DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-6
; VDE 0750-1-6:2016-02
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013); German version EN 60601-1-6:2010 + A1:2015
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Gebrauchstauglichkeit (IEC 60601-1-6:2010 + A1:2013); Deutsche Fassung EN 60601-1-6:2010 + A1:2015
Overview
IEC 60601-1:2005 is currently being amended to adapt this standard to the new state of the art. The use of this amendment means that the collateral standards to the IEC 60601-1 family shall also be formally adapted. This collateral standard specifies requirements for a process to be carried out by the manufacturer for the analysis, development and design, verification and validation of usability, insofar as usability affects the basic safety and essential performance characteristics of medical electrical equipment. Medical electrical equipment is referred to as ME equipment. The committee responsible for this standard is Subcommittee UK 811.4 "Ergonomics, usability, instructions of use" 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/UK 811.4 - Ergonomie, Gebrauchstauglichkeit, Gebrauchsanweisung
