BS EN 60601-2-49:2015 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.

ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use.

The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART.

This standard does not specify requirements for individual monitoring functions such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.


Cross References:
IEC 60601-1-2:2007
EN 60601-1-2:2007
EN 60601-1-2:2007+corrigendum Mar.:2010
IEC 60601-1-8:2006
EN 60601-1-8:2007
EN 60601-1-8:2007+corrigendum Mar.:2010
ISO 15223-1:2007
IEC 60601-2-2:2009
EN 60601-2-2:2009
EN 60601-2-2:2009+A11:2011
IEC 60601-2-27:2011
EN 60601-2-27:2014
IEC 60601-2-34:2011
EN 60601-2-34:2014
ISO 80601-2-56
IEC 62366
EN 80601-2-56
EN 62366


Replaces BS EN 60601-2-49:2001 which remains current

All current amendments available at time of purchase are included with the purchase of this document.