SS IEC 62366-1:2018
Medical devices - Part 1 : Application of usability engineering to medical devices
OVERVIEW
Specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical devise 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.
COMMENTS
The International Electrotechnical Commission (IEC) has issued Amendment No. 1 to this standard. The following are available for purchase at the Singapore Standards e-Shop:
Amendment only (click here).
Standard incorporating the Amendment (click here).
PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 56 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 62366-1 : 2015 IDT |