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AAMI/IEC 62366-1:2015
Medical devices - Application of usability Engineering to medical devicesMore info
This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering or usability engineering) process assesses and mitigates 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.
| Author | ANSI/AAMI/IEC |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2015-02-23 |
| ICS | 11.040.01 : Medical equipment in general |
| Replace | ANSI/AAMI/IEC 62366 (2007) |
| Cross references | IEC 62366-1 (2015-02), IDT |
| Year | 2015 |
| Document history | ANSI/AAMI/IEC 62366-1 (2015) |
| Country | USA |
| Keyword | ANSI 62366;ANSI/AAMI/IEC 62366;62366;ANSI/AAMI/IEC 62366-1-2015 |