Tag Archives: ANSI/AAMI ES60601-1
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
OSHA Close to Authorizing NRTL Certification to ANSI/AAMI ES60601-1 for Medical Equipment
After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program. In March 2014, OSHA announced... Read More