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CEI EN 62366-1

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

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Organization: CEI
Publication Date: 1 December 2018
Status: active
Page Count: 4
ICS Code (Medical equipment): 11.040

Document History

March 1, 2021
Medical devices Part 1: Application of usability engineering to medical devices
In the second sentence, replace “with CORRECT USE and USE ERRORS, i.e., NORMAL USE” with “with NORMAL USE, i.e., CORRECT USE and USE ERROR”. NOTE 1 SAFETY is freedom from unacceptable RISK....
CEI EN 62366-1
December 1, 2018
Medical devices Part 1: Application of usability engineering to medical devices
A description is not available for this item.
April 1, 2016
Medical devices Part 1: Application of usability engineering to medical devices
This part of IEC 62366 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...
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