apnea breathing therapy equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 17510-1 (second edition, 2007-10-01). It supersedes the previous edition, published in 2003 as CAN/CSA-Z17510-1 (adopted ISO 17510-1:2002).
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment (add at the end of the Subclause 1.1):
This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.
This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates.
Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.
This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:
- ISO 10651-2:2004;
- ISO 10651-3:1997;
- ISO 10651-4:2002;
- ISO 10651-5:2006;
- ISO 10651-6:2004.
This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12.
ISO 17510 covers sleep apnea breathing therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnea breathing therapy equipment to the patient. See also Figure AA.1.