Tag Archives: EN 60601-1:2006/A1:2013

IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets

The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world.  IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries.  Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO... Read More