Eisner Safety Consultants

A New Work Item Proposal for Medical Electrical Equipment & Medical Electrical Systems used in the Emergency Medical Services Environment will be submitted to ISO by the end of November 2010.  This proposed standard follows the structure of the Collateral Standard IEC 60601-1-11 Medical Equipment and Medical Systems for Home Use that was published April 2010. [...]

The QuadTech 5th Edition Electrical Safety Testing Guide is a useful document to help you understand the basics of Leakage Current and Dielectric Tests for 60601-1 and for additional standards.  This document is a useful resource for understanding some of the basics of electrical safety testing.  To obtain this document click here.

Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010.  As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings that will help medical device manufacturer’s better understand the coming & current standards requirements.  We [...]

#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH

BS EN 60601-2-43:2010 Med. elec. equip. – Particular rqrts – X-ray equip. for interventional procedures Pub. 31-JUL-10 http://ht.ly/2fSOS