Apatient monitoris an electronic medical device that consists of one of more monitoring sensors, a processing component(s), and a screen display (also called a “monitor”) that provide and record for medical professionals a patient’s medical vital signs (body temperature, blood pressure, pulse rate and respiratory rate) or measurements of the activity of various body organs such as ECG monitors, anesthesia monitors, or EKG monitors.
Scope: 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.
Main Tests as per Standards:
- Leakage Current
- Power Input
- Temperature test
- Environmental test
- High Voltage test
- Impulse test
- Mechanical tests