IEC TR 80001-2-1:2012

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Prerequisites
5 Study of terms used in RISK MANAGEMENT
6 The steps
7 IEC 80001-1:2010, Clause 4.4: Step by step
8 Practical examples
Annex A (informative) - Common HAZARDS,
        HAZARDOUS SITUATIONS, and causes to
        consider in MEDICAL IT-NETWORKS
Annex B (informative) - List of questions to consider
        when identifying HAZARDs of the MEDICAL IT-NETWORK
Annex C (informative) - Layers of MEDICAL IT-NETWORKS where
        errors can be found
Annex D (informative) - Probability, severity, and RISK
        acceptability scales used in the examples in this
        technical report
Annex E (informative) - MONITORING RISK mitigation
        effectiveness
Annex F (informative) - RISK ANALYZING small changes in a
        MEDICAL IT-NETWORK
Annex G (informative) - Example of Change Window Form
Annex H (informative) - Template for examples
Bibliography

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.