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IEC/TR 62366-2:2016

Medical devices — Part 2: Guidance on the application of usability engineering to medical devices IEC/TR 62366-2:2016

Publication date:   Apr 28, 2016

General information

90.92 Standard to be revised   Jan 15, 2024

IEC

ISO/TC 210 Quality management and corresponding general aspects for medical devices

Technical Report

11.040.01   Medical equipment in general

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Scope

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.

Life cycle

NOW

PUBLISHED
IEC/TR 62366-2:2016
90.92 Standard to be revised
Jan 15, 2024

REVISED BY

IN_DEVELOPMENT
IEC/CD TS 62366-2