DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 62366
; VDE 0750-241:2016-05
Medical devices - Application of usability engineering to medical devices (IEC 62366:2007 + A1:2014); German version EN 62366:2008 + A1:2015
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366:2007 + A1:2014); Deutsche Fassung EN 62366:2008 + A1:2015
Overview
This consolidated version includes a simplified procedure for assessing the suitability for use of medical devices that could not yet be developed according to the complete process of DIN EN 62366. This will enable manufacturers to make adjustments in a shorter period in order to meet regulatory requirements. The successor standard IEC 62366-1 will also include this simplification. 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
