AS IEC 60601.1.12:2017 applies to the Basic Safety and Essential Performance of Medical Electronic Equipment (MEE) and Medical Electronic Systems (MES), hereafter referred to as MEE Equipment and MESS Systems, intended for use in the Emergency Medical Services (EMS) 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 MEE Equipment and MESS 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. MEE Equipment and MESS Systems are often not solely intended for one environment. Such MEE Equipment or MESS Systems 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: MEE Equipment or MESS Systems intended for both the EMS environment and the professional healthcare facility environment.
NOTE 2: The EMS environment, MEE Equipment, and MESS Systems can be used in locations with unreliable electrical sources and outdoor environmental conditions.
