Introduction

The necessity to mitigate/eliminate leakage current stems from the need to reduce patient risk. Electrocution in the form of microshocks can have fatal consequences for the patient if the path of the electricity comes in line with the heart. 

Objectives 

The sole objective of this verification activity is to ensure that the risk of patient shock due to improper device function is at a minimum that is compliant with the standards set forth by the IEC (IEC 61557-16:2023).

Methods

Since there is no reliable way to measure at the resolution necessary for true adherence to the standard set forth by IEC (International Electrotechnical Commission) for leakage current in medical devices (500 microamps) without interference from 60 Hz powerline noise in the test setting, verification will involve adherence to proper electrical grounding and insulation techniques during the construction of the device. No further statistical analysis or measurements are necessary for this task.

Results

The device was determined to be compliant as the circuit for the control system as well as all other electronic components were assembled with proper grounding techniques as well as all loose wires were assembled in conduit to avoid interference from 60 Hz noise and shield the patient from any electricity.