On June 1, 2012 Japan issued their national version of IEC 60601-1:2005 (or 3rd ed.). The transition period has started as of June 1, 2012 but I am still determining what products under Japan’s MHLW’s (Ministry of Health, Labour
Update on National Implementations of IEC 60601-1:2005
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
DRAFT results implementation of 3Ed (EN60601 series) for CE marking
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