Why do we Safety Test Medical Devices?

A safety test, with a certified electrical safety analyzer, is conducted on every device that enters the clinical envirionment in compliance with The Joint Commision, DNV, and the state's Department of Health. This ensures that the device poses no risk to both the patient and clinical user. Electrical resistance is measured (needs to fall below 0.5 ohms) to determine whether the integrity of the ground wire is stable enough to shunt any power safely into the AC outlet ground- protecting an indivdual in contact with the device. Leakage current is also measured and must fall below the determined 500mA value. This procedure is mandated by NFPA99 specifications to reduce the risk of patient and clinical user electrical hazards posed by todays various medical devices in both professional and home environments. Once a device has been approved for use, a sticker is placed on device to tell end-users its safe to use within the period determined, usually 12 months.