Power supplies meet latest IEC60601-1 3rd edition medical standards
07 July 2013
Effective from June 30 2013, the US FDA no longer accepts references to 60601 2nd Edition in any submissions.
Sponsors or manufacturers pursuing FDA for approval of electrical medical devices will need to show compliance to ES60601-1 3rd edition.
Excelsys Technologies has successfully had its Xgen range of configurable power supplies approved to IEC 60601-1:2005 3rd Edition. This is in addition to the existing approval to the 2nd Edition and ensures full medical approval is maintained during the transition period from 2nd to 3rd editions.
The updated medical approvals for the Excelsys Xgen family includes ANSI/AAMI ES60601-1:2005, Medical electrical equipment– Part 1, General requirements for basic safety and essential performance, CAN/CSA-C22.2 No. 60601-1:08 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, IEC60601-1:2005 Medical electrical equipment– Part 1: General requirements for basic safety and essential performance.
Excelsys medical product offering includes four-slot configurable power supplies, ranging in power-levels from 200-750W, and 6 slot power supplies, ranging in power from 400W-1450W. DC output voltages are available in user selectable combinations from 1.0V to 58V, each is fully isolated with individual output adjustment.
Common specifications include leakage current <300uA, 4KV Isolation and efficiency up to 90 percent. Optional specifications include low acoustic noise and low leakage current (below 150µA)
A universal 85-264VAC input range is standard as is over voltage protection and the full load operating temperature range is from -20 to +70°C.
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