Results 4 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

March 12th, 2015
IEC issues 2nd edition of IEC 60601-1-11, Medical Equipment in the Home Healthcare environment

Earlier this year, the IEC finalized and published the latest edition of IEC 60601-1-11:2015, the Collateral standard for medical devices used in the Home Healthcare environments. Manufacturers of applicable devices need to consider the additional risks posed as more devices move to support patients and health outside of the clinical environment, including ease of use,… read more

December 1st, 2013
OSHA ready to recognize 3rd Edition

As of January 1, 2014, the U.S. FDA will require new electromedical device submissions via including 510(k) and PMA to demonstrate conformity to IEC 60601-1:2005 plus Amendment 1.   As of Nov. 25, 2013, OSHA has now indicated through a Federal Register notice that it intends to recognize ANSI AAMI ES 60601-1:2005 (3rd edition) for certified… read more