SS IEC 62366-1 (+A1):2018
Medical devices – Part 1 : Application of usability engineering to medical devices
OVERVIEW
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.
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 62 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 62366-1 : 2015 IDT |