Cover IEC TR 80001-2-1:2012
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IEC TR 80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples

Circulation Date: 2012-07
Edition: 1.0
Language: EN - english
Seitenzahl: 66 VDE Artno.: 218982

Content

IEC/TR 80001-2-1:2012(E), which is a technical report, 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 (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. 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. They can never be the first step, as risk management follows the general process model which sets planning before any action.