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BS EN 62366-1:2015+A1:2020

Medical devices-Application of usability engineering to medical devices

standard by British-Adopted European Standard , 08/19/2020

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Full Description

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 FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with NORMAL USE, i.e., CORRECT USE and USE ERROR. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

Incorporates the following:
BS EN 62366-1:2015

Product Details

Published:: 08/19/2020
ISBN(s):: 9780580981647
Number of Pages:: 60
File Size:: 1 file , 2.8 MB
Product Code(s):: 30359003, 30359003, 30359003
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