Leaders in High Efficiency, High Reliability Power Supplies
Find a local partner| Consult an engineer | Contact Excelsys          excelsys google plus excelsys linkedin excelsys facebook

Menu

Excelsys Xgen Configurable Power Supplies meet latest, FDA Required IEC60601-1 3rd Edition Medical Standards

 
Medical Image

Effective from June 30th 2013 the US FDA will no longer accept 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.  This is an across-the-board requirement for all aligned and Recognised Collaterals and Particular standards.  

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.ns. Sponsors or manufacturers pursuing FDA for approval of electrical medical devices will need to show compliance to ES60601-1 3rd edition. This is an across-the-board requirement for all aligned and Recognised Collaterals and Particular standards.

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 4 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%. 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.

Dermot Flynn, European Sales Director of Excelsys Technologies, comments, “ Excelsys is committed to ensuring that our products adhere to and are certified to the latest safety standards which is vital to provide support to our medical customer base and to continue our growth in this important market. Excelsys aim to ensure all of their products are future-proof to give designers and buyers the maximum confidence in their products.”

Excelsys medically approved power supplies offer market leading power densities in a very small package size, with the added bonus of being totally user configurable. Typical applications for the medical approved Excelsys Xgen range include clinical diagnostic systems, medical imaging equipment, dialysis systems and medical lasers. The Xgen series of medical power supplies simplify system design without compromise.

To learn more about these new standards and to view the official FDA notice follow the following link : http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=30508.

Website Search

CoolX Modular Power Supply

Category

catalogue