What Does IEC 80001-1 Mean to You? an In-Depth Look at the Major Components and Objectives of This Critical Standard and Their Importance to You

In November 2010 we introduced, without any depth, the new international consensus standard, "IEC 80001-1 Ed.1: Application of Risk Management for IT-Networks Incorporating Medical Devices--Part 1: Roles, Responsibilities, and Activities." We briefly mentioned four aspects of 80001 that are communicated unambiguously when managing risk for a medical IT network: * The three risk components to be managed, in order of priority, are safety, effectiveness, and security.