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Scrip Regulatory Affairs Article on IEC 60601-1 for US & Canada

11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1” Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada.

To read this article please go to Featured Articles webpage. Thank you Scrip Regulatory Affairs for allowing us to post on our Featured Articles Page of our Website.  This is not for public distribution please refer your associates that you want to read the article directly to the Featured Articles webpage.

We are in the process of setting up a standards reconnaissance service where we monitor the MEDICAL ELECTRICAL EQUIPMENT and HOME USE MEDICAL ELECTRICAL standards of your choice.  If you are interested in this service please contact Leo Eisner at Leo at EisnerSafety dot com or 503-244-6151.  We would be happy to discuss what we can do for your organization as Leo is on many of the standards committees that these standards are involved with.  Below is a summary of my involvement in these committees.

Leo is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).  He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”.  Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)  To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).