IEC/TR 80001-2-1:2012(E) is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process.
Guide to Risk Management Standards for Medical IT-Networks
