DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-11
; VDE 0750-1-11:2011-03
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010); German version EN 60601-1-11:2010
Medizinische elektrische Geräte - Teil 1-11: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung (IEC 60601-1-11:2010); Deutsche Fassung EN 60601-1-11:2010
Overview
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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/K 811 - Allgemeine Bestimmungen für elektrische Einrichtungen in medizinischer Anwendung
