EN 62366:2008

Medical devices - Application of usability engineering to medical devices

Publication date:   Sep 5, 2008

General information

99.60 Withdrawal effective   Mar 31, 2018

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical equipment

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Scope

Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems 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. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 62366:2008
99.60 Withdrawal effective
Mar 31, 2018

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 62366:2008/A1:2015

REVISED BY

PUBLISHED
EN 62366-1:2015