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IEC 60601-1 3rd Edition Leakage Current Differences The approval of IEC60601-1 3rd Edition will introduce several changes to the safety regulations for medical devices, starting with a change in titles from the 2nd Edition: IEC60601-1 2nd Edition: “Medical Electrical Equipment – General requirements for safety” to the 3rd Edition: IEC60601-1 3rd Edition: “Medical Electrical Equipment – General requirements for basic safety and essential performance”.
This document will cover requirements for hazards, marking and documentation, as well as other topics that will impact the way medical devices are evaluated for compliance. One area in Electrical Hazards is Leakage Current. While almost everything has remained the same from 2nd to 3rd Edition in terms of leakage current testing, there are some changes for medical device designers, evaluators, and manufacturers to be aware of.
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