Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance for distributed alarm systems

This technical report gives guidance and practical techniques for responsible organisations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems.

The report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from 1 or more sources to ensure safety and effectiveness.

Main sections:

· Scope

· Normative references

· Terms and definitions

· Functions of the distribution of alarm conditions

· Types of systems for distributing alarm conditions

· Risk management

· Annex A: Correspondence between the risk control measures of this technical report and IEC 60601-1-8

· Annex B: Types of sources

· Annex C: Applicability of types of system for the distribution of alarm conditions

· Annex D: Scalability of types of system for the distribution of alarm conditions