AAMI News: Jan 2013: Excellent Article on Amendment 1 (A1) to IEC 60601-1 Underscores Role of Safety in Device Design.
Two industry leaders in the development of IEC 60601-1, 3rd ed. A1 answer some really good questions such as: Why changes to Risk Management & Essential Performance, What else changed in the standard, and What makes A1 unique. This article is part of AAMINews letter for Jan 2013.
AAMINews on IEC60601-1 Amendment 1