Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

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.

Dispositifs médicaux — Partie 2: Titre manque

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IEC TR 62366-2

Edition 1.0 2016-04

Medical devices –
Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2:2016-04(en)

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IEC TR 62366-2

Edition 1.0 2016-04





Medical devices –

Part 2: Guidance on the application of usability engineering to medical devices




ICS 11.040.01 ISBN 978-2-8322-3346-7

  Warning! Make sure that you obtained this publication from an authorized distributor.

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– 2 – IEC TR 62366-2:2016 © IEC 2016
1 Scope and purpose . 9
1.1 Scope . 9
1.2 Purpose . 9
2 Normative references. 10
3 Terms and definitions . 11
4 Mapping between the requirements of IEC 62366-1 and the guidance of
IEC TR 62366-2 . 14
5 Background and justification of the USABILITY ENGINEERING program . 14
5.1 How SAFETY relates to USABILITY . 14
5.2 Reasons to invest in U

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