At a glance
- Short name
- IEC 62366
- Jurisdiction
- US
- Also known as / related labels
- IEC 62366-1:2015 · ISO 14971 · FDA HFE Guidance · IEC 62366-2 (guidance)
What this entry covers
Evaluate medical device usability engineering per IEC 62366-1:2015, covering user interface design, formative and summative usability testing, and use-related risk analysis
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Official documentation
- Primary official source: https://www.iso.org/standard/63179.html
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