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The Risk Management of Medical Devices Regarding Electromagnetic Disturbances

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The Risk Management of Medical Devices Regarding Electromagnetic Disturbances

A previous version was published by In Compliance Magazine, February 2017 Edition, pages 32-42, www.incompliancemag.com

The risk management requirements of EN/IEC/ANSI/AMIEE 60601-1-2 Edition 3 (2007) and IEC 60601-1-2 Edition 4 (2014) are mostly either ignored or misunderstood by manufacturers, their EMC test labs, and medical regulatory assessors (other than in Germany). This article describes what they are, and a practical method for complying with them to make medical devices, equipment and systems safe enough as regards the consequences of electromagnetic interference (EMI).

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