Eisner Safety Consultants

This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition.  It is the top article on our Featured Articles WebPage.  This article is on the National Implementations of IEC 60601-1:2005 for the EU under the MDD & AIMDD, Canada under the purview of [...]

Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS OF THE IEC 60601 FAMILY OF STANDARDS ON HEALTH CANADA’S LIST OF RECOGNIZED STANDARDS.”  HC has [...]

6 Feb 2012 – The NB-MED EN60601-1:2006 issues team released their first official version (V1.1) of this important implementation document in regards to EN 60601-1 with respect to the Medical Device Directive 93/42/EEC (primarily written for this directive) and also the Active Implantable Medical Device Directive 90/385/EC (refer to Q & A 3.3.1).  This project [...]

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 [...]

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 [...]