BS EN ISO 80601-2-61:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for
use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE,
including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.Cross References:IEC 60825-2:2004/AMD1:2006IEC 60825-2:2004IEC 60601-1-11:2015IEC 60601-1:2005ISO 14937:2009IEC 60601-1-12:2014IEC 60601-1-8:2006/AMD1:2012IEC 60068-2-27:2008+AMD1:2013ISO 7010ISO 7000IEC 60529:2013IEC 60417IEC 60601-1-8:2006ISO 15223-1:2016IEC 60825-2:2004/AMD2:2010IEC 60601-1:2005/AMD1:2012IEC 62366-1:2015IEC 60601-1-6:2010IEC 60068-2-64:2008IEC 60068-2-27:2008ISO 4135:2001ISO 3744:2010IEC 60825-1:2014IEC 60601-1-2:2014ISO 14155:2011IEC 60601-1-6:2010/AMD1:2013IEC 60068-2-31:2008ISO 9000:2015ISO 3534-2:2006IEC TR 60878:2015IEC 60601-1-3:2008/AMD1:2013IEC TR 60721-4-7:2001IEC 62366:2007/AMD1:2014IEC 60601-1-3:2008ISO 13732-1:2006ISO/IEC Guide 99:2007IEC 60601-1-10:2007ISO 80601-2-61:2011ISO 16142-1:2016IEC 62366:2007IEC TR 60721-4-7:2001/AMD1:2003ASTM E456 - 13AE3ISO 11073-10404:2010IEC 60721-3-7:2002CLSI C46-A2:2009GUM:1995ASTM F2761-14VIMCLSI/NCCLS H1-A3:2000ISO/IEC Guide 98-3:2008All current amendments available at time of purchase are included with the purchase of this document.