This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS, which are intended, as indicated in the instructions for use by
their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES
ENVIRONMENT), as defined in 3.1.
NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use.
The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that any other use outside the
MANUFACTURER’S INTENDED USE can result in a HAZARDOUS SITUATION for the PATIENT.
The EMS ENVIRONMENT includes
– responding to and providing life support at the scene of an emergency to a PATIENT
reported as experiencing injury or illness in a pre-hospital setting, and transporting the
PATIENT, while continuing such life support care, to an appropriate professional healthcare
facility for further care.
– providing monitoring, treatment or diagnosis during transport between professional
healthcare facilities.
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in
professional healthcare facilities covered by IEC 60601-1 without the additions of
IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely
intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple
use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within
the scope of this standard.
EXAMPLE ME EQUIPMENT or ME SYSTEM intended for both the EMS ENVIRONMENT and the professional healthcare
facility environment.
NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical
sources and outdoor environmental conditions.