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IEC/TR 62366-2:2016

(Main)

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

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

General Information

Status
Published
Publication Date
27-Apr-2016
ICS
11.040.01 - Medical equipment in general
Technical Committee
ISO/TC 210 - Quality management and corresponding general aspects for medical devices
Drafting Committee
ISO/TC 210/JWG 3 - Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability
Parallel Committee
IEC/SC 62A - Common aspects of electrical equipment used in medical practice
Current Stage
Ref Project

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IEC/TR 62366-2:2016 - Medical devices
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IEC TR 62366-2

Edition 1.0 2016-04

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

---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC TR 62366-2


Edition 1.0 2016-04




TECHNICAL



REPORT









colour

inside










Medical devices –

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



























INTERNATIONAL

ELECTROTECHNICAL


COMMISSION





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



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

---------------------- Page: 3 ----------------------
– 2 – IEC TR 62366-2:2016 © IEC 2016
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
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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