DIN EN 60601-1-11:2011-03

This collateral standard applies for medical electrical equipment and medical electrical equipment used in the home healthcare environment and supplements DIN EN 60601-1 (VDE 0750-1):2007-07. It applies regardless of whether the medical electrical equipment is used by a lay operator or by trained healthcare personnel. Medical equipment intended solely for use by emergency medical devices or solely for use in professional healthcare facilities is not included in the scope. This collateral standard gives special guidance on how to take into account the potential lack of training of a lay operator and possibly those supervising the use of the medical electrical equipment or medical electrical systems. It has been developed with contributions from clinicians, engineers and regulators. The responsible Committee is K 811 "Allgemeine Bestimmungen für elektrische Einrichtungen in medizinischer Anwendung" ("General provisions for electrical equipment for medical application") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.