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IEC 60601-1-8 Alarms Testing

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-8 Introduction:

Medical electrical equipment and medical electrical systems are increasingly used in medical practice. Alarm signals are frequently used to indicate unsatisfactory physiological patient states, unsatisfactory functional states of the medical electrical equipment or medical electrical system or to warn the operator of hazards to the patient or operator due to the medical electrical equipment or medical electrical system. Information signals convey information that is independent of an alarm condition.

Surveys of healthcare personnel have indicated significant discontent with alarm signals. Problems include difficulty in identifying the source of an alarm signal, loud and distracting alarm signals, and the high incidence of false positive or negative alarm conditions [16] 1). Surveys of manufacturers of medical monitors demonstrated a wide variety of default alarm presets. The leading reason for disabling alarm signals is the large number of alarm signals associated with false positive alarm conditions. See also bibliography.

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. IEC 60601-1-8 was developed with contributions from clinicians, engineers and applied psychologists.

The terminology, requirements, general recommendations and guidance of IEC 60601 1 8 and EN 60601 1 8 testing are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for particular standards.

The effectiveness of any alarm system depends critically on its implementation by the responsible organization. It is important that the responsible organization configure the alarm system so that an operator is not able to compromise it.

Keystone Compliance assists manufacturers with IEC 60601-1-8 and EN 60601-1-8 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-1-8 test lab needs.