DIN EN 60601-1-8:2014-04

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. 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. The second edition of IEC 60601-1-8 was published in 2005. Since its publication, issues have been identified with respect to pulse and burst testing. In addition, issues have been raised by IEC/62D/MT 22, "Electromedical diagnostic and patient monitoring equipment", during implementation of alarm system requirements in particular standards within their scope of work. This supplement shall enable improved application of various medical electrical equipment. The responsible committee is DKE/K 811 "Allgemeine Bestimmungen für elektrische Einrichtungen in medizinischer Anwendung" ("Common aspects of electrical equipment used in medical practice") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.