This part of the 80601 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.

The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS.

NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT.

Cross References:
IEC 60601-2-2:2017
EN IEC 60601-2-2:2018
EN 60601-2-27:2014
EN 60529:1991
EN 60601-1:2006/A11:2011
IEC 60529:1989 Cons Ed 2-1
EN 60601-1-6:2010
IEC 60601-1-12:2014
EN 60601-1:2006/A12:2014
IEC 60601-1-6:2010
EN 60601-1-8:2007/A11:2017
EN 60601-1-2:2015
IEC 60601-1-2:2014
IEC 60601-1-11:2015
EN 60601-1:2006
IEC 60601-1:2005
EN 60601-2-34:2014
IEC 60601-2-27:2011
EN 60601-1-8:2007/corrigendum Mar. 2010
IEC 60601-2-34:2011
EN 60601-1-8:2007
IEC 60601-1-8:2006
EN 60601-1:2006/A1:2013
EN 60601-1:2006/corrigendum Mar. 2010
EN 62366-1:2015
IEC 62366-1:2015
IEC 60601-2-16
EN IEC 60601-2-16
EN ISO 80601-2-56
ISO 80601-2-72
EN ISO 80601-2-72
ISO 80601-2-56
ISO 80601-2-13
EN ISO 80601-2-13


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