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Our Essential Performance Guidance Updated

posted May 2, 2018, 9:21 AM by Frank O'Brien   [ updated Sep 10, 2018, 2:12 AM ]
ep template
After many more years applying the Essential Performance (EP) and Basic Safety (BS) requirements, we've updated our guidance on EP and BS.  We've added new sections of how the Risk Managment process documents EP (and BS), EP Alarms, the EP (and BS) Verification Test Plan, and Examples covering a wide cross section of medical equipment.  The Test Plan section includes comments on IEC 60601-1-2:2014, the EM Distubance standard, and the lack of the Single Fault Condition exclusion. We've updated the sections on definitions, a template for EP, and the EP process flow chart.  You can access the updated EP guidance here.