NEN-EN-IEC 62366-1
Medical devices - Part 1: Application of usability engineering to medical devices
active
| Organization: | NEN |
| Publication Date: | 1 May 2015 |
| Status: | active |
| Page Count: | 123 |
| ICS Code (Medical equipment): | 11.040 |
scope:
NEN-EN-IEC 62366-1 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 CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
Document History
January 1, 2016
Medical devices - Part 1: Application of usability engineering to medical devices
A description is not available for this item.
NEN-EN-IEC 62366-1
May 1, 2015
Medical devices - Part 1: Application of usability engineering to medical devices
NEN-EN-IEC 62366-1 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...