IEC 62366-1:2015
Medical devices — Application of usability engineering
Usability engineering process for reducing use error
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Process: identify users, use context, use scenarios, usability testing, validation. The usability engineering file is required.
Official sources
https://www.iso.org/standard/63179.htmlSee where this text lands in your roadmap
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