CEI - EN 62366-1/A1
Medical devices Part 1: Application of usability engineering to medical devices
active, Most Current
| Organization: | CEI |
| Publication Date: | 1 March 2021 |
| Status: | active |
| Page Count: | 28 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
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. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to HAZARDS including loss or degradation of clinical performance.
Document History
EN 62366-1/A1
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....
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...