EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

Publication date:   Sep 16, 2015

General information

60.60 Standard published   Apr 24, 2015

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical equipment

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Scope

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 62366:2008/A1:2015

WITHDRAWN
EN 62366:2008

NOW

PUBLISHED
EN 62366-1:2015
60.60 Standard published
Apr 24, 2015

CORRIGENDA / AMENDMENTS

PUBLISHED
EN 62366-1:2015/A1:2020

PUBLISHED
EN 62366-1:2015/AC:2015

PUBLISHED
EN 62366-1:2015/AC:2016-09