DIN EN ISO 17510-1:2008 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007); German version EN ISO 17510-1:2007
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 apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks
and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also
Figure AA. 1.
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 apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks
and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also
Figure AA. 1.
DIN EN ISO 17510-1:2008 history
2009DIN EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007); English version of DIN EN ISO 17510-1:2009-07
2008DIN EN ISO 17510-1:2008 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007); German version EN ISO 17510-1:2007