DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-1-6
; VDE 0750-1-6:2010-10
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010); German version EN 60601-1-6:2010
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Gebrauchstauglichkeit (IEC 60601-1-6:2010); Deutsche Fassung EN 60601-1-6:2010
Overview
This Collateral Standard specifies the requirements for a process to be carried out by a manufacturer in order to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. Medical electrical equipment is hereafter 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
