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

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Abstract

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.

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Additional information

Publication typeTechnical Report
Publication date2012-07-10
Edition1.0
Available language(s)English
TC/SCTC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss
ICS11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Stability date  2024
Pages66
File size1586 KB

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