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

This technical report is a step-by-step guide for the application of practical risk management when creating or changing a medical IT network. It provides simple processes, examples, and information to assist the identification and control of risks.

The document is intended for use in conjunction with the requirements set out in IEC 80001-1:2010. All relevant requirements in IEC 80001-1 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).

Main sections:

· Scope

· Normative references

· Terms and definitions

· Prerequisites

· Study of terms used in risk management

· The steps

· IEC 80001-1:2010, Subclause 4.4: Step by step

· Practical examples