DIN EN 60601-1-11:2016-04

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use intended by their manufacturer, as specified in the instructions for use, in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This revision became necessary in order to adapt the supplementary standard to the structure and changes of the consolidated version DIN EN 60601-1/A1:2013. 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.