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DIN IEC/TR 80001-2-5 VDE 0756-2-5:2016-03

* German Language Version *

Application of risk management for IT-networks incorporating medical devices

Part 2-5: Application guidance – Guidance on distributed alarm systems

(IEC/TR 80001-2-5:2014)
Class/Status: Standard, valid
Released: 2016-03
VDE Art. No.: 0700940

Contents

Surveys of healthcare personnel have indicated significant discontent with alarm signals. Problems include difficulty in identifying the source of an alarm signals, loud and distracting alarm signals, and the high incidence of false positive or negative alarm conditions.
Surveys of manufacturers of medical monitors demonstrated a wide variety of default alarm presets. The leading reason for disabling aralm signals is the large number of alarm signals associated with false positive alarm conditions.
Safety of patients depends on the ability of the operator to correctly discern the characteristics of alarm signals. Usability is an important element in the design of alarm signals that are readily discernible without being unnecessarily distracting or disturbing. This approach is intended to rationalize the current situation, to reduce confusion by limiting proliferation of alarm signals and their control states, and to minimize distraction for other people.