DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-11
; VDE 0750-1-11:2016-04
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 60601-1-11:2015); German version EN 60601-1-11:2015
Medizinische elektrische Geräte - Teil 1-11: Besondere 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 60601-1-11:2015); Deutsche Fassung EN 60601-1-11:2015
Overview
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.
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
