All terms
Quality & RiskQuality System
Use Specification
Defined description of intended users, uses, use environments, and patient populations for a device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Per IEC 62366-1, the use specification documents the intended medical indication, patient population, intended part of the body or tissue, intended user profile, intended use environment, and operating principle.What this means in practice
Drives the use-related risk analysis and human factors validation. Discrepancies between use specification and real-world clinical use are a frequent root cause of use errors.Cross-references
Used by
Things that build on this term.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
IEC·1ISO·1AAMI·1
- 1
IEC 62366-1VerifiedIECwebstore.iec.ch
- 2
ISO 13485 Standard PageVerifiedISOiso.org
- 3
AAMI - Quality Systems ResourcesVerifiedAAMIaami.org
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