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Publication detail

 
Reference IEC 62366 ed1.0 withdrawn corrigendum
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Title Medical devices - Application of usability engineering to medical devices
Publication date 2007-10-18
Format, price
(Swiss francs)
and language
300.- 209 pages
300.- 2333 Kb
 
Abstract 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.
Technical Committee 62A - Common aspects of electrical equipment used in medical practice  RSS
ICS Codes
11.040 Medical equipment
 
Replaced by
Stability date 2014
 
Work in progress
ProjectStage codeForecast publication date
No project under development--


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