Thu, 01/26/2012 - 11:02
There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.
This article explains the philosophy behind the major…
Dale Hallerberg
Technical manager for medical product testing
Dale Hallerberg is the technical manager for medical product testing at TÜV Rheinland of North America. His bachelor of science in electrical engineering is from the University of Illinois. He has more than 25 years experience in product safety testing and electrical safety research. He is a member of the AAMI Electrical Section, and is active on the IECEE Risk Management Task Force. He is also part of the development team for the third edition amendment 1 of IEC 60601-1—“Medical equipment/medical electrical equipment—Part 1: General requirements for basic safety and essential performance,” published by the International Electrotechnical Commission (IEC).
Thu, 01/26/2012 - 11:02