Biomedical Safety Testing

All electrical appliances produced in the USA must follow the guide lines set forth & regulated by the government. This division is called the “National Electrical Code” (NEC). The NEC is a department under the regulatory division of the “National Fire Prevention Association” (NFPA).  The code or chapter which pertains to the medical industry is code 99 of the NFPA. All electrical appliances must be safe for use and the public can be assured of these units being designed, created and tested according to a division following the NEC called “Underwriters Laboratory” (UL).

In the case of Medical equipment the factory has to follow more stringent tests and and due to the NEC and a group named “Association for the Advancement of Medical instrumentation” (AAMI) this equipment needs to be tested on a regular basis after it is in use to see if it continues to meet the safety criteria set worth in code 99.

Electrical safety test includes the tests for ground integrity and can not be more than 500 miliohm and leakage current should not be more than 300 micro amp for sensitive equipment and 500 micro amp for general medical equipment

Along with the safety test some equipment must checked periodically for performance output such as defibrillators which we use a special wattage meter designed specifically for defibs to test the actual wattage output or joules delivered when the paddles are delivering a shock to a patient.

The EKGs are tested using a group of patterns to determine if it is picking up the correct signal so the physician, when reading your EKG, does not give you a misdiagnosis. Following is a very small list of items we test for output performance:

EKG

Defibrillators, AEDs

Patient monitors

Auto blood pressure units

Audiometers

Thermometers

Oxygen concentrators

Oxygen flow meters

Ultrasounds

vital signs monitors, spo2, respiratory HR, EKG wave

Patient warmers

IV pumps

Feed pumps

Electro surgical units

Autoclaves

Centrifuges, RPM

If after testing, the equipment is found to not be performing according to MFG specifications we can make the appropriate adjustments to put it into correct compliance.