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

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.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons
35	INFORMATION TECHNOLOGY. OFFICE MACHINES
35.020	Information technology (IT) in general
35.080	Software. Programms
35.100	Open systems interconnection (OSI)
35.110	Networking
35.160	Microprocessor systems
35.200	Interface and interconnection equipment
35.240	Applications of information technology
35.260	Office machines

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