Appareils électromédicaux – Partie 2-49 : Exigences particulières pour la sécurité de base et les performances essentielles des moniteurs patient multifonctions

201.1 Scope, object and related standards 

Clause 1 of the general standard1 applies, except as follows: 

201.1.1 * Scope 
Replacement: 

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. 

This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS 
such as ECG, invasive pressure and pulse oximetry. The particular standards related to these 
PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME 
EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards also apply. 

EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where 
ISO 80601-2-12 also applies. 

EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for 
dependent PATIENT where ISO 80601-2-72 also applies. 

EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where 
ISO 80601-2-13 also applies. 

EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 
60601-2-16 also applies. 

This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.