Eisner Safety Consultants

This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to [...]

Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards?  If you do, you have until June 30th, 2011 to submit your questions to an expert [...]

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th.  Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

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

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/