TSE - TS EN 62366-1
Medical devices - Part 1: Application of usability engineering to medical devices
active
| Organization: | TSE |
| Publication Date: | 23 October 2015 |
| Status: | active |
| ICS Code (Medical equipment): | 11.040 |
scope:
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER toanalyse, specify, develop and evaluate the USABILITY of a MEDICALDEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMANFACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess andmitigate RISKS associated with CORRECT USE and USE ERRORS.
Document History
February 18, 2016
Medical devices - Part 1: Application of usability engineering to medical devices
A description is not available for this item.
TS EN 62366-1
October 23, 2015
Medical devices - Part 1: Application of usability engineering to medical devices
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER toanalyse, specify, develop and evaluate the USABILITY of a MEDICALDEVICE as it relates to SAFETY. This USABILITY ENGINEERING...