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  • BSI
    BS EN 62366:2008 Medical devices. Application of usability engineering to medical devices
    Edition: 2008
    $500.90
    / user per year

Description of BS EN 62366:2008 2008

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.

Standard NumberBS EN 62366:2008
TitleMedical devices. Application of usability engineering to medical devices
StatusWithdrawn
Publication Date2008-04-30
Withdrawn Date2018-07-17
Replaced ByBS EN 62366:2008+A1:2015
Identical National Standard OfEN 62366:2008, IEC 62366:2007
DescriptorsMedical technology, Instructions for use, Medical equipment, Equipment safety, Hazards, Medical instruments, Design, Ergonomics
ICS11.040.01 Medical equipment in general
CommitteeCH/62/1
ISBN978 0 580 54371 5
PublisherBSI
Pages104

The following editions for this book are also available...

Format Year Publisher Type Title Annual Price
2015
BSI
Standards
 $569.50 Buy

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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