Eisner Safety Consultants

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 [...]

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

BS EN 60601-1-11:2010 Medical electrical equipment-Collateral standard for use in home healthcare environ Pub 31-JUL-10 http://ht.ly/2fRwW

Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/