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
Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC 60601-1 & related 60601 Series of Stds
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
NB-MED issues V1.1 FAQ on Implementation of EN60601-1:2006 w.r.t. MDD
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
Two Conf’s on 60601 Series of Stds Mar 3 & 4th
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
Conf. on IEC 60601-1-11 & Proposed IEC 60601-1-12 (Home Health Care & Emerg Med Srvcs Environ Stds)
Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively Presenter: Leo Eisner of Eisner Safety Consultants When: March