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Standard [WITHDRAWN]

DIN EN 62366:2016-05

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

German title
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366:2007 + A1:2014); Deutsche Fassung EN 62366:2008 + A1:2015
Publication date
2016-05
Original language
German
Pages
125

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Publication date
2016-05
Original language
German
Pages
125

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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.

Replacement amendments

This document replaces DIN EN 62366:2008-09; VDE 0750-241:2008-09 .

This document has been replaced by: DIN EN 62366-1:2017-07; VDE 0750-241-1:2017-07 .

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