DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-2-31
; VDE 0750-2-31:2012-04
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source (IEC 60601-2-31:2008 + A1:2011); German version EN 60601-2-31:2008 + A1:2011
Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit interner Stromversorgung (IEC 60601-2-31:2008 + A1:2011); Deutsche Fassung EN 60601-2-31:2008 + A1:2011
Overview
This product standard of the DIN EN 60601-1 (VDE 0750-1) standard series describes the safety requirements for external cardiac pacemakers powered by an internal electrical power source and to patient cables. Basically, cardiac pacemakers treat cardiac arrhythmias. Such arrhythmias reduce cardiac output and can lead to confusion, dizziness, loss of consciousness and death. The objective of pacing is to restore cardiac rhythm and output appropriate to the patient's physiological needs. With respect to the 2009-11 version, the comments received during the harmonizing process in Europe have been included in this standard. Several references to defined terms that were not printed in small caps as well as the terminology usage have been revised. The responsible committee is Joint Subcommittee GUK 812.5 "Aktiv betriebene Implantate" ("Active implantable medical devices") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
