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Testing & Standards For An Evolving Medical Device Landscape

An Overview Of The 4th Edition Of IEC 60601-1-2 Medical Device EMC Standard

The dynamics of the global healthcare industry are changing. Rapid market level growth is being complemented by trends which are evolving the face of medical electrical (ME) devices. Portability, for instance, is a defining characteristic of this new era of medical devices. Portable medical devices are noted to be worth $20 Billion USD by 2018.1 As the world becomes more connected, medical devices are moving out of hospitals and into homes and other environments. These environments often have a reduced capability to control electromagnetics as well as reduced levels of medical supervision.

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