Results 4 found
November 12th, 2015
ANVISA new rule requires IEC 60601 with Amendment 1

On September 25, 2015, the Brazil National Health Surveillance Agency (ANVISA) issued a new rule IN 4, 2015-09-24, (that supersedes the IN 11, 2014-12-16) and which require the IEC 60601-1 Ed. 3.1 (3rd edition with Amendment 1) mandatory for any new products seeking ANVISA approval.  For all projects started and quotes accepted after September 25,… 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

April 13th, 2015
Clearing up the confusion around 60601-1 Amendment 1 and Risk Management

There continues to be confusion over expectations for manufacturers implementing a risk management process to satisfy IEC 60601-1 and Amendment 1.  Unfortunately, because the 60601 Standard is a type test standard, and necessarily eliminated reference to Clause 9 in ISO 14971 on Post-Production Information, some manufacturers have interpreted this to mean that they need not… read more

February 21st, 2014
FDA Extends 3rd Edition Transition date to 2016

The FDA has indicated a revision to the transition date for 3rd edition plus amendment 1. FDA will accept declarations of conformity, in support of premarket submission to ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 until August 1, 2016. After that date FDA will be looking for declarations of conformity to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012… read more