BOXBOROUGH, MA, September 19-Intertek, provider of testing, inspection and certification, has announced two new white papers to help medical device manufacturers better understand the changes to IEC 60601-1, the international standard for the basic safety and performance of medical electrical equipment.
“IEC 60601-1: Changes from 2nd to 3rd Edition” provides a clause-by-clause overview of the specific changes to the standard’s requirements, as well as the latest acceptance status of the 3rd edition in major global markets.
“Essential Performance and Risk Management for the IEC 60601 Series” delves deeper in to the “new philosophy” of the 3rd edition, and reviews the information a test laboratory may expect from the device manufacturer to fulfill the new risk management requirements.
“In many cases, the changes in the 3rd Edition require a whole new way of thinking about product safety compliance,” says Bob Burek, Intertek medical technical manager. “Any one change to IEC 60601-1, when taken by itself, is enough of a problem to cause costly delays in getting your device to market. But when taken together, the new risk analysis and essential performance requirements can spell disaster if one is not aware of how to address them.” To download these two whitepapers, visit www.intertek-etlsemko.com/60601papers