Results 2 found
February 10th, 2016
Korea MFDS announces transition dates for IEC 60601 3rd ed. with Am. 1

On  December 31, 2015 the Korea Ministry of Food and Drug Safety (MFDS) issued Notification No. 2015-115 announcing its revision to the medical device regulations  for the transition to IEC 60601-1 Third Edition with Amendment 1.  According to UL’s regulatory experts in Korea, this regulation includes a total of 9 annexes and merges 7 kinds of international standards: Annex 1: IEC 60601-1:2012,… read more

September 17th, 2015
Health Canada recognizes IEC 60601 3rd edition with Amendment 1

According to the Health Canada website, effective August 31st, 2015, Health Canada now recognizes both IEC 60601 3rd edition (ed.3.0) and 3rd edition with Amendment 1 (ed.3.1). The equivalent Canadian National Standard CAN/CSA-C22.2 NO. 60601-1:14 is also on the recognized standards list under “Electromedical.” This means that medical device manufacturers looking to sell their products… read more