This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th.  Please come and join in the audio conference.  Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rdedition questions that apply to the MDD and AIMDD.  Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^stedition.  This is a must read article for any electrical medical device manufacturer.  Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play.  One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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