DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-8
; VDE 0750-1-8:2014-04
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 60601-1-8:2006 + A1:2012); German version EN 60601-1-8:2007 + Cor.:2010 + A1:2013
Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen (IEC 60601-1-8:2006 + A1:2012); Deutsche Fassung EN 60601-1-8:2007 + Cor.:2010 + A1:2013
Overview
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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/K 811 - Allgemeine Bestimmungen für elektrische Einrichtungen in medizinischer Anwendung
Responsible international committee
ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
