Eisner Safety Consultants

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

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Updated EN60601 Series FAQ Posted on Cenelec site in regard to the MDD & AIMD & EN60601 Series
The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC site

Updated EN60601 Series FAQ in regard to the MDD & AIMDDD to be posted on CENELEC website in the near future
The document is an update to the current posted document issued 9 October 2009 on the CENELEC site

In the April 2009 edition of our medical information flyer ‘Transition to EC Directive 2007/47/EC’, we informed you that we assumed, in view of the status of discussions at that time, that new declarations of conformity would have to be issued.
In our newsletter of 2 July 2009 we revised this statement and explained that not [...]

Time is running out to meet the MDD Amendment 2007/47/EC (Mar 21) see http://www.EisnerSafety.com/products/ for great resource at $249