DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 62366-1
; VDE 0750-241-1:2017-07
Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015
Medizinprodukte - Teil 1: Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366-1:2015 + COR1:2016); Deutsche Fassung EN 62366-1:2015 + AC:2015
Overview
This standard is the second edition of IEC 62366. As of the second edition the IEC 62366 series is split into two documents: IEC 62366-1, which describes the process, and IEC 62366-2, which provides explanations for the usability process. This modification is intended to meet the demand of various regulators in the medical field that improved usability is becoming increasingly important in preventing errors in the medical treatment process. The integration of the usability engineering process has been supplemented by formative evaluation and summative evaluation. The committee responsible for this standard is DKE/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
