CUI Inc’s range of medical power supplies has received IEC 60601-1 3rd edition medical safety certifications. The certification covers 17 product families ranging from 15 W to 400 W, helping to ease compliance for medical device engineers.
IEC 60601-1 is the internationally harmonised safety standard for electro-medical equipment and 3rd edition revisions came into effect in the US on July 1st for equipment introduced after this date. The US’s ANSI/AAMI ES60601-1:2005 implementation follows Canada’s CAN/CSA C22.2 No. 601.1 and the EU’s EN60601-1:2006 implementations of the 3rd edition revisions. CUI’s medical power supplies are now approved to meet both the European and US standards.
IEC 60601-1 3rd edition changes the way a medical device is classified. The medical device manufacturer uses an ISO-14971 risk analysis and management process to define 1 of 4 possible MOP (means of protection) classifications. ISO-14971 also specifies a process to identify hazards associated with medical devices; used to evaluate associated risks, control these risks, and monitor the effectiveness of the controls.
CUI’s medical power supply family is designed to offer two MOPPs (means of patient protection), providing engineers with an easier path to achieve IEC 60601-1 3rd edition compliance for their end product.