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Bridgeport Magnetics Receives Medical Certification to IEC60601-1

September 02, 2013 by Jeff Shepard

Bridgeport Magnetics Group, Inc. is now certified in the third edition of the medical safety standard IEC60601.1 and its equivalent ANSI (UL), CSA and EN standard for its line of hospital grade isolation transformers. The ISO-PUCK is available up to 3000VA and its bare isolation transformers up to 6000VA. As of June 1, 2013 all new medical devices in the USA must be certified to the third edition of IEC60601.1 or its equivalent ANSI (UL) standard.

The ISO-PUCK transformers are supplied with a bracket for easy wall mounting next to a power outlet or onto a medical cart. They serve to guarantee that the leakage current from computers, printers or medical electronics cannot exceed the maximum allowed value even in the case of frayed and aging insulation in operating rooms and patient care areas. The certification also applies to its line of bare (non-enclosed) isolation transformers used by OEM manufacturers of medical devices.

To eliminate the risk of hazardous and life threatening leakage currents (also called touch current) , the medical safety standards limit the touch current to 100 micro amps with grounds lifted for fixed equipment. For portable equipment the current shall not exceed 500 micro amps with the ground wire disconnected. The main requirement in the third edition is the emphasis on the manufacturer to maintain a Risk Management File as specified in ISO14971 to ensure long term product reliability and safety.