DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-12
; VDE 0750-1-12:2016-01
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (IEC 60601-1-12:2014); German version EN 60601-1-12:2015
Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme in der Umgebung für den Notfalleinsatz (IEC 60601-1-12:2014); Deutsche Fassung EN 60601-1-12:2015
Overview
This collateral standard from the DIN EN 606060-1 (VDE 0750-1) series of standards describes the safety requirements for medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. These are often used in places with unreliable power sources and poor electrical grounding, as well as outdoors and during transport. For the purposes of this standard, the emergency medical services environment is treated as a supplement to the professional health care facility. The task of emergency services is either to provide treatment to persons in urgent need of medical care with the aim of satisfactorily treating the illness, or to provide timely transport of the PATIENT to the nearest clinical care facility. It is assumed that there are relatively few watercraft for emergency use worldwide compared to ambulances, rescue helicopters or air ambulances. Therefore this standard does not concern the requirements for ME equipment intended for use in watercraft for emergency use or in rail vehicles for emergency use. Manufacturers who intend to use ME equipment for use in watercraft or railway vehicles should use risk management to extend the requirements of this standard to cover these environments. The requirements of this standard have been developed with the participation of clinicians, engineers and regulators. The committee responsible 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
