There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.
Publication of IEC 60601-1, 3rd ed. Amendment 1 Imminent
It has been a bit more than 4 years since the A1 project was approved and initiated. The vote on Amendment 1 (A1) of IEC 60601-1, third edition project ended on 2 July 2012 and it was a resounding unanimous positive
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
Industry Update Amendment 1 of…
Industry Update Amendment 1 of IEC 60601-1:2005 is at the 1st committee draft stage and the estimated pub date June 2012 http://ow.ly/1nuKP