Application of risk management for IT-networks incorporating medical devices – Part 2-3: Guidance for wireless networks

This technical report supports healthcare delivery organisations (HDOs) in risk management for medical IT networks that incorporate 1 or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner.

The intended audience is the HDO IT department, biomedical and clinical engineering departments, risk managers and the people responsible for design and operation of the wireless IT network.

Main sections:

· Scope and object

· Normative references

· Terms and definitions

· Wireless medical IT network: An introduction

· Wireless medical IT networks: Planning and design

· Wireless medical IT networks: Deployment and configuration

· Wireless medical IT networks: Management and support

· General risk control measures

· Annex A: Clinical use cases and network traffic profiles

· Annex B: Questions to consider