Full Description

This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, developand evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITYENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assessand 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

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus