PD IEC/TR 80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices. Step-by-step risk management of medical IT-networks. Practical applications and examples | Status: Current

1 Scope This technical report provides step-by-step information to aid responsible organizations in implementation of the risk management process required by IEC 80001-1. Specifically, it details the steps involved in executing subclause 4.4 of IEC 80001-1:2010 and provides guidance in the form of a study of risk management terms, risk management steps, an explanation of each step, step-by-step examples, templates, and lists of hazards and causes to consider. The steps outlined within this technical report are considered to be universally applicable. Application of these steps can be scaled as described within this document.