IEC-62366-2 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

IEC-62366-2 - EDITION 1.0 - CURRENT


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IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.
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Document Number

IEC/TR 62366-2 Ed. 1.0 en:2016

Revision Level

EDITION 1.0

Status

Current

Publication Date

April 28, 2016

Committee Number

62A