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/AMD1:2006
IEC 60825-2:2004
IEC 60601-1-11:2015
IEC 60601-1:2005
ISO 14937:2009
IEC 60601-1-12:2014
IEC 60601-1-8:2006/AMD1:2012
IEC 60068-2-27:2008+AMD1:2013
ISO 7010
ISO 7000
IEC 60529:2013
IEC 60417
IEC 60601-1-8:2006
ISO 15223-1:2016
IEC 60825-2:2004/AMD2:2010
IEC 60601-1:2005/AMD1:2012
IEC 62366-1:2015
IEC 60601-1-6:2010
IEC 60068-2-64:2008
IEC 60068-2-27:2008
ISO 4135:2001
ISO 3744:2010
IEC 60825-1:2014
IEC 60601-1-2:2014
ISO 14155:2011
IEC 60601-1-6:2010/AMD1:2013
IEC 60068-2-31:2008
ISO 9000:2015
ISO 3534-2:2006
IEC TR 60878:2015
IEC 60601-1-3:2008/AMD1:2013
IEC TR 60721-4-7:2001
IEC 62366:2007/AMD1:2014
IEC 60601-1-3:2008
ISO 13732-1:2006
ISO/IEC Guide 99:2007
IEC 60601-1-10:2007
ISO 80601-2-61:2011
ISO 16142-1:2016
IEC 62366:2007
IEC TR 60721-4-7:2001/AMD1:2003
ASTM E456 - 13AE3
ISO 11073-10404:2010
IEC 60721-3-7:2002
CLSI C46-A2:2009
GUM:1995
ASTM F2761-14
VIM
CLSI/NCCLS H1-A3:2000
ISO/IEC Guide 98-3:2008


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