Eisner Safety Consultants

The old UL standards for Medical Devices & X-ray devices have been withdrawn as of December 21, 2009
Yes, it is true these old standards finally have been withdrawn.  UL’s announcement on December 21, 2009 stated “UL announces the withdrawal of the seventh edition of the Standard for X-Ray Equipment, UL 187, and the fourth edition [...]

ESC Newsletter #3 – Just Released
This issue we are going to focus on the 60601-1 series of standards based on the 3rd 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 [...]

FX Conferences Audio Conference on How to Mark & Label Devices Under IEC60601-1 3rd Edition presented by Leo Eisner
Audio Conference is on Wednesday Nov. 18, 2009, 1:00pm – 2:00pm Eastern Time, 60 minutes

Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX [...]

CENELEC FAQ’s page on the EN60601-1 Series of Standards in Relation to the MDD and AIMDD
CENELEC has issued a FAQs page on their website to clarify many of the confusing issues surrounding the EN60601 series of standards including the general (or base standard EN60601-1), the collateral standards (e.g. EN60601-1-XX), and the particular standards (e.g. EN60601-2-XX). [...]

ESC Newsletter #1 – Just Released
This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ‘09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct [...]